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Belgium-based drug maker UCB has challenged Glenmark’s attempt to sell its generic version of Vimpat, used in the treatment of epilepsy, in the US.
The legal suit followed Glenmark’s filing in the US seeking regulatory approvals to sell its generically-similar version of the UCB drug.
The filing was a patent challenge, or a para IV filing. Confirming the development, Glenmark said that UCB filed a suit against Glenmark Generics Ltd and Glenmark Generics Inc on July 10, in the United States District Court (Delaware), seeking to prevent Glenmark from commercialising its generic product prior to the expiration of UCB’s patent in the US.
If Glenmark succeeds in its patent challenge, it would get a 180-day exclusivity for its products.
According to foreign media reports, UCB has challenged at least 13 other generic drug-makers over this drug. Industry estimates Vimpat tablets and solution to have annual US sales of about $353 million.
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