What changed in this filing

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Item 3. Legal Proceedings

2025-02-25 compared with 2024-02-27 · 90 added, 243 removed, 136 unchanged (71% of the section changed)

5 unchanged sentences

Supernus Pharmaceuticals, Inc.

Apotex Inc., et al., C.A.

20-cv-7870 (MAS)(TJB) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug makers Apotex Inc.

and Apotex Corp.

(collectively, “Apotex”) dated May 13, 2020, directed to nine of its Oxtellar XR ® Orange Book patents.

Supernus’s U.S.

and 10,220,042 generally cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations.

The FDA Orange Book lists all nine of the Company’s Oxtellar XR ® patents as expiring on April 13, 2027.

On June 26, 2020, the Company filed a lawsuit against Apotex alleging infringement of the Company’s nine patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Apotex infringed the Company’s Oxtellar XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR ® prior to the expiration of the Company’s patents.

Filing its June 26, 2020, Complaint within 45 days of receiving Apotex’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On September 4, 2020, Apotex answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

Apotex also asserted Counterclaims seeking declaratory judgments of non-infringement for the nine Oxtellar XR ® Orange Book patents.

On October 30, 2020, the Company filed its Reply, denying the substantive allegations of Apotex’s Counterclaims.

On January 27, 2022, the Court issued an Order staying all litigation proceedings and administratively terminated the action.

The Court lifted the stay on July 1, 2022.

Pursuant to the Court’s January 27, 2022, and July 1, 2022, Orders, the 30-month Stay was extended by 152 days from November 14, 2022, to April 15, 2023.

On August 1, 2022, the Court issued an Order consolidating this lawsuit with another pending lawsuit against Apotex, C.A.

22-cv-322 (D.N.J.), discussed in Section II, below.

The Court issued a revised Scheduling Order on December 20, 2022, that further extends the 30‑month stay.

The Company entered into a settlement agreement with Apotex, and on June 27, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Apotex Inc., et al., C.A.

22-cv-322 (FLW)(TJB) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug makers Apotex Inc.

and Apotex Corp.

(collectively, “Apotex”) dated December 10, 2021, directed to one of its Oxtellar XR ® Orange Book patents.

Supernus’s U.S.

11,166,960 generally covers once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations.

The FDA Orange Book lists U.S.

11,166,960 as expiring on April 13, 2027.

On January 24, 2022, the Company filed a lawsuit against Apotex alleging infringement of U.S.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Apotex infringed U.S.

11,166,960 by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR ® prior to the expiration of U.S.

On January 27, 2022, in related action, C.A.

20-cv-7870 (D.N.J.), the Court issued an Order staying all litigation proceedings and administratively terminated that related action.

That Order further indicated that this action, i.e., C.A.

22-cv-322 (D.N.J.), will also be stayed.

The Court lifted the stay of both actions on July 1, 2022.

Pursuant to the Court’s January 27, 2022, and July 1, 2022, Orders, the 30-month Stay was extended by 152 days from November 14, 2022, to April 15, 2023.

On August 1, 2022, the Court issued an Order consolidating this lawsuit with another pending lawsuit against Apotex, C.A.

20-cv-7870 (D.N.J.), discussed in Section I, above, and administratively terminated C.A.

22-cv-322 (D.N.J.).

In related action C.A.

20-cv-7870 (D.N.J.), the Court issued a revised Scheduling Order on December 20, 2022, that further extends the 30-month stay.

The Company entered into a settlement agreement with Apotex, and on June 27, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

RiconPharma LLC, et al., C.A.

21-cv-12133 (MEF)(MAH) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug maker RiconPharma LLC dated April 20, 2021, directed to nine of its Oxtellar XR ® Orange Book patents.

Supernus’s U.S.

and 10,220,042 generally cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations.

The FDA Orange Book lists all nine of the Company’s Oxtellar XR ® patents as expiring on April 13, 2027.

On June 3, 2021, the Company filed a lawsuit against RiconPharma LLC and Ingenus Pharmaceuticals, LLC (collectively, “Ricon”) alleging infringement of the Company’s nine Oxtellar XR ® patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Ricon infringed the Company’s Oxtellar XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR ® prior to the expiration of the Company’s patents.

