After Pushback, J&J Allows Generics of Its TB Drug

Bedaquiline was approved by the FDA in 2012, and its primary patent — which covers its composition — was set to expire on July 18, according to S. Sean Tu, PhD, JD, professor of law at West Virginia University in Morgantown. But the company also has a secondary patent that covers its formulation — a strategy described as “patent evergreening” — that could extend its monopoly even longer.

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