You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 24, 2024

~ Buy the UBRELVY (ubrogepant) Drug Profile, 2024 PDF Report in the Report Store ~

UBRELVY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Ubrelvy is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in forty-five 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 was eligible for patent challenges on December 23, 2023.

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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

Drug patent expirations by year for UBRELVY
Drug Prices for UBRELVY

See drug prices for UBRELVY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for UBRELVY
Generic Entry Date for UBRELVY*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
AbbViePhase 1
Chicago Headache Center & Research InstitutePhase 4
AbbViePhase 4

See all UBRELVY clinical trials

Paragraph IV (Patent) Challenges for UBRELVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UBRELVY Tablets ubrogepant 50 mg and 100 mg 211765 4 2023-12-26

US Patents and Regulatory Information for UBRELVY

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UBRELVY is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Tablet formulation for CGRP active compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE HEPATIC IMPAIRMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE RENAL IMPAIRMENT

Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS

Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS

Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS

FDA Regulatory Exclusivity protecting UBRELVY

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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

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

Patent: 15214502
Estimated Expiration: ⤷  Sign Up

Patent: 19226239
Estimated Expiration: ⤷  Sign Up

Patent: 21245229
Estimated Expiration: ⤷  Sign Up

Patent: 23258317
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2016017999
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 37315
Estimated Expiration: ⤷  Sign Up

Patent: 37942
Estimated Expiration: ⤷  Sign Up

China

Patent: 5939715
Estimated Expiration: ⤷  Sign Up

Patent: 5960397
Estimated Expiration: ⤷  Sign Up

Patent: 2022818
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 02188
Estimated Expiration: ⤷  Sign Up

Patent: 02210
Estimated Expiration: ⤷  Sign Up

Patent: 02211
Estimated Expiration: ⤷  Sign Up

Patent: 02564
Estimated Expiration: ⤷  Sign Up

Patent: 37412
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 32218
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6828
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 91669
Estimated Expiration: ⤷  Sign Up

Patent: 66490
Estimated Expiration: ⤷  Sign Up

Patent: 17505306
Estimated Expiration: ⤷  Sign Up

Patent: 19108366
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 16010169
Estimated Expiration: ⤷  Sign Up

Patent: 21006790
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 96578
Estimated Expiration: ⤷  Sign Up

Patent: 19123406
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 6371613
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2448369
Estimated Expiration: ⤷  Sign Up

Patent: 160113296
Estimated Expiration: ⤷  Sign Up

Patent: 220136460
Estimated Expiration: ⤷  Sign Up

Patent: 230107902
Estimated Expiration: ⤷  Sign Up

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
Australia 2021245229 Tablet formulation for CGRP-active compounds ⤷  Sign Up
Finland C20230034 ⤷  Sign Up
Japan 6491669 ⤷  Sign Up
Lithuania 2821407 ⤷  Sign Up
Russian Federation 2696578 ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS) ⤷  Sign Up
Denmark 2638042 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2015120014 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UBRELVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2638042 LUC00321 Luxembourg ⤷  Sign Up PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042 CR 2023 00033 Denmark ⤷  Sign Up PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042 301248 Netherlands ⤷  Sign Up PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042 2023C/541 Belgium ⤷  Sign Up PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042 122023000058 Germany ⤷  Sign Up PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042 34/2023 Austria ⤷  Sign Up PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814
2638042 PA2023532 Lithuania ⤷  Sign Up PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.