Catalyst Pharmaceuticals Announces Settlement Of FIRDAPSE Patent Litigation With Teva Pharmaceuticals; Teva Will Not Market Its Generic Version Of FIRDAPSE In The U.S. Any Earlier Than February 25, 2035, If Approved By The FDA
Catalyst Pharmaceuticals Announces Settlement Of FIRDAPSE Patent Litigation With Teva Pharmaceuticals; Teva Will Not Market Its Generic Version Of FIRDAPSE In The U.S. Any Earlier Than February 25, 2035, If Approved By The FDA
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (NASDAQ:CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the Company and its licensor SERB S.A. ("SERB") have entered into a Settlement Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of FIRDAPSE (amifampridine) 10 mg tablets prior to expiration of the applicable patents.
Catalyst Pharmaceuticals, Inc.（「Catalyst」或「公司」）（納斯達克：CPRX）是一家商業階段的生物製藥公司，專注於引進、開發和商業化用於治療稀有和難治性疾病患者的新型藥物，今天宣佈公司與其許可方SERb S.A.（「SERB」）已與Teva Pharmaceuticals USA, Inc.和Teva Pharmaceuticals, Inc.（統稱爲Teva）簽署了和解協議（協議）。此協議解決了Catalyst和SERb對Teva提交的簡化新藥申請（ANDA）所提起的專利訴訟，Teva申請在相關專利到期前上市銷售FIRDAPSE（阿米法普利）10毫克片劑的仿製藥。
Pursuant to the terms of the Agreement, Teva will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if approved by the U.S. Food and Drug Administration (FDA), unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing patent litigation between Catalyst/SERB and Teva regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. The pending FIRDAPSE patent litigation against the remaining defendants, Hetero (for all of FIRDAPSE's Orange Book-listed patents) and Lupin (only for Catalyst's FIRDAPSE patent expiring in 2037), is ongoing.
根據協議的條款，Teva將不早於2035年2月25日在美國市場銷售其FIRDAPSE的仿製藥版本（如果獲得美國食品和藥物管理局（FDA）的批准），除非發生這些類型協議中通常包含的某些有限情況。根據協議，雙方將終止在美國新澤西地區地方法院正在進行的Catalyst/SERb與Teva之間有關FIRDAPSE專利的所有訴訟。針對剩餘被告Hetero（涉及所有FIRDAPSE的橙皮書列出的專利）和Lupin（僅針對Catalyst在2037年到期的FIRDAPSE專利）的FIRDAPSE專利訴訟仍在進行中。
As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
根據法律要求，公司將向美國聯邦貿易委員會和美國司法部提交機密許可協議以進行審查。
譯文內容由第三人軟體翻譯。