Filing its June 3, 2021, Complaint within 45 days of receiving Ricon’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Ricon’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On August 30, 2021, Ricon answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

Ricon also asserted Counterclaims seeking declaratory judgments of non‑infringement for the nine Oxtellar XR ® Orange Book patents.

Supernus filed a motion to strike the jury demand in Ricon’s answer.

On December 6, 2021, the Court signed an Order withdrawing the Jury demand from Ricon’s answer.

On December 13, 2021, Ricon filed an amended Answer to Supernus’s Complaint.

On December 15, 2021, the Company filed its reply, denying the substantive allegations of Ricon’s Counterclaims.

On November 22, 2022, the Court issued an Order consolidating for all purposes this lawsuit with another pending lawsuit against Ricon, C.A.

22-cv-6340 (D.N.J.), discussed in Section IV, below.

The Court issued a revised Scheduling Order on June 27, 2023, that provides a Joint Final Pretrial Order deadline of July 12, 2024.

The Company entered into a settlement agreement with Ricon, and on August 21, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable government agencies.

Supernus Pharmaceuticals, Inc.

RiconPharma LLC, et al., C.A.

22-cv-6340 (KM)(MAH) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug maker RiconPharma, LLC (“Ricon”) dated October 7, 2022, directed to one of its Oxtellar XR ® Orange Book patents.

Supernus’s U.S.

11,166,960 generally covers once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations.

The FDA Orange Book lists U.S.

11,166,960 as expiring on April 13, 2027.

On October 28, 2022, the Company filed a lawsuit against Ricon alleging infringement of U.S.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Ricon infringed U.S.

11,166,960 by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR ® prior to the expiration of U.S.

On November 22, 2022, the Court issued an Order consolidating for all purposes this lawsuit with another pending lawsuit against Ricon, C.A.

21-cv-12133 (D.N.J.), discussed in Section III, above.

The Court further ordered that this action—C.A.

22-cv-6340 (D.N.J.)—be administratively terminated.

Supernus Pharmaceuticals, Inc.

Ajanta Pharma Limited, C.A.

6 unchanged sentences

The Complaint—filed in the U.S.

District Court for the District of Delaware—alleges, inter alia, that Ajanta infringed the Company’s Oxtellar XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR ® prior to the expiration of the Company’s patents.

District Court for the District of Delaware—alleges, among other things, that Ajanta infringed the Company’s Oxtellar XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR® prior to the expiration of the Company’s patents.

Filing its October 28, 2022 Complaint within 45 days of receiving Ajanta’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Ajanta’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On January 3, 2023, Ajanta answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

asserted Counterclaims seeking declaratory judgments of non-infringement and invalidity.

On January 24, 2023, the Company filed its Reply, denying the substantive allegations of Ajanta’s Counterclaims.

The Court issued a Scheduling Order on July 13, 2023, that sets a trial date of February 10, 2025.

Ajanta also asserted Counterclaims seeking declaratory judgments of non-infringement and invalidity.

24, 2023, the Company filed its Reply, denying the substantive allegations of Ajanta’s Counterclaims.

The Court issued a Scheduling Order on July 13, 2023, that set a trial date of February 10, 2025.

The Company entered into a settlement agreement with Ajanta, and on January 18, 2024, a stipulation of dismissal without prejudice was entered by the U.S.

1 unchanged sentence

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Aurobindo Pharma Ltd.

and Aurobindo Pharma USA, Inc., C.A.

24-cv-9380 (KMW) (MJS) (D.N.J)

The Company received a Paragraph IV Notice Letter from generic drug maker Aurobindo Pharma Ltd.

dated August 9, 2024, directed to eleven of its Oxtellar XR® Orange Book patents.

Supernus’s U.S.

and 11,896,599 generally cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations.

The FDA Orange Book lists all eleven of the Company’s Oxtellar XR® patents as expiring on April 13, 2027.

On September 23, 2024, the Company filed a lawsuit against Aurobindo Pharma Ltd.

and Aurobindo Pharma USA, Inc.

(collectively, “Aurobindo”) alleging infringement of the Company’s eleven Oxtellar XR® patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, among other things, that Aurobindo infringed the Company’s Oxtellar XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR® prior to the expiration of the Company’s patents.

