India rejects J&J's application to extend monopoly on anti-TB drug bedaquiline

The Indian Patent Office has rejected US healthcare giant Johnson & Johnson's (NYSE: JNJ) secondary patent on the tuberculosis (TB) med bedaquiline. The landmark decision has prevented the drug from being locked in a patent for another four years after its primary patent expires in July.

The primary patent for bedaquiline, marketed under the brand name Sirturo, and "its salts, isomers, and enantiomers" expires on July 18, 2023. However, the drug company filed a secondary patent application for the fumerate salt and a wetting agent containing the same active pharmaceutical ingredient. This would have extended the monopoly on the drug for over four years till December 2027.

The decision will lead to the introduction of generic versions of the drug in the domestic market at a cost of approximately 80% less than the $400 for a six-month course of treatment of the J&J brand.