Glenmark Pharmaceuticals to market epilepsy drug oxcarbazepine in the US
10 Oct 2007
Glenmark says it was one of the first ANDA applicants to submit a Paragraph IV certification to the ''525 patent''. With this approval it has been awarded a 180-day shared generic drug exclusivity for these strengths.
Trileptal is a widely used medication to treat epilepsy that has FDA approval.
According to IMS Health, oxcarbazepine sales were approximately $643 million, for the 12-month period ending 30 June 2007.
With this approval, Glenmark Pharmaceuticals now has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process / launch.
The
US FDA has also granted its final approval for Sun Pharmaceutical Industries''
abbreviated new drug application (ANDA) to market its generic version of Novartis
Trileptal, oxcarbazepine tablets.(See:US
FDA approves Sun Pharmaceutical'' version of Novartis''s Trileptal tablets for US
sales)
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