UBRELVY Drug Patent Profile
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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 twelve patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and four 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
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Summary for UBRELVY
International Patents: | 104 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 7 |
Patent Applications: | 148 |
Drug Prices: | Drug price information for UBRELVY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for UBRELVY |
What excipients (inactive ingredients) are in UBRELVY? | UBRELVY excipients list |
DailyMed Link: | UBRELVY at DailyMed |


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
Sponsor | Phase |
---|---|
AbbVie | Phase 1 |
Chicago Headache Center & Research Institute | Phase 4 |
AbbVie | Phase 4 |
Pharmacology for UBRELVY
Drug Class | Calcitonin Gene-related Peptide Receptor Antagonist |
Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
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 thirteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of UBRELVY is ⤷ Try for Free.
This potential generic entry date is based on patent 10,117,836.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,754,096 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-002 | Dec 23, 2019 | RX | Yes | Yes | 12,168,004 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | 11,857,542 | ⤷ Try for Free | ⤷ Try for Free | ||||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | 11,717,515 | ⤷ Try for Free | ⤷ Try for Free | ||||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | 10,117,836 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-002 | Dec 23, 2019 | RX | Yes | Yes | 11,925,709 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Try for Free
Patent: 19226239
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Try for Free
Patent: 21245229
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Try for Free
Patent: 21409718
Patent: TREATMENT OF MIGRAINE
Estimated Expiration: ⤷ Try for Free
Patent: 23258317
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2016017999
Patent: COMPRIMIDO, E, FORMULAÇÃO ADEQUADA PARA PRENSAR EM UM COMPRIMIDO
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 37315
Patent: FORMULATION DE COMPRIME POUR COMPOSES ACTIFS VIS-A-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 37942
Patent: COMBINAISONS A DOSE FIXE DE COMPOSES ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 06184
Patent: TRAITEMENT DE LA MIGRAINE (TREATMENT OF MIGRAINE)
Estimated Expiration: ⤷ Try for Free
China
Patent: 5939715
Patent: 抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 5960397
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Try for Free
Patent: 2022818
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 02188
Patent: NOUVEAUX SYSTÈMES DE DÉSINTÉGRATION DE FORMES DOSIFIÉES PHARMACEUTIQUES (NOVEL DISINTEGRATION SYSTEMS FOR PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Try for Free
Patent: 02210
Patent: COMPOSITION PHARMACEUTIQUE D'INHIBITEURS SÉLECTIFS DE LA NS3/4A DU HCV (PHARMACEUTICAL COMPOSITION OF SELECTIVE HCV NS3/4A INHIBITORS)
Estimated Expiration: ⤷ Try for Free
Patent: 02211
Patent: COMBINAISONS À DOSE FIXE DE COMPOSÉS ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 02564
Patent: FORMULATION DE COMPRIMÉ POUR COMPOSÉS ACTIFS VIS-À-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 37412
Patent: FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 32218
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 6828
Patent: פורמולציית טבליה לחומרים הפועלים על cgrp (Tablet formulation for cgrp-active compounds)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 91669
Estimated Expiration: ⤷ Try for Free
Patent: 66490
Estimated Expiration: ⤷ Try for Free
Patent: 17505306
Patent: CGRP活性化合物の錠剤製剤
Estimated Expiration: ⤷ Try for Free
Patent: 19108366
Patent: CGRP活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 16010169
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷ Try for Free
Patent: 21006790
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷ Try for Free
Patent: 23007575
Patent: TRATAMIENTO DE LA MIGRAÑA. (TREATMENT OF MIGRAINE.)
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 96578
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 19123406
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Try for Free
Saudi Arabia
Patent: 6371613
Patent: CGRP صيغة قرص لمركبات نشطة تجاه (Tablet Formulation for CGRP-Active Compounds)
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2448369
Estimated Expiration: ⤷ Try for Free
Patent: 160113296
Patent: CGRP-활성 화합물에 대한 정제 제제 (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 220136460
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 230107902
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
China | 105939715 | 抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2015119919 | ⤷ Try for Free | |
Taiwan | I487706 | ⤷ Try for Free | |
Japan | 2019108366 | CGRP活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS) | ⤷ Try for Free |
European Patent Office | 3237412 | FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS) | ⤷ Try for Free |
Slovenia | 2638042 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for UBRELVY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2638042 | C02638042/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024 |
2638042 | 34/2023 | Austria | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814 |
2638042 | 301248 | Netherlands | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814 |
2638042 | CR 2023 00033 | Denmark | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814 |
2638042 | 122023000058 | Germany | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811 |
2638042 | LUC00321 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Ubrelvy
More… ↓