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

Hetero Likely Planning India Generic

 
• By Vibha Ravi

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 to marketing generic nilotinib in the 44 territories covered by...

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