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Glenmark launch: Only a short-term benefit

Offers generic anticonvulsant ahead of others in US


BL Research Bureau

With Glenmark receiving the final approval from the US Food and Drug Administration for marketing the first generic version of Trileptal (containing active ingredient Oxcarbazepine), this marks the first exclusive launch for the company in the US market.

Trileptal, which is indicated for treatment of seizures, reported sales of around $650 million for the year ended June 2007.

Launching the drug as soon as it got the FDA nod in three dosage strengths of 150 mg, 300 mg and 600 mg gives Glenmark a small edge over the Sun Pharma and Roxane with which it shares 180-day marketing exclusivity.

While Sun Pharma expects to launch the generic versions shortly, Roxane has launched its drug a day after Glenmark did. Sun, Glenmark and Roxane were amongst the first to file for the product.

Trileptal is Novartis’ blockbuster drug and the patent for Trileptal had expired in 2005. But the innovator company, Novartis, filed for a new patent for the product that is set to expire only in 2018.

Significantly, Glenmark and Sun Pharma were the only companies that were not taken to court by Novartis, even as patent related litigation with Roxane is ongoing in the US courts.

Assuming that the exclusivity will be shared by all the three first-to-file players, even if there is a significant price erosion of 50-70 per cent — this would still give Glenmark a one-time benefit. Besides, an exclusive product could assist Glenmark and Sun Pharma enhance their visibility with the trade in the US.

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