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These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of our Orange Book-listed patents covering NUPLAZID (Pimavanserin I Cases).
−Removed: The cases have been assigned to the Honorable Richard G.
−Removed: On September 1, 2020, Aurobindo filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.
−Removed: On September 22, 2020, we filed our answer to Aurobindo’s counterclaims.
−Removed: On August 31, 2020, Teva filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.
−Removed: On September 21, 2020, we filed our answer to Teva’s counterclaims.
−Removed: On October 5, 2020, Hetero filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.
−Removed: On October 26, 2020, we filed our answer to Hetero’s counterclaims.
−Removed: On September 30, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On November 5, 2020, we filed our first amended complaint against MSN in the United States District Court for the District of Delaware, alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On November 19, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On December 10, 2020, we filed our answer to MSN’s counterclaims.
−Removed: On November 2, 2020, Zydus filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity.
−Removed: On November 23, 2020, we filed our answer to Zydus’s counterclaims.
−Removed: On December 8, 2020, the parties’ joint proposed scheduling order was entered by Judge Andrews.
−Removed: On April 7, 2021, we filed our first amended complaints against Hetero and Teva and our second amended complaint against MSN, to include an additional Orange Book-listed patent covering NUPLAZID.
−Removed: On April 8, 2021, we filed our first amended complaint against Zydus and on April 9, 2021, we filed our first amended complaint against Aurobindo.
−Removed: On April 20, 2021, MSN filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On April 21, 2021, Teva filed its answer, affirmative defenses, and counterclaims to our first amended complaint, seeking declaratory judgments of noninfringement and invalidity.
−Removed: On April 22, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to our first amended complaint, seeking declaratory judgments of noninfringement and invalidity.
−Removed: On April 22, 2021, Aurobindo filed its answer, affirmative defenses, and counterclaims to our first amended complaint, seeking declaratory judgments of noninfringement and invalidity.
−Removed: On May 11, 2021, we filed our answer to MSN’s counterclaims.
−Removed: On May 12, we filed our answer to Teva’s counterclaims.
−Removed: On May 13, we filed our answer to Zydus’s counterclaims and its answer to Aurobindo’s counterclaims.
We entered into an agreement effective April 22, 2021 with Hetero settling all claims and counterclaims in the litigation.
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The Hetero case was dismissed by joint agreement on May 3, 2021.
−Removed: On August 27, 2021, we filed our second amended complaint against Zydus to include an additional Orange Book-listed patent covering NUPLAZID.
−Removed: On September 10, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity.
−Removed: Also on September 10, 2021, the parties filed their Joint Claim Construction Chart.
−Removed: On October 1, 2021, we filed our answer to Zydus’s counterclaims.
−Removed: On November 30, 2021, we filed a stipulation and proposed order to dismiss two of our Orange Book-listed patents covering NUPLAZID against Teva, which was ordered by the Court on December 1, 2021.
−Removed: On January 28, 2022, the parties filed their Joint Claim Construction Brief and Appendix.
−Removed: On February 23, 2022, the Court heard oral argument on claim construction.
−Removed: On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting our construction on two terms, Defendants’ construction on two terms, and one agreed-upon construction.
−Removed: On February 28, 2022, we filed a stipulation and proposed order to dismiss one patent against MSN, which was ordered by the Court on March 1, 2022.
−Removed: On March 10, 2022, we filed a stipulation and proposed order to dismiss one patent against Teva, which was ordered by the Court on March 10, 2022.
−Removed: On March 22, 2022, we filed a stipulation and proposed order to dismiss seven patents against Aurobindo, which was ordered by the Court on March 22, 2022.
−Removed: On March 30, 2022, we filed a stipulation and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022.
−Removed: On April 22, 2022, we filed a stipulation and proposed order of non-infringement against Aurobindo regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 22, 2022.
−Removed: On April 26, 2022, we filed a stipulation and proposed order of non-infringement against MSN regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 26, 2022.
