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Sun Pharmaceutical has inked a settlement with Novartis in the US in a case involving the latter’s blood cancer drug Gleevec.
Sun said one of its subsidiaries had settled with Novartis, leading to the dismissal of lawsuits opposing its submissions seeking to sell a generically similar version of Gleevec ( Imatinib mesylate ) tablets in the US. These tablets are indicated for the treatment of chronic myeloid leukaemia.
2016 launch possible Sun said that under the terms of the settlement, its subsidiary may launch a generic version of Gleevec in the US on February 1, 2016, but did not disclose details, citing a need for confidentiality. The agreement is also subject to customary regulatory approvals, it added. Sun’s subsidiary has tentative approval from the US Food and Drug Administration for its generic version of Gleevec, a drug estimated to gross $2 billion in the US in annual sales.
Novartis reaction Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India, said: “Patents are vital to the ability of innovative companies … to invest in high-risk research to advance breakthrough treatments… The agreement has been submitted for review to the US Federal Trade Commission and the US Department of Justice.”
As a result of the settlement, Novartis will permit Sun Pharma’s subsidiary to market a generic version of Gleevec in the US before certain Novartis patents expire in 2019. The basic compound patent for Gleevec expires in the US on July 4, 2015.
Last April, the Supreme Court had rejected Novartis’ patent application on Glivec (known as Gleevec in the US, Canada, Israel and South Africa) in India.
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