A U.S. district court ruling invalidated four patents on Teva's multiple sclerosis therapy, Copaxone, meaning a generic version of the 40mg formulation could be on the market as soon as this month.
The ruling put a stop Teva’s strategy of switching patients from the original 20mg once-daily version of Copaxone to the newer 40mg, thrice-weekly version.
Copaxone generates a fifth of Teva’s $20 billion in annual sales.
Novartis and partner Momenta have a generic version of the 40mg dose under FDA review. Mylan also has a generic of the thrice-weekly version awaiting U.S. regulatory approval. Dr. Reddy's Laboratories and Amneal Pharmaceuticals also have 40mg products.
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