−Removed: On April 26, 2022, we filed a stipulation and proposed order of non-infringement against Teva regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 27, 2022.
−Removed: On May 10, 2022, we filed our second amended complaint against Teva to include an additional Orange Book-listed patent covering NUPLAZID.
−Removed: On May 18, 2022, we filed a stipulation and proposed order of non-infringement against Zydus regarding certain of our Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on May 19, 2022.
−Removed: On May 24, 2022, Teva filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On June 1, 2022, we filed our second amended complaint against Aurobindo alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On June 2, 2022, we filed our third amended complaint against Zydus alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On June 14, 2022, we filed our answer to Teva’s counterclaims.
−Removed: June 15, 2022, Aurobindo filed its answer, affirmative defenses, and counterclaims to our second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On June 16, 2022, Zydus filed its answer, affirmative defenses, and counterclaims to our third amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of our Orange Book-listed patents covering NUPLAZID.
−Removed: On July 6, 2022, we filed our answer to Aurobindo’s counterclaims.
−Removed: On September 7, 2022, the consolidated cases were reassigned to the Honorable Judge Gregory B.
−Removed: On September 30, 2022, we filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining Defendants, which was ordered by the Court on October 4, 2022.
−Removed: On October 21, 2022, we filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases).
−Removed: On March 29, 2023, following Aurobindo’s conversion of various patent certifications from Paragraph IV certifications to Paragraph III certifications in connection with the Pimavanserin I Case, we filed a stipulation and proposed order in the Pimavanserin I Case to dismiss the remaining asserted patents against Aurobindo.
−Removed: This stipulation was ordered by the Court on March 30, 2023.
+Added: On September 30, 2022, we filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining defendants Aurobindo and MSN, which was ordered by the Court on October 4, 2022.
+Added: On October 21, 2022, we filed additional complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases).
We entered into an agreement, effective March 31, 2023, with Zydus settling all claims and counterclaims in the Pimavanserin I Cases and Pimavanserin II Cases.
−Removed: The agreement allows Zydus to launch its generic pimavanserin 10 mg products on September 23, 2036 and 34 mg products on February 27, 2038, subject to certain triggers for earlier launch.
−Removed: On April 4, 2023, we filed a stipulation and proposed order to dismiss all claims and counterclaims between us and Zydus in the Pimavanserin I Cases and Pimavanserin II Cases, which was ordered by the Court on April 5, 2023.
+Added: The agreement allows Zydus to launch its generic pimavanserin 10 mg tablet products on September 23, 2036 and 34 mg capsule products on February 27, 2038, subject to certain triggers for earlier launch.
+Added: The Zydus case was dismissed by joint agreement on April 5, 2023.
As a result of the above, only MSN remained as an active defendant in the Pimavanserin I Cases.
−Removed: On April 6, 2023, we and MSN filed a stipulation and proposed order requesting adjournment of the final pre-trial conference and trial, and requesting resolution of the remaining issue – MSN’s validity challenge of the sole patent in suit – through summary judgment briefing by the parties, which was ordered by the Court on April 10, 2023.
−Removed: Briefing was completed on June 28, 2023 and oral argument took place on September 27, 2023.
−Removed: On December 13, 2023, the Court ruled in our favor on the summary judgment motions – denying MSN’s motion for summary judgment of invalidity and granting our cross-motion for no invalidity.
−Removed: MSN had previously stipulated to infringement of the patent-in-suit.
−Removed: On January 11, 2024, the District Court entered final judgment in our favor that MSN’s submission of ANDA No.
−Removed: 214925 was an act of infringement in the Pimavanserin I Case.
−Removed: On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from the December 13, 2023 Memorandum Order of the United States District Court for the District of Delaware, and final judgment entered on January 11, 2024.
−Removed: On February 12, 2024, we filed an Entry of Appearance for the appeal to the United States Court of Appeals for the Federal Circuit.
