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 Allergan and is included in one NDA. There are five patents protecting this drug.
This drug has ninety-two 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: | 92 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| Clinical Trials: | 6 |
| Patent Applications: | 95 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Chicago Headache Center & Research Institute | Phase 4 |
| AbbVie | Phase 4 |
| Allergan | Phase 4 |
Pharmacology for UBRELVY
| Drug Class | Calcitonin Gene-related Peptide Receptor Antagonist |
| Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for UBRELVY
US Patents and Regulatory Information for UBRELVY
UBRELVY is protected by five US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of UBRELVY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
FDA Regulatory Exclusivity protecting UBRELVY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Allergan | UBRELVY | ubrogepant | TABLET;ORAL | 211765-002 | Dec 23, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Allergan | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Allergan | UBRELVY | ubrogepant | TABLET;ORAL | 211765-002 | Dec 23, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Patent: 19226239
Estimated Expiration: ⤷ Try a Trial
Patent: 21245229
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2016017999
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 37315
Estimated Expiration: ⤷ Try a Trial
Patent: 37942
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5939715
Estimated Expiration: ⤷ Try a Trial
Patent: 5960397
Estimated Expiration: ⤷ Try a Trial
Patent: 2022818
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 02188
Estimated Expiration: ⤷ Try a Trial
Patent: 02210
Estimated Expiration: ⤷ Try a Trial
Patent: 02211
Estimated Expiration: ⤷ Try a Trial
Patent: 02564
Estimated Expiration: ⤷ Try a Trial
Patent: 37412
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 32218
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6828
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 91669
Estimated Expiration: ⤷ Try a Trial
Patent: 66490
Estimated Expiration: ⤷ Try a Trial
Patent: 17505306
Estimated Expiration: ⤷ Try a Trial
Patent: 19108366
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 16010169
Estimated Expiration: ⤷ Try a Trial
Patent: 21006790
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 96578
Estimated Expiration: ⤷ Try a Trial
Patent: 19123406
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 6371613
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2448369
Estimated Expiration: ⤷ Try a Trial
Patent: 160113296
Estimated Expiration: ⤷ Try a Trial
Patent: 220136460
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015119848 | ⤷ Try a Trial | |
| Denmark | 2821407 | ⤷ Try a Trial | |
| Serbia | 53610 | ANTAGONISTI PIPERIDINON KARBOKSAMID AZAINDAN CGRP RECEPTORA (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS) | ⤷ Try a Trial |
| Dominican Republic | P2013000103 | ANTAGONISTAS DEL RECEPTOR DEL CGRP DE PIPERIDINONA CARBOXAMIDA AZAINDANO | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Serving leading biopharmaceutical companies globally:
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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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