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    • Aurobindo Pharma, Dr...

    Aurobindo Pharma, Dr Reddys, Torrent Pharma, Mylan cannot sell generic Gilenya patented by Novartis

    Medical Dialogues BureauBy Medical Dialogues BureauPublished On 2019-06-26T16:21:30+05:30  |  Updated On 26 Jun 2019 10:51 AM GMT
    Aurobindo Pharma, Dr Reddys, Torrent Pharma, Mylan cannot sell generic Gilenya patented by Novartis

    Novartis had asked for a preliminary injunction to halt generics makers including Dr Reddy's Laboratories (Dr Reddys), Mylan Pharmaceuticals, Torrent Pharma and Aurobindo Pharma, among others, from making or selling a Gilenya copy in the United States until a final decision on a Novartis patent for the medicine.


    ZURICH: Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of the Swiss drugmaker's top-selling multiple sclerosis medicine Gilenya in the United States, at least until a patent dispute is resolved.


    Novartis had asked for a preliminary injunction to halt generics makers including Dr Reddy's Laboratories, Mylan Pharmaceuticals, Torrent Pharma and Aurobindo Pharma, among others, from making or selling a Gilenya copy in the United States until a final decision on a Novartis patent for the medicine.


    The judge said letting generics makers sell their versions before the patent dispute was decided would damage the Swiss drugmaker more than those wanting a piece of Gilenya's market.


    Read Also: Novartis, Glenmark enter partnership to commercialize, distribute respiratory drugs Seebri, Onbrize, Ultibro


    "Defendants stand to lose the opportunity to earn ... $50 million collectively by not being able to compete over approximately the next year, whereas Novartis will irreparably lose a market in which they sell approximately $1.8 billion of drugs each year," U.S. District Judge Leonard P. Stark wrote in a nine-page opinion published on Monday.


    "To me, that balance clearly favours Novartis."


    Worldwide, Gilenya revenue totalled $3.3 billion in 2018, making the decade-old MS medicine Novartis's top-selling medicine. While a patent term extension expires in 2019, Novartis is arguing a patent on how the drug is dosed that is slated to expire in 2027 should extend its exclusivity.


    Judge Stark's decision ends uncertainty over whether the generics makers would start selling their Gilenya versions in the United States before the patent case was resolved.


    A trial on the patent case is still pending.


    Read Also: Novartis MS drug Mayzent price out of line with benefit; says US group


    Gilenya has a list price of $95,594 annually in the United States. While consumers would benefit from lower prices likely to accompany generics, Stark said Novartis has a good chance of succeeding in its claims.


    "Novartis has met its burden to demonstrate a likelihood of success on the merits," Stark, based in Delaware, wrote. "The public has an interest in protecting valid patent rights and in maintaining incentives for the massive investments required for drug development."

    Aurobindo Pharma Dr Reddy's Dr Reddy's Laboratories Dr Reddy's Labs generic gilenya generics GILENYA Gilenya reprieve MS drug multiple sclerosis Mylan Novartis patent issue patent litigation Torrent Pharma United States 
    Source : Reuters

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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