Sanofi | Torrent – Uroxatral Para IV Certification

Sanofi Torrent – Uroxatral Para IV Certification

Sanofi has filed a civil action for patent infringement in the US District Court for the Western District of Michigan in a move to prevent generic entry of Uroxatral tablet, generically alfuzosin hydrochloride by Indian drug manufacturer Torrent Pharma Inc. prior to the expiration of the Orange Book listed US Patent Nos. 4,661,491 (the ‘491 patent) and 6,149,940 (the ‘940 patent). Alfuzosin is an alpha-adrenergic blocker approved by the United States Food & Drug Administration for the treatment of Benign Prostatic Hyperplasia (BPH) and covered within the scope of the ‘491 patent till early 2011. Earlier Torrent filed an Abbreviated New Drug Application (ANDA) No. 79-054 with the FDA seeking approval to market generic alfuzosin hydrochloride extended release tablet in 10mg strength, alleging both the ‘491 and ‘940 patents are invalid and not infringed by the manufacture, use or sale of the proposed generic version of Sanofi’ Uroxatral tablet. In its complaint, Sanofi alleged that the submission of Torrent ANDA would constitutes infringement of the ‘491 and ‘940 patents under 35 USC § 271 (e) (2) (A). According to Sanofi Business Report 2006 Uroxatral is worth 353 million euros in worldwide sales.