gibreel ferishta
Indian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory appr
oval 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 pharma drugs generics Oscient Antara
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