Natco Pharma Limited announces submission of Abbreviated New Drug Application

NATCO Pharma Limited announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Rimegepant Sulfate tablet Eq 75mg base strength. Rimegepant is currently indicated for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults. Rimegepant Sulfate tablets are marketed in the United States (US) by Pfizer Inc. under the brand name NURTEC ODT®. Natco has been named as defendant in a lawsuit filed in the United States district court for the district of Delaware by Pfizer Inc. and Pfizer Ireland pharmaceuticals. We believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances. NURTEC ODT® has recorded sales of USD 908 million in the US market for the year ending December 2023, as per Pfizer financial results presentation.

The release as fetched from its publisher. natcopharma.co.in ↗