NURTEC ODT Drug Patent Profile

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

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

This drug has one hundred and three patent family members in thirty-five 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 will be eligible for patent challenges on February 27, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	103
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	1
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
Biohaven Ireland	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y
Biohaven Ireland	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Biohaven Ireland	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y
Biohaven Ireland	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Biohaven Ireland	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
Hungary	S2200033
Serbia	53149	ANTAGONISTI RECEPTORA ZA CGRP (CGRP RECEPTOR ANTAGONISTS)
Japan	6208154
Slovenia	2488512
South Korea	20120087940	CGRP RECEPTOR ANTAGONISTS

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	PA2022516	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	301187	Netherlands		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	33/2022	Austria		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 (MITTEILUNG) 20220426