1. Generics Bulletin

Cosette Launches First US Generic To AbbVie’s Rectiv

Commercial Shipments To Commence Imminently, With 180 Days Of CGT Exclusivity

 
• By Urtė Fultinavičiūtė

Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.

Packaging and tube of Cosette's nitroglycerin ointment
AbbVie’s Rectiv was approved in June 2011 • Source: Business Wire

The US Food and Drug Administration has given the green light to Cosette Pharmaceuticals to launch the first generic version of originator AbbVie’s Rectiv (nitroglycerin) ointment, 0.4%.

The agency approved Cosette’s abbreviated new drug application with 180 days of competitive generic therapy exclusivity. The company said it will “imminently commence commercial shipments” to trigger the six-month exclusivity...

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