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Regulatory Focus™ > News Articles > FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent

FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent

Posted 18 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi's blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the latest product to go off the so-called "patent cliff."

Many drugs are scheduled to lose their patent protection in the coming two years, marking huge potential losses to the bottom lines of numerous companies. Both Sanofi and BMS said they expect a "rapid, precipitous and material decline" in revenue from the drug, reports In Pharm.

While most products are subject to initial competition by a single competitor under a law meant to spur competition by granting time-limited (six month) exclusivity to the first company to apply to market a generic product, Plavix will be subject to a huge amount of competition at once.

Med Page Today reports Apotex wound up forfeiting its generic exclusivity period after being found guilty of infringing on BMS and Sanofi's patent.

"As a result, there is no exclusivity period for generic clopidogrel-hence the simultaneous approvals given to the [nine] firms," adds Med Page Today.

"Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300 milligram (mg) clopidogrel," announced FDA. "Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel."

Read more:

FDA - FDA approves generic versions of blood thinner Plavix

Med Page Today - Plavix Generic Competitors Get Green Light

InPharm - Plavix loses US patent protection


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