Filing its September 23, 2024, Complaint within 45 days of receiving Aurobindo’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Aurobindo’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

The Company entered into a settlement agreement with Aurobindo, and on December 9, 2024, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Trokendi XR ®

11 unchanged sentences

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Ajanta infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

District Court for the District of New Jersey—alleges, among other things, that Ajanta infringed the Company’s Trokendi XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR® prior to the expiration of the Company’s patents.

Filing its March 26, 2021, Complaint within 45 days of receiving Ajanta’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Ajanta’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

3 unchanged sentences

Following the initial Rule 16 Scheduling Conference, the Court issued a case schedule.

On December 17, 2021, the Court issued an order consolidating this lawsuit with the lawsuit against Torrent, discussed in Section VII, below.

On December 17, 2021, the Court issued an order consolidating this lawsuit with the lawsuit against Torrent, discussed in Section IV, below.

The consolidation order extended the 30‑month stay preventing the FDA from approving Ajanta’s ANDA to December 16, 2023.

5 unchanged sentences

21-cv-14268 (GC)(DEA) (D.N.J.);

Supernus Pharmaceuticals, Inc.

Ajanta Pharma Limited, et al., Appeal No.

2024-1606 (Fed.

The Company received a Paragraph IV Notice Letter from generic drug maker Torrent Pharmaceuticals Ltd.

7 unchanged sentences

and Torrent Pharma Inc.

(collectively, “Torrent”) alleging infringement of the Company’s Trokendi XR ® Orange Book patents.

(collectively,

“Torrent”) alleging infringement of the Company’s Trokendi XR® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Torrent infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

District Court for the District of New Jersey—alleges, among other things, that Torrent infringed the Company’s Trokendi XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR® prior to the expiration of the Company’s patents.

Filing its July 28, 2021 Complaint within 45 days of receiving Torrent’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Torrent’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

3 unchanged sentences

Following the initial Rule 16 Scheduling Conference, the Court issued a case schedule.

On December 17, 2021, the Court issued an order consolidating this lawsuit with the lawsuit against Ajanta, discussed in Section VI, above.

On December 17, 2021, the Court issued an order consolidating this lawsuit with the lawsuit against Ajanta, discussed in Section III, above.

The Court held a bench trial between July 31, 2023, and August 3, 2023.

2 unchanged sentences

On January 30, 2024, the Court issued a Trial Opinion and Order, deciding in Supernus’s favor that the patent claims that Supernus asserted at trial against Torrent are both valid and infringed.

The parties submitted a proposed final Judgment on February 20, 2024.

Supernus Pharmaceuticals, Inc.

Lupin Limited, et al., C.A.

21-cv-1293 (MN) (D.

The Company received a Paragraph IV Notice Letter from generic drug maker Lupin Limited dated July 29, 2021, directed to ten of its Trokendi XR ® Orange Book patents.

Supernus’s U.S.

and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations.

The FDA Orange Book currently lists United States Patent No.

8,298,576 as expiring on April 4, 2028, and United States Patent Nos.

and 10,314,790 as expiring on November 16, 2027.

On September 10, 2021, the Company filed a lawsuit against Lupin Limited, Lupin Atlantis Holdings S.A., Nanomi B.V., Lupin Inc., and Lupin Pharmaceuticals, Inc.

(collectively, “Lupin”) alleging infringement of the Company’s Trokendi XR ® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the District of Delaware—alleges, inter alia, that Lupin infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

Filing its September 10, 2021, Complaint within 45 days of receiving Lupin’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Lupin’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On December 20, 2021, Lupin answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

Lupin also asserted Counterclaims seeking declaratory judgments of non‑infringement and invalidity for the Trokendi XR ® Orange Book patents.

On January 10, 2022, the Company filed its reply, denying the substantive allegations of Lupin’s Counterclaims.

On May 11, 2023, the Company and Lupin filed a Stipulation and [Proposed] Order to Amend Scheduling Order, that proposed an extension of the 30-month stay to March 30, 2024, but also stated that “the parties do not object to the Court exercising its discretion to further extend the expiration of the 30-month stay beyond the Proposed Date of March 30, 2024 as the Court deems appropriate.” The Company entered into a settlement agreement with Lupin, and on November 13, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of Delaware.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Zydus Pharmaceuticals (USA) Inc., et al., C.A.

