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 nine patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and three 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: | 103 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 7 |
| Patent Applications: | 53 |
| 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
*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 |
| AbbVie | Phase 4 |
| Chicago Headache Center & Research Institute | 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 nine 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
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 UNDERGOING TREATMENT WITH A WEAK OR MODERATE CYP3A4 INDUCER
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 | Y | ⤷ Sign Up | ||
| Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 19226239
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 21245229
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 23258317
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016017999
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 37315
Patent: FORMULATION DE COMPRIME POUR COMPOSES ACTIFS VIS-A-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 37942
Patent: COMBINAISONS A DOSE FIXE DE COMPOSES ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 5960397
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Sign Up
Patent: 2022818
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 02188
Patent: NOUVEAUX SYSTÈMES DE DÉSINTÉGRATION DE FORMES DOSIFIÉES PHARMACEUTIQUES (NOVEL DISINTEGRATION SYSTEMS FOR PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 02210
Patent: COMPOSITION PHARMACEUTIQUE D'INHIBITEURS SÉLECTIFS DE LA NS3/4A DU HCV (PHARMACEUTICAL COMPOSITION OF SELECTIVE HCV NS3/4A INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 02211
Patent: COMBINAISONS À DOSE FIXE DE COMPOSÉS ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 02564
Patent: FORMULATION DE COMPRIMÉ POUR COMPOSÉS ACTIFS VIS-À-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 37412
Patent: FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 32218
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6828
Patent: פורמולציית טבליה לחומרים הפועלים על cgrp (Tablet formulation for cgrp-active compounds)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 91669
Estimated Expiration: ⤷ Sign Up
Patent: 66490
Estimated Expiration: ⤷ Sign Up
Patent: 17505306
Patent: ＣＧＲＰ活性化合物の錠剤製剤
Estimated Expiration: ⤷ Sign Up
Patent: 19108366
Patent: ＣＧＲＰ活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Russian Federation
Patent: 96578
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 19123406
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 6371613
Patent: CGRP صيغة قرص لمركبات نشطة تجاه (Tablet Formulation for CGRP-Active Compounds)
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2448369
Estimated Expiration: ⤷ Sign Up
Patent: 160113296
Patent: CGRP-활성 화합물에 대한 정제 제제 (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 220136460
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 230107902
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
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 |
|---|---|---|---|
| Portugal | 2821407 | ⤷ Sign Up | |
| China | 105939715 | 抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS) | ⤷ Sign Up |
| Ecuador | SP13012676 | ANTAGONISTAS DEL RECEPTOR DEL CGRP DE PIPERIDINONA CARBOXAMIDA AZAINDANO | ⤷ Sign Up |
| Australia | 2021409718 | TREATMENT OF MIGRAINE | ⤷ Sign Up |
| Ukraine | 109463 | ПІПЕРИДИНОНКАРБОКСАМІДАЗАІНДАНИ - АНТАГОНІСТИ РЕЦЕПТОРА CGRP | ⤷ 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 | 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 | PA2023532 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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