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Viatris Loses US Challenge To Januvia And Janumet Patents

US Firm May Appeal; Has Appealed Negative USPTO Decision

Executive Summary

Viatris’ attempts to deliver US generic versions of sitagliptin and sitagliptin/metformin ahead of patent expiry has failed for now, with an unfavorable judgment from a district court in West Virginia. More than 20 ANDA sponsors have opted to settle litigation with originator Merck.

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The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

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