Novartis Gains Temporary Injunction from Generic Competition of MS Blockbuster Drug Gilenya
A federal district court judge has ruled in favor of Novartis in granting a temporary injunction barring generic competition for Novartis’ Gilenya (fingolimod hydrochloride), a multiple sclerosis drug. Global product sales of Gilenya in 2018 were $3.3 billion and $1.8 billion in the US.
In a ruling on June 21, 2019, US District Judge Leonard P. Stark of the US District Court for the District of Delaware granted Novartis a temporary injunction against several generic-drug companies to prohibit them from making or selling generic versions of Novartis’ Gilenya as patent litigation among the parties continues.
The defendant parties included Dr. Reddy’s Laboratories, Mylan Pharmaceuticals, Torrent Pharma and Aurobindo Pharma, among others. The temporary injunction bars them from making or selling a generic version of Gilenya in the United States until a final decision on the patent litigation is made.
In June 2018, Novartis filed suit against 25 generic pharmaceutical companies, alleging infringement of the patent relating to uses of an S1P receptor modulator for the treatment or prevention of neo-angiogenesis associated with demyelinating diseases such as multiple sclerosis and related dosing regimens.