What changed in this filing

/stocks — the workspaceLOADING

Item 3. Legal Proceedings

2026-02-26 compared with 2025-02-27 · 58 added, 23 removed, 41 unchanged (66% of the section changed)

LEGAL PROCEEDINGS.

On June 14, 2022, the Company received a Paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

On June 14, 2022, the Company received a Paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an abbreviated new drug application (“ANDA”) to the U.S.

Food and Drug Administration (“FDA”) seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

prior to the expiration of U.S.

16 unchanged sentences

Court of Appeals for the Federal Circuit.

On September 24, 2025, the briefing was completed, and the Company awaits a date for oral argument.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

On August 4, 2023, the Company received a Notice Letter (the “Mylan August Notice”) from Mylan Pharmaceuticals Inc.

(“Mylan”) advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s CINVANTI ANDA”) in the U.S.

(“Mylan”) advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of the CINVANTI Patents, which are listed in the Orange Book.

The Mylan August Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s CINVANTI ANDA.

On September 15, 2023, the Company filed a complaint for patent infringement of the CINVANTI Patents against Mylan in the U.S.

District Court for the District of Delaware in response to the filing of Mylan’s CINVANTI ANDA.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the CINVANTI Patents.

On November 9, 2023, the Company received an updated Notice Letter from Mylan advising that it had submitted an amendment to Mylan’s ANDA to include a Paragraph IV certification to Heron’s recently listed U.S.

The parties completed fact discovery and are in expert discovery.

A five-day bench trial is scheduled for May 19, 2025.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of filing our complaint for patent infringement, the FDA may not approve Mylan’s CINVANTI ANDA until the earlier of February 4, 2026 or resolution of the litigation.

District Court for the District of Delaware in response to the filing of Mylan’s ANDA for a generic version of CINVANTI.

May 6, 2025, the Company announced that it entered into a settlement agreement with Mylan to resolve the ongoing patent litigation in the U.S.

District Court for the District of Delaware related to Mylan’s ANDA for a generic version of CINVANTI.

Pursuant to the terms of the settlement agreement, the Company has granted Mylan a license under the Orange Book-listed patents for CINVANTI to market a generic version of CINVANTI in the United States beginning June 1, 2032, or earlier under certain customary circumstances.

In connection with the settlement, on May 6, 2025, the Court granted the Stipulation and Order of Dismissal with the U.S.

District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

On December 16, 2023, the Company received a Notice Letter (the “Mylan December Notice”) from Mylan advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S.

(“Mylan’s APONVIE ANDA”) prior to the expiration of U.S.

(“Mylan’s ANDA for a generic version of APONVIE”) prior to the expiration of U.S.

and 11,744,800 (the “APONVIE Patents”), which are listed in the Orange Book.

The Mylan December Notice alleges that the APONVIE Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s APONVIE ANDA.

On January 11, 2024, the Company filed a complaint for patent infringement of the APONVIE Patents against Mylan in the U.S.

District Court for the District of Delaware in response to Mylan filing Mylan's APONVIE ANDA.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the APONVIE Patents.

On January 26, 2024, the Court consolidated this litigation concerning Mylan’s APONVIE ANDA with the previously-filed litigation concerning Mylan’s CINVANTI ANDA.

A five-day bench trial is scheduled for May 19, 2025.

The Company intends to vigorously enforce its intellectual property rights relating to APONVIE.

As a result of filing our complaint for patent

infringement, the FDA may not approve Mylan’s APONVIE ANDA until the earlier of June 16, 2026 or resolution of the litigation.

On December 11, 2023, the Company received a Paragraph IV notice of certification (the “Slayback Notice”) from Slayback Pharma LLC ("Slayback") (now owned by Azurity Pharmaceuticals, Inc.) advising that Slayback had submitted an NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

District Court for the District of Delaware in response to Mylan filing its ANDA for a generic version of APONVIE.

On May 6, 2025, the Company announced that it entered into a settlement agreement with Mylan to resolve the ongoing

patent litigation in the U.S.

District Court for the District of Delaware related to Mylan’s ANDA for a generic version of APONVIE.

Pursuant to the terms of the settlement agreement, the Company has granted Mylan a license under the Orange Book-listed patents for APONVIE to market a generic version of APONVIE in the United States beginning June 1, 2032, or earlier under certain customary circumstances.

In connection with the settlement, on May 6, 2025, the Court granted the Stipulation and Order of Dismissal with the U.S.

District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

On December 11, 2023, the Company received a Paragraph IV notice of certification (the “Slayback Notice”) from Slayback Pharma LLC ("Slayback") (now owned by Azurity Pharmaceuticals, Inc.

