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Sun Pharma launches imatinib mesylate in the US Posted 26/02/2016

On 1 February 2016, Sun Pharmaceutical Industries (Sun Pharma) launched imatinib mesylate in the US, a generic version of Gleevec (imatinib mesylate) developed by Novartis. Sun Pharma received final approval for imatinib mesylate from the US Food and Drug Administration (FDA) in December 2015, and was granted 180 days of marketing exclusivity from the time of its launch.

The news of the launch follows the settlement of patent litigation between Sun Pharma and Novartis back in May 2014. The terms of the settlement allowed Sun Pharma to launch its generic version of imatinib in the US on 1 February 2016 [1].

Imatinib mesylate is a kinase inhibitor that FDA has approved to treat adults with chronic myeloid leukaemia with Philadelphia chromosomes, as well as several other cancers.

Sun Pharma also announced the launch of the ‘Sun Pharma Imatinib Mesylate Savings Card’ programme, a co-payment card for privately insured patients. The programme aims to deliver greater access to the drug for patients with private insurance but for whom out-of-pocket expenses may exceed an affordable amount.

An exclusive patient information website has been launched (www.imatinibrx.com), and a hub service has been established for patients to call a free phone number (+1 844 502 5950) to speak to a trained healthcare professional about the drug. Sun Pharma will be supplying its Imatinib Mesylate Savings Cards to over 4,500 oncologists. Qualifying patients can also obtain imatinib mesylate at no cost through its ‘Patient Assistance Program’.

The launch of imatinib mesylate comes at a time when Novartis is experiencing a large number of patent expirations, widely exposing it to generics competition. Imatinib mesylate has been approved for a number of indications, making it a formidable competitor to Gleevec. A downturn in sales of Gleevec is anticipated after expiry of the 6-month exclusivity period if other generics are ready for launch.

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1.    GaBI Online - Generics and Biosimilars Initiative. Novartis settles Gleevec lawsuit with Sun Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: www.gabionline.net/Generics/News/Novartis-settles-Gleevec-lawsuit-with-Sun-Pharma  

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Source: Sun Pharma

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