Generic Lamivudine Has Arrived

January 22, 2012

Paul E. Sax, M.D.

Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.

An e-mail from a patient last week:

Just got refills. Epivir is now generic???  Refill is simply labeled Lamivudine Tablets by Aurobindo Pharma USA, Inc ... but made in India.  Should I be concerned about that???

I told John (not his real name) not to be concerned -- he is merely substituting the generic for the branded version, not switching from a fixed-dose combination or from a different drug (that drug being emtricitabine, or FTC).

With all the hoo-ha about generic atorvastatin, this one is much more under the radar. And the process to approval has not been smooth, as I wrote about here and here.

But generic lamivudine for HIV treatment is a watershed moment nonetheless, since it's really the first time there's a generic antiretroviral that we might actually consider prescribing. (Zidovudine and didanosine have been generic for years.)

It will be fascinating to see how this plays out, both here in the US and in other developed countries.

Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.

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This article was provided by NEJM Journal Watch. NEJM Journal Watch is a publication of the Massachusetts Medical Society.


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