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Federal Court Shuts Down Viatris Sitagliptin Challenge Following West Virginia Defeat

Originator Merck Has Settled With Nearly Half A Dozen Firms On Generic Production

 
• By Chloe Kent

Viatris has suffered a second defeat in its challenge to Merck’s sitagliptin dihydrogen phosphate exclusivity in the US Court of Appeals for the Federal Circuit, shortly after experiencing a similar blow in the District Court for the Northern District of West Virginia.

Lightbulb bag containing IP protected by shield
Viatris has already launched an appeal against the court's decision • Source: Shutterstock

Viatris Inc.’ visions of launching generic sitagliptin dihydrogen phosphate have taken yet another blow, after the US Court of Appeals for the Federal Circuit ruled that originator Merck & Co., Inc.’s patent remains valid. Sitagliptin is an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release), prescription drugs for type 2 diabetes.

The Federal Court ruling provides the three products with patent protection through to May 2027, which includes six months of pediatric exclusivity. While Viatris can still appeal the decision, it has ultimately been hailed as a boon for the originator, which had previously expected the drug to lose exclusivity in January 2023

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