Glenmark receives USFDA nod for generic drugs

PTI New Delhi | Updated on March 12, 2018 Published on December 23, 2010

Glenmark Pharmaceuticals said on Thursday that it has received the US health regulator’s approval to market three generic products in the American market.

Glenmark Generics Inc, the US based subsidiary of the company has received final approval from the US Food and Drug Administration (USFDA) for two products —— Indomethacin capsules in strengths of 25 mg and 50 mg and Sulfamethoxazole and Trimethoprim tablets in double and single strengths, Glenmark said in a statement.

“These products are currently available and the company has commenced shipping from their New Jersey facility,” the company said.

According to IMS Health, total sales achieved for Indomethacin in the US market for the 12 month period ending September 2010 were USD 20 million. Sales of Sulfamethoxazole and Trimethoprim stood at $ 31 million for the same period in the US market.

While Indomethacin is used in treating arthritis, Sufamethoxazole and Trimethoprim tablets are indicated for urinary tract infections.

Apart from two final approvals, the company received a tentative approval from USFDA for Eszopiclone, the generic version of Sepracor’s Lunesta, which according to IMS Health achieved annual sales of $ 760 million for the 12-month period ending September, 2010. Eszopiclone is used to treat insomnia.

Earlier this year, Glenmark had entered into a settlement and licence agreement with Sepracor to resolve a United States patent infringement suit related to its filing an abrreviatd new drug approval (ANDA) for Eszopiclone with the USFDA.

Under the terms of this agreement, Glenmark would be permitted to launch its generic product on the later of November 30, 2013, which is 2.5 months prior to the expiry of Sepracor patent or May 30, 2014 if Sepracor obtains pediatric exclusivity for Lunesta.

“The settlement and licence agreement and Consent Judgment and Order would also permit Glenmark to launch its generic product earlier under certain circumstances,” the company said.

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Published on December 23, 2010
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