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July 10, 2013

Generic ClopidogrelTime to Substitute?

Author Affiliations
  • 1Duke University Medical Center, Durham, North Carolina
JAMA. 2013;310(2):145-146. doi:10.1001/jama.2013.7155

Another blockbuster generic drug entered the US marketplace on May 17, 2012, following the expiration of Sanofi and Bristol-Myers Squibb exclusivity for Plavix. Generic clopidogrel bisulfate, approved for marketing in the United States by 12 companies at present, immediately reduced the cost of the popular drug. The generic formulation is expected to take over the nonaspirin antiplatelet market previously dominated by Plavix—formerly the world’s second best-selling drug, with reported sales of $9.8 billion in 2011.1 Patients and clinicians may assume the generic formulations of clopidogrel are identical to the brand name product. Many may be unaware that a transition has taken place, with automatic generic substitution now common. Although generic clopidogrel may over time demonstrate efficacy and safety equal to the innovator drug, few data are available to guide clinicians in deciding when generic substitution is appropriate.

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