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.
"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

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

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.

Read also: Natco Pharma reports over 3-fold rise in net profit at Rs 212.7 crore in Q3

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News