The FDA has given a green light to several generics of Sanofi and Bristol-Myers Squibb's (BMS) blockbuster antiplatelet drug Plavix, with the first copycat version already starting to ship.
The patent on Plavix (clopidogrel) expired yesterday (May 17) in the US, opening up a market worth $6.67n in 2011 and accounting for the bulk of the product's $7bn in global sales last year, shared between Sanofi and BMS. The product has made around $9bn a year at peak.
Sales outside the US have been in steep decline of late as patents started to expire in other countries, and analysts expect a dramatic decline in overall revenues for the brand once generics become widely available in the US.
Plavix is approved to treat patients who have had a recent heart attack or a recent stroke, or who have peripheral artery disease.
Mylan said it has already started shipping the 75mg and 300mg doses of the drug, and that it has 180-day exclusivity for the latter under the US first-to-file provisions.
Canadian firm Apotex was originally the first to file but lost its exclusivity after launching a generic in 2006 that was subsequently ordered off the market after a legal challenge.
Other generic drugmakers given the go-ahead include Teva, Aurobindo Pharma, Roxane Labs, Torrent Pharma, Dr Reddy's Labs and Gate Pharma.
Sanofi and BMS are weathering the impact of two major patent expiries each, with BMS set to lose US patent protection for $1.2bn antihypertensive brand Avapro (irbesartan) this year and Sanofi already dealing with around €2bn in lost sales after the end of exclusivity for anticoagulant Lovenox (enoxaparin).
"For people who must manage chronic health conditions, having effective and affordable treatment options is important," commented Keith Webber, deputy director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research.
"The generic products approved today will expand those options for patients," he added.
In an attempt to limit the impact of generic competition to the franchise, Sanofi and BMS have launched a loyalty programme - called Plavix Choice - which offers discounts to patients who want to continue to use the brandname drug.