Global Insight Perspective | |
Significance | Two drug litigation settlements from Indian pharma firms were announced involving patented drugs by U.K. firm GlaxoSmithKline (GSK) and Swiss company Novartis. |
Implications | Ranbaxy's decision to settle with GSK over Imitrex was expected in line with earlier arrangements by the U.K. pharma major, highlighting the Indian firm's entry into an already crowded generics market. |
Outlook | The arrangement signifies a greater resolve to exploring opportunities relating to patent infringement litigations gaining on Big Pharma's strategy to keep generic competition at bay through settlements, including authorised generics. |
Indian drug-maker Ranbaxy Laboratories has announced that it had settled "all matters relating to possible patent litigation" with GSK on the latter's Imitrex (sumatriptan succinate tablets). According to the Indian firm, the terms of the settlement will allow Ranbaxy to distribute a generic version of Imitrex in the United States as of December. Ranbaxy seeks to sell the product in strengths of 25 mg, 50 mg, and 100 mg. Branded annual sales of Imitrex are at US$985 million.
Rival Indian firm Dr Reddy's Laboratories has announced a similar arrangement with Swiss pharma major Novartis relating to the latter's Alzheimer's drug, Exelon (rivastigmine tartrate). According to the Indian firm, it will not launch its generic version "until sometime before the expiry of the product". Dr Reddy's said it had first received a U.S. FDA approval for its generic rivastigmine in October 2007. The companies have, however, kept the expected launch date and other financial details of the deal under wraps. Annual brand sales of rivastigmine in the United States are at US$199 million.
Outlook and Implications
Ranbaxy's arrangement with GSK is unsurprisingly given the U.K. major's previous settlements with other generic producers of Imitrex, including Cobalt Laboratories (a U.S. subsidiary of Arrow Pharmaceuticals), Dr Reddy's, and U.S. firms Spectrum Pharmaceuticals and Par Pharmaceuticals. Dr Reddy's has so far emerged with the best deal with a potential marketing exclusivity period, and is expected to start marketing its generic version of Imitrex in the fourth quarter of 2008. In fact, despite receiving tentative approvals from the FDA in August 2005, Ranbaxy's settlement comes more than a year after GSK initiated settlement arrangements in a bid to delay generic competition for Imitrex for as long as possible. According to the FDA's Orange Book (including paediatric exclusivity), Imitrex's patent runs until 6 February 2009. The development may generate value for Ranbaxy, though this will not be reflected until the first quarter of 2009. It does signal the company's increasing resolve to explore opportunities while dealing with patent litigations. Moreover, it is known that Ranbaxy is pursuing a potential settlement for sleep disorder drug Provigil (modafinil) with U.S. firm Cephalon.
Dr Reddy's and Ranbaxy's moves highlight a general trend in the global pharmaceutical industry wherein Big Pharma firms are seen to be increasingly turning to authorised generics and product settlements to ensure the exclusivity of their patented products. The rising number of out-of-court settlements involving Indian firms is widely documented, as well as spate of settlements akin to Lupin's (India) arrangement with Astellas (Japan) over Omnicef (cefdinir).
Related Articles
- India: 5 July 2007: Firms in India Seek to Turn Litigation Woes into Opportunities
- India - United Kingdom: 11 October 2006: Dr Reddy's Settles Imitrex Patent Dispute with GSK