Amneal Pharmaceuticals, Inc.
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Latest From Amneal Pharmaceuticals, Inc.
Amneal is set to benefit from 180 days of US exclusivity for its norelgestromin and ethinyl estradiol contraceptive patch product after receiving FDA approval with a competitive generic therapy designation. The generic will be the only competitor to Mylan’s Xulane version.
Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.
The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- Amedra Pharmaceuticals LLC
- Amneal Pharmaceuticals, LLC
- CorePharma LLC
- Gemini Laboratories, LLC
- Impax Generics
- Impax Laboratories, Inc. (IPXL)
- Impax Specialty Pharma
- Lineage Therapeutics Inc.
- Tower Holdings, Inc.