UBRELVY Drug Patent Profile

Which patents cover Ubrelvy, and when can generic versions of Ubrelvy launch?

Ubrelvy is a drug marketed by Allergan and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-eight patent family members in forty-one countries.

The generic ingredient in UBRELVY is ubrogepant. One supplier is listed for this compound. Additional details are available on the ubrogepant profile page.

DrugPatentWatch^® Generic Entry Outlook for Ubrelvy

Ubrelvy will be eligible for patent challenges on December 23, 2023. 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 January 30, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for UBRELVY

International Patents:	88
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	5
Patent Applications:	73
Drug Prices:	Drug price information for UBRELVY
What excipients (inactive ingredients) are in UBRELVY?	UBRELVY excipients list
DailyMed Link:	UBRELVY at DailyMed

See drug prices for UBRELVY

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for UBRELVY

NDA:

211765

Dosage:

TABLET;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 UBRELVY

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

Sponsor	Phase
Allergan	Phase 4
Messoud Ashina, MD	Phase 4
Allergan	Phase 3

See all UBRELVY clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for UBRELVY

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

US Patents and Regulatory Information for UBRELVY

UBRELVY is protected by five US patents and one FDA Regulatory Exclusivity.

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 UBRELVY

FDA Regulatory Exclusivity protecting UBRELVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No			Y	Y
Allergan	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes			Y	Y
Allergan	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No			Y
Allergan	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes

International Patents for UBRELVY

When does loss-of-exclusivity occur for UBRELVY?

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

Australia

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Saudi Arabia

South Korea

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 UBRELVY around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2937942	COMBINAISONS A DOSE FIXE DE COMPOSES ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Saudi Arabia	516371613	CGRP صيغة قرص لمركبات نشطة تجاه (Tablet Formulation for CGRP-Active Compounds)
World Intellectual Property Organization (WIPO)	2015119919
Poland	2821407