Plavix loses US patent protection
pharmafile | May 18, 2012 | News story | Sales and Marketing | BMS, FDA, Lipitor, Pfizer, Plavix, Sanofi
Sanofi and Bristol-Myers Squibb’s blood thinner Plavix has lost its patent protection in the US.
The drug, which made $6.6 billion in US sales last year, will now compete with generic copies from firms such as Teva and Dr Reddy’s after the FDA approved their use yesterday.
Plavix (clopidogrel), once the second biggest selling drug in the world, helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
It is licensed in patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease).
Both Sanofi and BMS said in a recent sales report that they expected “a rapid, precipitous and material decline” in revenue from the drug now that generic copies are available.
Keith Webber, deputy director of the office of pharmaceutical science in the FDA’s centre for drug evaluation and research, said: “For people who must manage chronic health conditions, having effective and affordable treatment options is important.
“The generic products approved [yesterday] will expand those options for patients.”
The FDA has approved generic forms of high dose (300mg) clopidogrel for: Dr Reddy’s Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva.
A lower dose 75mg version of the drug has also been approved for Apotex, Aurobindo Pharma, Roxane Laboratories, and Sun Pharma, as well as for Teva and Mylan.
When Pfizer’s Lipitor went off patent in the US last year the US giant struck a deal with Ranbaxy, giving the firm a 180-day exclusivity on its generics for the drug.
But Sanofi and BMS have no such deal in place for Plavix, and will lose a major slice of market share swiftly given the high level of generic competition.
Plavix has patent protection in Europe until 2013, but a loophole in the drug’s patent has meant that generic forms of the drug have been available on the continent since 2009
Ben Adams
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