Migraine drug: Natco Pharma submits application for generic version of Rimegepant Sulfate tablet with USFDA

Published On 2024-05-31 05:30 GMT | Update On 2024-05-31 05:30 GMT

Telangana: Natco Pharma Limited has announced the submission of an 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.

Migraine is a neurological condition characterized by recurrent headaches that are moderate to severe in intensity.

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.

Read also: Natco Pharma invests around US$ 2 million in Cellogen Therapeutics

"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," the Company stated.

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

Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Migraine drug: Natco Pharma submits application for generic version of Rimegepant Sulfate tablet with USFDA

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