21-cv-17104 (GC)(LHG) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug maker Zydus Pharmaceuticals (USA) Inc.

dated August 5, 2021, directed to ten of its Trokendi XR ® Orange Book patents.

Supernus’s U.S.

and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations.

The FDA Orange Book currently lists United States Patent No.

8,298,576 as expiring on April 4, 2028, and United States Patent Nos.

and 10,314,790 as expiring on November 16, 2027.

On September 17, 2021, the Company filed a lawsuit against Zydus Pharmaceuticals (USA) Inc.

and Cadila Healthcare Limited (collectively, “Zydus”) alleging infringement of the Company’s Trokendi XR ® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Zydus infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

Filing its September 17, 2021, Complaint within 45 days of receiving Zydus’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Zydus’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

The August 5, 2021, Paragraph IV Notice Letter from Zydus Pharmaceuticals (USA) Inc.

concerns Zydus’s proposed generic equivalent of the 200 mg strength of Trokendi XR ® .

[1] The August 5, 2021, Paragraph IV Notice Letter referenced herein does not concern the same ANDA as the one that was at issue in the previous lawsuit.

On December 28, 2021, Zydus answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

On April 29, 2022, the Court issued a scheduling order.

The Company entered into a settlement agreement with Zydus, and on January 6, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Alkem Laboratories Ltd., C.A.

22-cv-3511 (EEB)(SRH) (N.D.

The Company received a Paragraph IV Notice Letter from generic drug maker Alkem Laboratories Ltd.

dated May 25, 2022, directed to ten of its Trokendi XR ® Orange Book patents.

Supernus’s U.S.

[1] Previously, the Company was in a lawsuit against Zydus Pharmaceuticals (USA) Inc.

and Cadila Healthcare Limited concerning an Abbreviated New Drug Application (“ANDA”) for Zydus’s proposed generic equivalents of the 25 mg, 50 mg, and 100 mg strengths of Trokendi XR ® .

A settlement agreement was entered into between the Company and Zydus Pharmaceuticals (USA) Inc.

and Cadila Healthcare Limited concerning the previous lawsuit.

See https://www.sec.gov/Archives/edgar/data/1356576/000110465917031191/a17-10293_1ex10d1.htm.

and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations.

The FDA Orange Book currently lists United States Patent No.

8,298,576 as expiring on April 4, 2028, and United States Patent Nos.

and 10,314,790 as expiring on November 16, 2027.

On July 6, 2022, the Company filed a lawsuit against Alkem Laboratories Ltd.

(“Alkem”) alleging infringement of the Company’s Trokendi XR ® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the Northern District of Illinois—alleges, inter alia, that Alkem infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

Filing its July 6, 2022, Complaint within 45 days of receiving Alkem’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Alkem’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On October 3, 2022, Alkem answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

The Company entered into a settlement agreement with Alkem, and on March 20, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the Northern District of Illinois.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Reddy’s Laboratories, Ltd., et al., C.A.

22-cv-4705 (GC)(JBD) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug makers Dr, Reddy’s Laboratories Ltd.

Reddy’s Laboratories, Inc.

dated June 9, 2022, directed to ten of its Trokendi XR ® Orange Book patents.

Supernus’s U.S.

and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations.

The FDA Orange Book currently lists United States Patent No.

8,298,576 as expiring on April 4, 2028, and United States Patent Nos.

and 10,314,790 as expiring on November 16, 2027.

On July 22, 2022, the Company filed a lawsuit against Dr, Reddy’s Laboratories Ltd.

Reddy’s Laboratories, Inc.

(“DRL”) alleging infringement of the Company’s Trokendi XR ® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that DRL infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

Filing its July 22, 2022, Complaint within 45 days of receiving DRL’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving DRL’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On October 7, 2022, DRL answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

The Company entered into a settlement agreement with DRL, and on June 28, 2023, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

The District Court entered a Final Judgment in Supernus’s favor on February 22, 2024.

On March 4, 2024, Torrent filed a Notice of Appeal of the Final Judgment with the U.S.

Court of Appeals for the Federal Circuit.

The Federal Circuit docketed the appeal as Supernus Pharmaceuticals, Inc.

Ajanta Pharma Limited because the lawsuit against Torrent was previously consolidated with the lawsuit against Ajanta ( see Section III above).

The Court has not set the date for oral argument.

