Nilotinib Patent Expiry Leaves Door Open For India Generics, Other Markets Could Face Longer Wait

Hetero Likely Planning India Generic

The expiry of Novartis’ nilotinib compound patent in July leaves the door open for Tasigna generics in India. Medicines Patent Pool sub-licensees like Hetero and Dr. Reddy’s are also free to launch their generics as the agreement doesn’t include the Indian market. However, MPP sub-licensee plans for other markets involve a tougher regulatory path

Nilotinib
A Generic To Tasigna Is Much Awaited • Source: Shutterstock

Medicines Patent Pool sub-licensed Novartis AG’s Tasigna (nilotinib), which generated $1.9bn in 2022 sales, to four companies in June – India-based Hetero, Dr. Reddy's Laboratories Ltd.'s and Aurobindo Pharma Limited subsidiary Eugia Specialities, along with Indonesian-based company BrightGene.

Novartis expects the sublicensees to “commence production in the coming months” a company spokesperson told Scrip, but the regulatory pathway...

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