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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,117,836 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

See all ubrogepant clinical trials

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

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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

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Glossary

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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	10,117,836	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,925,709	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	8,912,210	⤷ Subscribe	Y	Y		⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	8,754,096	⤷ Subscribe	Y	Y		⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,857,542	⤷ Subscribe				⤷ Subscribe
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,499,545	⤷ Subscribe	Y	Y		⤷ Subscribe
>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

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Country	Patent Number	Title	Estimated Expiration
Taiwan	201520213	Piperidinone carboxamide azaindane CGRP receptor antagonists	⤷ Subscribe
Chile	2013001289	Compuestos derivados de n-[2-oxo-5-fenil-piperidin-3-il]-[2’-oxo-espiro[ciclopenta[b]piridin-6,3’-pirrol[2,3-b]piridina] o 6’-oxo-espiro[ciclopenta[b]piridin-6,5’-pirrol[2,3-d]pirimidina]]-3-carboxamida, antagonistas de receptor del cgrp; composicion farmaceutica; y su uso para tratar la cefalea migrañosa.	⤷ Subscribe
South Korea	101537877		⤷ Subscribe
Australia	2023258317		⤷ Subscribe
Brazil	112016017999		⤷ Subscribe
Canada	3206184	TRAITEMENT DE LA MIGRAINE (TREATMENT OF MIGRAINE)	⤷ Subscribe
Australia	2021409718		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ubrogepant

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	C02638042/01	Switzerland	⤷ Subscribe	PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	34/2023	Austria	⤷ Subscribe	PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814
2638042	122023000058	Germany	⤷ Subscribe	PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	LUC00321	Luxembourg	⤷ Subscribe	PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	PA2023532	Lithuania	⤷ Subscribe	PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark	⤷ Subscribe	PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	301248	Netherlands	⤷ Subscribe	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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