Dr Reddys files ANDA for Sumatriptan

Dr. Reddy's Laboratories has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration 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.

Dr. Reddy's notified the same to the patent holder GlaxoSmithKline (GSK) as per the mandatory requirement upon which the latter filed a lawsuit against the company in the Southern District of New York alleging patent infringement on the '845 patent.

Sumatriptan Succinate is the generic version of GSK's Imitrex and is indicated for the treatment of migraine. The brand had annual sales in the US of approximately $ 773 million as per IMS 2002 data.

While GlaxoSmithKline's last patent on the drug expires only in 2016, the '845 patent, pertaining to which it filed patent infringement case against Dr. Reddy's, will expire in 2008.

With the latest disclosure, Dr. Reddy's US product pipeline currently pending approval from US FDA comprises 28 Andas. Of these 21 were submitted under Paragraph IV ( patent challenge in nature) and 8 of them are said to be first-to-file, according to a press release here.