Supernus Pharmaceuticals, Inc.

8 unchanged sentences

and 10,314,790 as expiring on November 16, 2027.

On July 26, 2023, the Company filed a lawsuit against Ascent Pharmaceuticals Inc., Camber Pharmaceuticals, Inc., and Hetero Labs Ltd.

On July 26, 2023, the Company filed a lawsuit against Ascent Pharmaceuticals Inc., ("Ascent Pharma") Camber Pharmaceuticals, Inc., and Hetero Labs Ltd.

(collectively, “Ascent”) alleging infringement of the Company’s Trokendi XR® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the District of New Jersey—alleges, inter alia, that Ascent infringed the Company’s Trokendi XR ® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR ® prior to the expiration of the Company’s patents.

District Court for the District of New Jersey—alleges, among other things, that Ascent infringed the Company’s Trokendi XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR® prior to the expiration of the Company’s patents.

Filing its July 26, 2023 Complaint within 45 days of receiving Ascent’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Ascent’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

4 unchanged sentences

On October 11, 2023, Ascent Pharma answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-infringement and invalidity.

On November 21, 2023, the Court issued a scheduling order that provides for a Pretrial Conference in July 2025 and a bench trial in July/August 2025.

Pretrial discovery is ongoing as of the date of this letter.

The Company entered into a settlement agreement with Ascent Pharma, and on May 2, 2024, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Supernus Pharmaceuticals, Inc.

Ascent Pharmaceuticals Inc., et al., C.A.

23-cv-5720 (E.D.N.Y.)

The Company received a Paragraph IV Notice Letter from generic drug maker Ascent Pharmaceuticals Inc.

dated June 15, 2023, directed to ten of its Trokendi XR® Orange Book patents.

Micro Labs Ltd., et al., C.A.

24-cv-9338 (ZNQ)(JTQ) (D.N.J.)

The Company received a Paragraph IV Notice Letter from generic drug maker Micro Labs Ltd.

dated August 13, 2024, directed to ten of its Trokendi XR® Orange Book patents.

Supernus’s U.S.

and 10,314,790 generally cover once-a-day topiramate formulations and methods of treating or preventing seizures and migraines using those formulations.

The FDA Orange Book currently lists United States Patent No.

8,298,576 as expiring on April 4, 2028, and United States Patent Nos.

The FDA Orange Book currently lists U.S.

8,298,576 as expiring on April 4, 2028, and U.S.

and 10,314,790 as expiring on November 16, 2027.

On July 28, 2023, the Company filed a lawsuit against Ascent Pharmaceuticals Inc., Camber Pharmaceuticals, Inc., and Hetero Labs Ltd.

(collectively, “Ascent”) alleging infringement of the Company’s Trokendi XR® Orange Book patents.

On September 20, 2024, the Company filed a lawsuit against Micro Labs Ltd.

and Micro Labs USA, Inc.

(collectively, “Micro Labs”) alleging infringement of the Company’s Trokendi XR® Orange Book patents.

The Complaint—filed in the U.S.

District Court for the Eastern District of New York—alleges, inter alia, that Ascent infringed the Company’s Trokendi XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR® prior to the expiration of the Company’s patents.

Filing its July 28, 2023, Complaint within 45 days of receiving Ascent’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Ascent’s ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

On October 25, 2023, Supernus filed a notice of voluntary dismissal of the Complaint without prejudice.

The Court dismissed the case without prejudice on October 30, 2023.

The October 30, 2023, dismissal does not impact the co‑pending matter against Ascent, C.A.

23-cv-4015 (D.N.J.), discussed in Section XII, above.

District Court for the District of New Jersey—alleges, among other things, that Micro Labs infringed the Company’s Trokendi XR® patents by submitting to the FDA an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Trokendi XR®

prior to the expiration of the Company’s patents.

Filing its September 20, 2024, Complaint within 45 days of receiving Micro Labs’ Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Micro Labs’ ANDA for 30 months from the date of the Company’s receipt of the Paragraph IV Notice Letter.

The Company entered into a settlement agreement with Micro Labs, and on December 31, 2024, a stipulation of dismissal without prejudice was entered by the U.S.

District Court for the District of New Jersey.

The agreement has been submitted to the applicable governmental agencies.

Sage Chemical, Inc., et al.

