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Amneal Pharmaceuticals LLC

www.amneal.com

Latest From Amneal Pharmaceuticals LLC

Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

Generic Sensipar: Cipla Challenges Legality of Amgen/Teva Patent Settlement

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Generic Drugs Intellectual Property

Launch Abbreviated: Teva Halts US Generic Sensipar Sales After Patent Deal With Amgen

In the course of a week, Teva received final ANDA approval for cinacalcet, launched its generic and reached a deal with Amgen to come off the market until mid-2021. The fast but short launch allowed Teva to take some sales away from Amgen without triggering entry of other ANDA sponsors who previously settled, Bernstein Senior Analyst Ronny Gal says.

Generic Drugs Intellectual Property

Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018

US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
Generic Drugs Review Pathway
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