Natco Pharma seeks U.S. FDA nod for copy of Pfizer’s migraine drug, faces lawsuit 

Natco Pharma faces lawsuit from Pfizer over generic migraine drug, potential 180-day exclusivity for Rimegepant Sulfate tablet.

Natco Pharma has been named defendant in a lawsuit filed in the U.S. by Pfizer Inc and Pfizer Ireland Pharmaceuticals amid the abbreviated new drug application the Hyderabad-based drugmaker has submitted to the U.S. Food and Drug Administration seeking approval for a generic version of migraine drug Rimegepant Sulfate tablet Eq 75mg base strength.

“We believe our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances,” Natco said in a filing on Thursday. Natco shares closed 2.16% lower on the BSE at ₹998.10 apiece on Friday.

Rimegepant Sulfate tablets are marketed in the U.S by Pfizer Inc. under the brand name Nurtec ODT. The drug recorded sales of $908 million in the U.S. market for the year ended December 2023, Natco said citing Pfizer’s financial results presentation.

The drug 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, it said.

Natco, whose ANDA contains a paragraph IV certification, has been named as defendant in a lawsuit filed in the U.S. district court for the district of Delaware by Pfizer Inc. and Pfizer Ireland Pharmaceuticals.

Para IV certification pertains to the contention of generic drugmakers, at the time of submitting ANDA that their copy of the drug will not infringe the patent of the innovator.

According to U.S FDA, the first company or companies to submit an application that is determined by the regulator to be substantially complete upon submission and contains a paragraph IV certification to at least one of the patents listed in its Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.