3 unchanged sentences

and TruPharma, LLC filed a lawsuit in the United States District Court for the District of Delaware alleging that Supernus Pharmaceuticals, Inc., Britannia Pharmaceuticals Limited (“Britannia”), and US WorldMeds Partners, LLC (“US WorldMeds”) violated state and federal antitrust law in connection with APOKYN® (apomorphine HCl).

On October 16, 2022, Plaintiffs amended their complaint to add additional defendants MDD US Enterprises, LLC, MDD US Operations, LLC (each a subsidiary of Supernus Pharmaceuticals, Inc.), USWM, LLC (“USWM”), Paul Breckinridge Jones, Sr., Herbert Lee Warren, Jr., Henry Van Den Berg, and Kristin L.

On October 16, 2022, Plaintiffs amended their complaint to add additional defendants MDD US Enterprises, LLC, MDD US Operations, LLC (each a subsidiary of Supernus Pharmaceuticals, Inc.), USWM, LLC (“USWM”), and individual defendants Paul Breckinridge Jones, Sr., Herbert Lee Warren, Jr., Henry Van Den Berg, and Kristin L.

On January 10, 2023, Defendants filed an Omnibus Motion to Dismiss the Amended Complaint seeking dismissal of each of Plaintiffs’ claims and the lawsuit in its entirety and US WorldMeds with USWM, Britannia, and the group of individual defendants each filed separate motions to dismiss.

As of April 12, 2023, briefing on those motions is now complete.

Those motions remain pending.

On April 10, 2023, the Court issued a scheduling order that provides for a Pretrial Conference on March 7, 2025, and a jury trial beginning on March 24, 2025.

Pretrial discovery is ongoing as of the date of this filing.

On June 10, 2021, Newron Pharmaceuticals S.p.A.

("Newron"), Zambon S.p.A.

("Zambon") and Supernus Pharmaceuticals, Inc.

(the "Company"), through its subsidiary MDD US Operations, LLC (collectively, "Plaintiffs"), initiated litigation against generic drug makers Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., MSN Laboratories Private Limited ("MSN"), Optimus Pharma Pvt Ltd, Prinston Pharmaceutical, Inc., RK Pharma, Inc.

and Zenara Pharma Private Limited (collectively, "Defendants") for infringement of three FDA Orange Book patents covering XADAGO ® , the Company's once-daily product indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing "off" episodes.

8,076,515, 8,278,485 and 8,283,380 (collectively, the "XADAGO Patents") cover the pharmaceutical formulation of and methods of treatment with safinamide.

The XADAGO Patents expire between June 2027 and March 2031.

The Company has a license agreement with Zambon, Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO was under the 5-year FDA exclusivity period that expired on March 21, 2022.

The Complaint - filed in the U.S.

District Court for the District of Delaware - alleges that the Defendants infringed the XADAGO Patents by submitting to the U.S.

Food and Drug Administration (FDA) Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of XADAGO prior to the expiration of the patents.

Filing the Complaint within 45 days of receiving each of the Defendants' Paragraph IV notice letters entitles the Plaintiffs to an automatic stay preventing the FDA from approving the Defendants' ANDAs for 30 months from the date of the Plaintiffs' receipt of the Paragraph IV Notice Letters.

On March 22, 2022, defendant Optimus Pharma Pvt Ltd was dismissed from the case without prejudice.

Between January 5, 2023, and November 22, 2023, Plaintiffs entered into settlement agreements with all remaining defendants.

The settlement agreements have been submitted to the applicable governmental agencies.

The case is closed.

On May 9, 2024, and May 28, 2024, respectively, the Court denied the Defendants’ omnibus motion and the Britannia motion to dismiss.

On May 31, 2024, and June 4, 2024, respectively, the Court granted the individual defendants’ motion to dismiss and the US WorldMeds and USWM motion to dismiss.

On December 6, 2024, Plaintiffs filed a second amended complaint, which added back to the case US WorldMeds and USWM.

On November 4, 2024, the Court issued a scheduling order that provides for a Pretrial Conference on December 10, 2025, and a jury trial beginning on January 5, 2026.

Pretrial discovery is ongoing as of the date of this submission.

On January 3, 2025, the Court issued an Oral Order requiring the parties to “engage in in-person mediation in good faith” and jointly select an agreed-upon mediator.

