Novartis's Gilenya Dosage Regimen Patent Upheld in US Court Decision
August 18 2020 - 03:23AM
Dow Jones News
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 cecilia.butini@wsj.com
(END) Dow Jones Newswires
August 18, 2020 03:08 ET (07:08 GMT)
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