Lupin sends notice to Oscient over cholesterol generic

MUMBAI: Indian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory approval for a generic version of Oscient���s cholesterol drug, Antara. Oscient received a notice to this effect on Wednesday, its official website said.

The notice stated that Lupin had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (USFDA) to launch a generic version of Antara in the market. The notice alleges that US Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for Antara, is invalid and will not be infringed by Lupin's manufacture, use or sale of the product. US Patent No 7,101,574 will be expired in 2020, the website stated.

Lupin is claiming that a patent covering the treatment for high cholesterol is invalid and will not be infringed by the copycat version, Oscient said in a release.

This was part of a Para 4 filing that Lupin made.

Oscient and Ethypharm have 45 days to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision in its favour, whichever may occur earlier. The companies are currently evaluating the notice and intend to pursue all available legal and regulatory options in defence of Antara, including enforcement of their intellectual property rights, a company release said.

Oscient is a commercial-stage pharma company marketing two FDA-approved products in the US ��� Antara and Factive, a fluoroquinolone antibiotic. Lupin���s main therapy areas include cephalosporins, cardiovascular, anti-asthma, non-steroidal anti-inflammatory, anti-Tuberculosis and diabetic drugs.