Ubrogepant - Generic Drug Details
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What are the generic sources for ubrogepant and what is the scope of patent protection?
Ubrogepant
is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ubrogepant has one hundred and three patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for ubrogepant
International Patents: | 103 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 13 |
Patent Applications: | 121 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ubrogepant |
What excipients (inactive ingredients) are in ubrogepant? | ubrogepant excipients list |
DailyMed Link: | ubrogepant at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ubrogepant
Generic Entry Date for ubrogepant*:
Constraining patent/regulatory exclusivity:
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 ubrogepant
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 ubrogepant
Drug Class | Calcitonin Gene-related Peptide Receptor Antagonist |
Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ubrogepant
Paragraph IV (Patent) Challenges for UBROGEPANT
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 ubrogepant
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 | 211765-002 | Dec 23, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 | 211765-002 | 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 | ⤷ Sign Up | ||||
Abbvie | UBRELVY | ubrogepant | TABLET;ORAL | 211765-001 | Dec 23, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ubrogepant
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5642883 | ⤷ Sign Up | |
Canada | 2937942 | ⤷ Sign Up | |
Cyprus | 1118362 | ⤷ Sign Up | |
Norway | 2023040 | ⤷ Sign Up | |
China | 112022818 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ubrogepant
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 2023C/541 | Belgium | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814 |
2638042 | C02638042/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024 |
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 | LUC00321 | Luxembourg | ⤷ Sign Up | 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 |
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