Novartis's Gilenya Dosage Regimen Patent Upheld in US Court Decision

By Cecilia Butini

Novartis AG said late Monday that a U.S. district court upheld the validity of a company patent on Gilenya, a treatment for relapsing-remitting multiple sclerosis, protecting it from competition in the U.S.

The dosage regimen patent and its exclusivity for pediatric use is set to expire on December 25, 2027, the Swiss pharmaceutical company said.

The decision by the district court in Delaware means the manufacture of fingolimod, the generic version made by Chinese pharmaceutical company HEC Pharm Co. and its U.S. subsidiary, infringe Novartis's patent. The decision continues the company's injunction against the marketing and sale of fingolimod and other generics, which was granted in 2019, the company said.

Gilenya generated $3.2 billion in global sales for Novartis in 2019.

Novartis had previously settled litigation with manufacturers who filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration, it said. Under those settlements, companies will be able to market a generic version of Gilenya prior to the patent's expiration.

Write to Cecilia Butini at [e-mail]

(END) Dow Jones Newswires

August 18, 2020 03:08 ET (07:08 GMT)

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