UBROGEPANT - Generic Drug Details

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What are the generic drug sources for ubrogepant and what is the scope of freedom to operate?

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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Chicago Headache Center & Research Institute	Phase 4
AbbVie	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	211765-002	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	Y	Y		⤷ Sign Up
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				⤷ 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
>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
Netherlands	301248		⤷ Sign Up
Taiwan	201520213	Piperidinone carboxamide azaindane CGRP receptor antagonists	⤷ Sign Up
Canada	3206184	TRAITEMENT DE LA MIGRAINE (TREATMENT OF MIGRAINE)	⤷ Sign Up
European Patent Office	3102210	COMPOSITION PHARMACEUTIQUE D'INHIBITEURS SÉLECTIFS DE LA NS3/4A DU HCV (PHARMACEUTICAL COMPOSITION OF SELECTIVE HCV NS3/4A INHIBITORS)	⤷ Sign Up
Brazil	112013011448	composto, composição farnmacêutica, e, uso do composto	⤷ Sign Up
Lithuania	2821407		⤷ Sign Up
>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	PA2023532	Lithuania	⤷ Sign Up	PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	122023000058	Germany	⤷ Sign Up	PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; 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	34/2023	Austria	⤷ Sign Up	PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 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	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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