CAFC upholds the the validity of the Gilenya (fingolimod) dosing regimen patent

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The United States Court of Appeals for the Federal Circuit (CAFC) has upheld the validity of the Gilenya (fingolimod) dosing regimen patent, according to Novartis.

Novartis said on Tuesday that the United States Court of Appeals for the Federal Circuit (CAFC) upheld the validity of US Patent No. 9,187,405 for a Gilenya dosage regimen.

The United States Federal District Court for the District of Delaware issued a positive judgement in the Gilenya patent case in August 2020, and HEC Pharma was awarded a permanent injunction until the ‘405 patent expires in December 2027. (including paediatric exclusivity). The sole surviving Abbreviated New Drug Application (ANDA) filer challenging the patent was HEC Pharma. This judgement upholds the patent’s validity and enables the injunction to stay in effect.

Novartis had already reached settlement agreements with a number of ANDA filers. If authorised by the FDA, those ANDA filers will not be able to launch a generic version of Gilenya before an agreed-upon date that is before the dosage regimen patent expires in December 2027. The settlement agreement’s prospective generic entry date and other terms are kept under wraps. Novartis has confirmed that no generic versions of Gilenya will be available in the United States for at least the next two years as a result of this decision.

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