Natco Pharma seeks U.S. FDA nod for copy of Pfizer’s migraine drug, faces lawsuit
The Hindu
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.
RBI plans ₹1 lakh crore OMO in December to boost liquidity amid upcoming tax payments, ensuring stability in the banking system.
IndiGo faces ongoing flight delays and cancellations due to technology issues, weather, and new crew rostering rules.
Stock markets experience volatility as investors await RBI's monetary policy amid foreign fund outflows and mixed global trends.
ED attaches assets worth ₹1,120 crore in Anil Ambani's Reliance Group case, totaling ₹10,000 crore amid money laundering probe.
Rupee rises 20 paise to 89.69 against the dollar as investors await RBI's monetary policy decision amidst market pressures.
Just nine Fugitive Economic Offenders (FEOs) owed Indian banks over ₹58,000 crore in principal and interest. To date, banks have recovered just over ₹19,000 crore — roughly 33% of the total dues.
Commerce Minister Piyush Goyal urges Indian businesses to seize opportunities in Russia's market, addressing talent shortages and trade demands.
Premiumisation is driving the growth in beauty and personal care industry in India and this segment is growing faster than the products made for the masses, industry executives said at Cosmoprof India 2025, a beauty & personal care industry event currently underway in Mumbai.
Scaling Artificial Intelligence(AI) at the speed at which consultants project is not possible by the laws of physics and may not be environmentally sustainable, said Tanvir Khan, who is the Executive Vice President and Chief Operating Officer of NTT DATA North America, part of the Japanese technology services and data centre company NTT Data, in an interview with The Hindu.
The Rupee appreciated by 19 paise to close at 89.96 against the U.S. dollar amid weak dollar index support.
India aims to expand its tea exports to China, highlighting diverse varieties like Darjeeling and Masala at a recent buyer-seller meet.
Stock markets rebound after four days of decline as Sensex rises 158 points, driven by tech and IT shares.
India reduces Russian oil imports by 38% in October 2025, marking the sharpest decline in value and volume yet.