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Glenmark Pharmaceuticals Ltd
has received final US Food and Drug Administration approval for the marketing
the first generic version of Trileptal (oxcarbazepine). The approval is for marketing
Oxcarbazapine tablets in three strengths - 150 mg, 300 mg and 600 mg. 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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