(“Azurity”)) advising that Slayback had submitted a new drug application (“NDA”) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Slayback’s NDA”) prior to the expiration of the patents listed in the Orange Book.

6 unchanged sentences

District Court for the District of Delaware.

On December 12, 2024, to reflect Azurity Pharmaceuticals, Inc.’s (“Azurity”) acquisition of Slayback, the Court entered a stipulation adding Azurity and a related entity into the case.

On December 12, 2024, the Company filed a complaint against Slayback, Azurity, and related entities in the U.S.

1 unchanged sentence

12,115,254 and 12,115,255.

The parties are currently in fact discovery and preparing for claim construction.

A four-day bench trial is currently scheduled for November 17, 2025.

On May 23, 2025, the Company filed an amended complaint against Slayback, Azurity and related entities adding an allegation of patent infringement of U.S.

On September 16, 2025, the parties entered into a stipulation (Case No.

24-1363, D.I.

119) limiting the issues for trial.

On November 17, 2025, the parties commenced a two-day bench trial centered on Azurity’s §112 defenses of claims from U.S.

12,115,255 and 12,290,520 that cover CINVANTI.

On February 6, 2026, the post-trial briefing was completed, and the Company awaits a date for oral argument.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of our initial complaint for patent infringement, the FDA may not approve Slayback’s NDA until the earlier of June 12, 2026 or resolution of the litigation.

On February 28, 2025, Azurity, Azurity Pharma India LLP, and Slayback requested Post-Grant Review ("PGR") of U.S.

12,115,254 and 12,115,255 in PGR2025-00035 and PGR2025-00036, respectively.

On April 14, 2025, the Petitions were accorded a filing date.

On June 16, 2025, the Company filed a brief requesting discretionary denial of the Petitions in PGR2025-00035 and PGR2025-00036.

On July 14, 2025, the Company filed its Patent Owner Preliminary Response.

On August 14, 2025, the Patent Trial and Appeal Board discretionarily denied institution of Azurity’s PGRs.

On February 7, 2025, the Company received a Notice Letter (the “Qilu Notice”) from Qilu Pharmaceutical (Hainan) Co., Ltd and Qilu Pharma, Inc.

(“Qilu”) advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S.

(“Qilu’s ANDA for a generic version of APONVIE”) prior to the expiration of U.S.

11,744,800, 11,878,074, 12,115,254, and 12,115,255 (the “Noticed APONVIE Patents”), which are listed in the Orange Book.

On March 21, 2025, the Company filed a complaint for patent infringement of the Noticed APONVIE Patents against Qilu in the U.S.

District Court for the District of Delaware in response to Qilu's ANDA for a generic version of APONVIE.

On June 11, 2025, the Company received a Notice Letter (the “Qilu CINVANTI Notice”) from Qilu advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Qilu’s ANDA for a generic version of CINVANTI”) prior to the expiration of U.S.

and 12,290,520 (the “Noticed CINVANTI Patents”), which are listed in the

Orange Book for CINVANTI.

On July 3, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Qilu in the U.S.

District Court for the District of Delaware in response to Qilu’s ANDA for a generic version of CINVANTI.

On July 15, 2025, the Qilu CINVANTI and APONVIE litigations were consolidated.

The Company entered into a settlement agreement with Qilu to resolve the ongoing patent litigation in the U.S.

District Court for the District of Delaware related to Qilu’s ANDAs for generic versions of CINVANTI and APONVIE.

In connection with the settlement, on November 6, 2025, the Court granted the Stipulation and Order of Dismissal with the U.S.

District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

On November 19, 2025, the Company received a Paragraph IV notice of certification (the “Baxter Notice”) from Baxter Healthcare Corporation (“Baxter”) advising that Baxter had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Baxter’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of the Noticed CINVANTI Patents, which are listed in the Orange Book.

The Baxter Notice alleges that the Noticed CINVANTI patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Baxter’s ANDA for a generic version of CINVANTI.

On December 23, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Baxter and a related entity in the U.S.

District Court for the District of Delaware in response to the filing of Baxter’s ANDA for a generic version of CINVANTI.

The complaint seeks, among other relief, equitable relief enjoining Baxter from infringing the Noticed CINVANTI Patents.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of our complaint for patent infringement, the FDA may not approve Baxter’s ANDA for a generic version of CINVANTI until the earlier of May 19, 2028 or resolution of the litigation.

MINE SAF ETY DISCLOSURES.

1 unchanged sentence

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