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Pharmaceuticals / Regulatory Affairs / Commercial Operations

Novartis Wins Five-Year Extension of U.S. Gilenya Patent

March 7, 2014

A five-year extension of the U.S. patent for its multiple sclerosis (MS) treatment Gilenya comes just in time for Novartis, as it faces generic competition and declining sales of two of its other blockbuster drugs. The U.S. patent, originally set to expire Feb. 18, will now extend to 2019.

While sales of Novartis’ Diovan (valsartan) and Zometa (zoledronic acid) shrank last year, global sales of Gilenya (fingolimod) grew to $1.9 billion in 2013, up 62 percent, Novartis says. Gilenya was approved by the FDA in September 2010.

Gilenya has proven itself in clinical studies, including a Phase III trial in which almost half of patients switched from Biogen Idec’s Avonex (interferon-beta-1a-IM) to Gilenya were found to be free of all four key areas of MS disease activity. The drug was also well-tolerated, Novartis says.

However, Gilenya’s safety was called into question last summer after a patient taking the drug developed progressive multifocal leukoencephalopathy, a rare and fatal brain infection. — Lena Freund

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