The parties are working to schedule the mediation to occur in late April 2025 in compliance with Court’s Oral Order that the mediation conference “occur no later than May 2, 2025 (unless the parties stipulate to a later date and such date is approved by the Court)."

US WorldMeds Partners, LLC v.

Federal Insurance Company, et al, Case Nos.

and 24-CI-6988) (D.Del)

Alleged competitors of Supernus filed a lawsuit against the Company, MDD US Enterprises, LLC, and MDD Operations, LLC (collectively "Enterprises") and others in the United States District Court for the District of Delaware (the “Underlying Action”).

After a dispute over coverage under certain insurance policies arose, Enterprises commenced a declaratory judgment action against Federal Insurance Company, RSUI Indemnity Company, and StarStone Specialty Insurance Company and others to recover insurance benefits.

US WorldMeds Partners, LLC, RSUI and StarStone commenced similar declaratory judgment actions in connection with the Underlying Action.

These related actions were recently consolidated.

This case is in its early stages.

Supernus awaits responsive pleadings to its Complaint.

Discovery has not yet commenced in the consolidated action.

An initial post consolidation court conference is scheduled for February 12, 2025.

Supernus Pharmaceuticals, Inc.

Old Republic Insurance Company, 8:24-cv-03733-PJM) (D.Maryland)

The action seeks recovery of insurance benefits in connection with the Underlying Action in the US WorldMeds Partners, LLC v Federal Insurance Company case.

This case is in its early stages.

Supernus awaits a responsive pleading to its Complaint.

Discovery has not yet commenced.

Adamas Litigation

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On April 19, 2023, the plaintiff appealed the District Court's dismissal of the Federal False Claims Act claim.

The appeal remains pending in the United States Court of Appeals for the Ninth Circuit.

On February 20, 2024, the plaintiff filed a motion for an indicative ruling and to set aside the judgment in the District Court, based on the same arguments raised in his appeal.

That motion was fully briefed and the District Court determined that the motion for an indicative ruling was suitable for determination without a hearing.

On May 7, 2024, the District Court denied the plaintiff’s motion for an indicative ruling.

The appeal is fully briefed, and the Ninth Circuit heard oral argument on November 21, 2024.

On January 29, 2025, the Ninth Circuit affirmed the District Court’s order dismissing the litigation.

The plaintiff intends to file a Petition for Panel and En Banc Rehearing and has asked the Ninth Circuit to extend his filing deadline until March 31, 2025.

On December 10, 2019, a putative class action lawsuit alleging violations of the federal securities laws was filed by Ali Zaidi against Adamas and certain of Adamas's former directors and officers in federal court in the Northern District of California (Case No.

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On October 31, 2023, the Court granted the parties' stipulation staying all proceedings and vacating all existing deadlines.

The deadline for plaintiff to file a motion for preliminary approval of the class action settlement, or for the parties to submit a joint report updating the court of settlement status, is March 1, 2024.

On March 16, 2020, a shareholder derivative lawsuit was filed by Patrick Van Camp in federal court in the Northern District of California (Case No.

4:20-cv-01815) naming Adamas and certain of Adamas's former directors and officers as defendants.

This lawsuit alleged certain of Adamas's former directors and officers breached fiduciary duties and violated the Securities Exchange Act of 1934.

Adamas was named as a nominal defendant only.

On April 6, 2020, another, virtually identical, shareholder derivative lawsuit was filed by James Druzbik in federal court in the Northern District of California (Case No.

4:20- cv-02320) naming Adamas and certain of Adamas's former directors and officers as defendants.

This lawsuit contained the same allegations, claims, and defendants as the first derivative action.

Adamas is named as a nominal defendant only.

In both actions, Plaintiffs sought unspecified monetary damages and other relief.

These actions were consolidated.

On May 16, 2023 the court entered an order dismissing the consolidated actions, without prejudice.

The consolidated cases were closed on June 7, 2023.

On April 2, 2024, the Court preliminarily approved the settlement of the case, including a $4.7 million payment from insurers, subject to further consideration at a settlement hearing to be held in September 2024.

On September 27, 2024, the Court granted final approval of the class action settlement, dismissed the lawsuit with prejudice, and final judgment was entered.

Adamas believes it has strong factual and legal defenses to all actions and intends to defend itself vigorously.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings