Indian Pharma cos get green signal to distribute generic Bedaquiline in low, middle income countries

"The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of SIRTURO without a concern that the Company will enforce its bedaquiline patents, provided the generic versions of SIRTURO produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries," JnJ informed ET .

The lapse of a patent on Bedaquiline has set the stage for generic pharmaceutical producers, including Lupin and Macleods, to commence supplying the drug. This development helps to make the essential anti-TB drug more affordable and accessible.

Previously, J&J sought to prolong its patent hold in India by an additional four years through the filing of a secondary patent. Yet, in April, India's patent office dismissed this secondary patent of the drug, which would have extended the drug's monopoly past the expiration of the primary patent in July this year. J&J had initially filed a patent in 2008 for the Fumarate salt of Bedaquiline, aiming to extend its patent until 2027. It was under review by the patent office.

This strategy, known as "patent evergreening," is often utilized by companies to maintain elevated pricing by delaying the introduction of more affordable generic versions into the market.