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Hyderabad, Dec 31: Dr Reddy’s Laboratories Ltd (DRL) has announced that the company has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Sumatriptan Succinate oral tablets, equivalent to 25 mg, 50 mg and 100 mg base with a Paragraph IV certification on four of the five Orange Book patents listed for the drug.
In this regard, the company has notified GlaxoSmithKline, upon which the latter filed a lawsuit against the company in the US District Court for the Southern District of New York alleging patent infringement on the ’845 patent, the company stated in a release. Sumatriptan Succinate is the generic version of GlaxoSmithKline’s Imitrex and is indicated for the treatment of migraine. The brand has annual sales in the US of approximately $773 million, the release added.
Dr Reddy’s Laboratories expects to file about 15-18 ANDAs by the end of current fiscal. The company has already filed about five ANDAs during the first two quarters, out of which four ANDAs are patent challenged, according to company officials.
Till last quarter, September 30, 2003, Dr Reddy’s has filed about 39 ANDAs out of which 27 are pending approvals and the remaining 12 ANDAs have been approved and being marketed. Out of the 27 pending at the US FDA office, 20 are patent challenged, added the officials.
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