−Removed: MSN’s Opening Appeal Brief is due on March 29, 2024.
+Added: On January 11, 2024, following summary judgment motions, the District Court entered final judgment in our favor that MSN’s submission of ANDA No.
+Added: 214925 was an act of infringement in the Pimavanserin I Case and the ’740 patent was not invalid.
+Added: On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from the final judgment entered on January 11, 2024.
+Added: The appeal is fully briefed and awaiting a date for oral argument.
In connection with the Pimavanserin II cases, MSN and Aurobindo are the remaining defendants.
−Removed: On December 13, 2023, the Court issued a claim construction order finding in favor of us on all disputed terms of the patent-in-suit.
−Removed: Fact discovery closes on March 21, 2024.
−Removed: Trial is scheduled in the matter for December 3, 2024 to December 5, 2024.
+Added: A bench trial was conducted from December 3, 2024 to December 6, 2024 in the matter.
+Added: Post-trial briefing was completed on February 12, 2025 and we are awaiting the final decision of the Court.
+Added: On February 14, 2025, we filed a complaint against Zydus Lifesciences Limited, Zydus Worldwide DMCC, and Zydus Pharmaceuticals (USA) Inc.
+Added: (collectively “Zydus”) in the United States District Court for the District of Delaware, alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID (Pimavanserin) by Zydus’ proposed 34 mg pimavanserin tablet product.
+Added: Zydus has not responded to the complaint as of yet and there is no schedule in place for the case.
Securities Class Action
−Removed: On April 19, 2021, a purported stockholder of us filed a putative securities class action complaint (captioned Marechal v.
−Removed: Acadia Pharmaceuticals Inc., Case No.
+Added: On April 19, 2021, a purported stockholder of us filed a putative securities class action complaint (captioned City of Birmingham Relief Retirement Systems v.
+Added: Acadia Pharmaceuticals Inc.
21-cv-0762) in the U.S.
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The amended complaint seeks unspecified monetary damages and other relief.
−Removed: Defendants filed a motion to dismiss the amended complaint on February 15, 2022.
−Removed: On September 27, 2022, the Court issued an order denying Defendants’ motion to dismiss.
−Removed: Defendants filed their answer to the amended complaint on October 19, 2022, and filed a motion for reconsideration on October 25, 2022.
−Removed: On February 2, 2023, the Court issued an order denying the motion for reconsideration.
−Removed: On August 21, 2023, plaintiffs filed a motion for class certification.
−Removed: Briefing on that motion concluded on January 12, 2024, and the Court will hear oral argument on the motion on February 28, 2024.
−Removed: The parties are currently engaged in discovery.
−Removed: The cutoff for fact discovery is June 13, 2024.
+Added: On March 11, 2024, the Court granted plaintiffs’ motion for class certification and appointment of class representatives and class counsel.
+Added: The parties are currently engaged in expert discovery, which is scheduled to close on June 13, 2025.
+Added: Opt-Out Litigation
+Added: On March 7, 2024, a purported stockholder of the Company filed a complaint (captioned Alger Dynamic Opportunities Fund v.
+Added: Acadia Pharmaceuticals, Inc.
+Added: 24-cv-00451) in the U.S.
+Added: District Court for the Southern District of California against us and one executive officer.
+Added: The complaint is based on the same underlying allegations as the Securities Class Action described above, and alleged claims under federal and state securities laws, and for common law fraud and negligent misrepresentations.
+Added: On May 24, 2024, Defendants moved to dismiss the complaint.
+Added: On October 31, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss.
+Added: The Court dismissed with leave to amend the purported stockholder’s state and common law claims, as well as the claim brought under Section 18(a) of the Securities Exchange Act of 1934, as amended.
+Added: Defendants filed their answer to the Sections 10(b) and 20(a) claims on December 16, 2024.
+Added: On January 13, 2025, the Court stayed this suit pending the outcome of the Securities Class Action.
Derivative Suit
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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.