Novartis to maintain Gleevec exclusivity until early 2016
- After a year of patent-related litigation, Novartis and Sun Pharma have reached a settlement in which Novartis will maintain exclusivity over Gleevec (imatanib mesylate) until February 2016
- Sun attempted to enter the market with generic Gleevec (imatanib mesylate) early and was turned down by the Indian Supreme Court.
- Gleevec, which had $2 billion in sales in the U.S. in 2013 , will be marketed under the name Glivec by Sun Pharma in the U.S. once the patent expires.
In August 2007, Sun Pharma filed a paragraph IV ANDA for imatanib mesylate (brand name: Gleevec), indicated for the treatment of chronic myeloid leukemia, challenging Novartis’s patent integrity and exclusivity. Subsequently claiming that Novartis had failed to file an infringement suit during the legal 45-day window, Sun set out to start marketing generic Gleevec tablets (under the name Glivec), hoping to enjoy the 180-day period of exclusivity granted under a successful Paragraph IV filing.
Novartis has successfully defended the integrity of its patents, which will enable the company to maintain exclusivity through early 2016. Though the patent for the original compound expires in July 2015, the company has other patents on various forms of Gleevec, including the pediatric formulation, as well as a crystal form patent, which expires in 2019. Regardless, Sun is expected to introduce a generic version of Gleevec in February 2016. Analysts predict $160 million in gross revenues in the first six months.
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