HIV and ID Observations

In the recent post on the approval of generic Combivir — and the lack of availability of generic Epivir (lamivudine, 3TC), which was both anticipated and likely to be more useful — I speculated there were several possible causes of this surprising turn of events.

But ultimately I concluded, “In sum, the real reason there’s no generic 3TC remains a mystery.”

Last week, however, I received a fascinating email from an industry representative, who has asked that I summarize the turn of events from their perspective:

• The Epivir patent in the US expired in May 2010.
• A generic company was granted exclusive rights to market a generic in the US for 6 months.  (This is part of patent law.)
• The particular company that was granted exclusivity was not been able to manufacture a product that has met approvability standards by the FDA.
• During the period of exclusivity, furthermore, no other company can market a generic either — again, patent law in action.

Mystery solved — and thank you for the clarification.

But I hasten to add that this information was not widely known by HIV/ID specialists, and furthermore not easy to find.  One of my colleagues has likened reading rulings on patent law for generics akin to learning English as a second language, a very apt analogy.