Novartis keeps generics away from its Gilenya against multiple sclerosis

4 January 20222 years ago babelfish

The exclusivity of the Novartis drug Gilenya against multiple sclerosis confirmed. Chinese pharmaceutical manufacturer Hec Pharma (and beyond) wanted to produce a generic equivalent. All the details

Swiss Novartis' multiple sclerosis drug Gilenya will be unrivaled – at least for the moment. A US Court of Appeal confirmed the drug's exclusivity .

THE DISPUTE WITH HEC PHARMA

Already in August 2020, Radiocor recalls, "a federal court in Delaware had blocked, until the patent expired in 2027, the Chinese pharmaceutical manufacturer Hec Pharma who wanted to sell a generic version of the drug".

Hec Pharma, in fact, had requested the approval of the generic from the Food and Drug Administration (Fda).

Novartis, Le Figaro said , had agreed with several other manufacturers of generic drugs, which however will not be able to produce a generic version until an agreed date which, according to the pharmaceutical company, is one of the confidential information in the terms of the agreement.

THE SENTENCE

Now the Court of Appeal has rejected the arguments of Hec Pharma, which claimed that the patent lacked an adequate written description, and confirmed the exclusivity of the drug to Novartis.

"This decision confirms the validity of the patent and allows the injunction [against Hec Pharma, ed ] to remain in effect," Novartis said in a statement , adding that it does not expect generic versions of Gilenya on the US market for at least the next two. years.

HOW MUCH GILENYA IS WORTH

According to a company report quoted by Reuters , Novartis has earned more than $ 3 billion from the sales of Gilenya last year, making it the second best-selling drug in the company . Gilenya is a prescription drug used to treat relapsing forms of multiple sclerosis.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/novartis-tiene-alla-larga-i-generici-dal-suo-gilenya-contro-la-sclerosi-multipla/ on Tue, 04 Jan 2022 10:50:32 +0000.