Legal Proceedings
−Removed: In March 2025, we received a notice from Zydus Lifesciences Global FZE (Zydus FZE) that it had filed an abbreviated new drug application, or ANDA, with the FDA seeking approval of a generic version of INGREZZA SPRINKLE (valbenazine).
−Removed: The ANDA contained a Paragraph IV Patent Certification alleging that certain of our patents covering INGREZZA SPRINKLE are invalid and/or will not be infringed by Zydus FZE’s importation, manufacture, use or sale of the medicine for which the ANDA was submitted.
−Removed: We filed suit in the U.S.
−Removed: District Court for the District of Delaware in April 2025 against Zydus Pharmaceuticals (USA) Inc.
−Removed: and its affiliates Zydus FZE, Zydus Worldwide DMCC (entity subsequently dismissed), Zydus Lifesciences Limited, and Zydus Healthcare (USA) LLC (entity subsequently dismissed) (collectively, Zydus).
−Removed: We also filed suit in the U.S.
−Removed: District Court for the District of New Jersey in April 2025 against Zydus seeking to prevent Zydus from selling a generic version of INGREZZA SPRINKLE.
−Removed: In January 2025, we filed suit in the U.S.
−Removed: District Court for the District of Delaware against Spruce Biosciences, Inc.
−Removed: (Spruce), seeking a declaratory judgement of invalidity of one of Spruce’s patents.
−Removed: In June 2025, the Court dismissed the case without prejudice for lack of case or controversy.
−Removed: In January 2025, we also initiated post-grant review against another Spruce patent in the U.S.
−Removed: Patent and Trademark Office.
−Removed: Spruce disclaimed all challenged claims of that patent.
−Removed: In addition, we have initiated judicial and administrative proceedings against Spruce patents in other jurisdictions.
−Removed: From time to time, we may also become subject to other legal proceedings or claims arising in the ordinary course of our business.
+Added: For a description of our legal proceedings, see Note 10 to the condensed consolidated financial statements, which is incorporated herein by reference.
+Added: From time to time, we may become subject to other legal proceedings or claims arising in the ordinary course of our business.
We currently believe that none of the claims or actions pending against us is likely to have, individually or in the aggregate, a material adverse effect on our business, financial condition, or results of operations.
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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.