NURTEC ODT — FDA application NDA212728

Application NDA212728 · type NDA · FDA status: approved · original approval 2020-02-27

Listed sponsor: PFIZER · PFE company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	NURTEC ODT	RIMEGEPANT SULFATE	TABLET, ORALLY DISINTEGRATING	ORAL	EQ 75MG BASE	Prescription	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 8759372	001	listed patent expiry date: 2033-02-25	drug substance, drug product
Patent 8314117	001	listed patent expiry date: 2034-02-27	drug substance, drug product, U-2718
Patent 8314117	001	listed patent expiry date: 2034-02-27	drug substance, drug product, U-3142
Patent 11083724	001	listed patent expiry date: 2039-03-25	drug product, U-2718
Patent 11083724	001	listed patent expiry date: 2039-03-25	drug product, U-3142

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

RIMEGEPANT SULFATE · UNII 1383NM3Q0H · lmmol compound SOGUOEZRYKUOHR-CQZKMDJHSA-N · CHEMBL2364629

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.