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NURTEC ODT Drug Patent Profile

Which patents cover Nurtec Odt, and what generic alternatives are available?

Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and five patent family members in thirty-six countries.

The generic ingredient in NURTEC ODT is rimegepant sulfate. One supplier is listed for this compound. Additional details are available on the rimegepant sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nurtec Odt

Nurtec Odt was eligible for patent challenges on February 27, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NURTEC ODT

International Patents:	105
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Drug Prices:	Drug price information for NURTEC ODT
What excipients (inactive ingredients) are in NURTEC ODT?	NURTEC ODT excipients list
DailyMed Link:	NURTEC ODT at DailyMed

See drug prices for NURTEC ODT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NURTEC ODT

NDA:

212728

Dosage:

TABLET, ORALLY DISINTEGRATING;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NURTEC ODT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Antonios Likourezos	Phase 4
Weill Medical College of Cornell University	Phase 2
Biohaven Pharmaceuticals, Inc.	Phase 2

See all NURTEC ODT clinical trials

Pharmacology for NURTEC ODT

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NURTEC ODT

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for NURTEC ODT

NURTEC ODT is protected by five US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NURTEC ODT

FDA Regulatory Exclusivity protecting NURTEC ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y

International Patents for NURTEC ODT

When does loss-of-exclusivity occur for NURTEC ODT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NURTEC ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3094693	RIMEGEPANT POUR TROUBLES LIES AU CGRP (RIMEGEPANT FOR CGRP RELATED DISORDERS)
Eurasian Patent Organization	202092278	РИМЕГЕПАНТ ДЛЯ СВЯЗАННЫХ С CGRP РАССТРОЙСТВ
South Korea	101875353
Singapore	11202009199Y	RIMEGEPANT FOR CGRP RELATED DISORDERS
Croatia	P20191655

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	PA2022516	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	C202230042	Spain		PRODUCT NAME: RIMEGEPANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1645; DATE OF AUTHORISATION: 20220425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1645; DATE OF FIRST AUTHORISATION IN EEA: 20220425
2488512	CR 2022 00036	Denmark		PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426