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.
Sun Pharma launches imatinib mesylate in the US
Generics/News | Posted 26/02/2016 0 Post your comment
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.
Related article
Indian Supreme Court rejects Glivec patent
Reference
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.
Source: Sun Pharma
Research
Japan’s drug shortage crisis: challenges and policy solutions
Saudi FDA drug approvals and GMP inspections: trend analysis
Comments (0)
Post your comment