Novartis has dismissed lawsuits filed in the US against a subsidiary of Sun Pharma due to the company’s submission of an abbreviated new drug application (ANDA) for a generic version of imatinib mesylate tablets.

Imatinib was originally approved for the treatment of chronic myeloid leukaemia, but its indications have been extended to include gastrointestinal stromal tumours.

Under the terms of the settlement agreement, Sun Pharma’s subsidiary may launch its generic version of imatinib in the US on 1 February 2016. In the US, the patent protecting the active ingredient will expire on 4 January 2015. However, the patent protecting the beta crystal form of the active ingredient will only expire on 23 May 2019. While the patent for the treatment of gastrointestinal stromal tumours extends until December 2021.

Sun Pharma’s subsidiary has already gained tentative approval from the US Food and Drug Administration (FDA) for its ANDA for a generic version of imatinib. According to IMS Health data, Gleevec had annual sales of approximately US$2 billion in the US.

In Europe, the basic patent on (EP0564409) Glivec (imatinib mesylate), as it is called in Europe, expired in March 2013. The Supplementary Protection Certificate (SPC) should protect Glivec in European Union countries against competition from generics until the middle of June 2016. The European Medicines Agency (EMA), however, has already approved four generic versions of imatinib.

Novartis also fought a seven-year unsuccessful and controversial battle to patent Glivec in India [1].

Novartis is looking to overcome the upcoming loss of patent exclusivity on Gleevec by switching patients with chronic myeloid leukaemia to its newer therapy Tasigna (nilotinib).

Note: Imatinib (INN) is marketed by Novartis as Gleevec in Canada, South Africa and the USA; or Glivec in Australia, Europe and Latin America.

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Reference

1.   GaBI Online - Generics and Biosimilars Initiative. Indian Supreme Court rejects Glivec patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Policies-Legislation/Indian-Supreme-Court-rejects-Glivec-patent

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