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QULIPTA Drug Patent Profile

Which patents cover Qulipta, and when can generic versions of Qulipta launch?

Qulipta is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and two patent family members in forty-five countries.

The generic ingredient in QULIPTA is atogepant. One supplier is listed for this compound. Additional details are available on the atogepant profile page.

DrugPatentWatch^® Generic Entry Outlook for Qulipta

Qulipta will be eligible for patent challenges on September 28, 2025. 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.

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

Summary for QULIPTA

International Patents:	102
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	7
Patent Applications:	25
Drug Prices:	Drug price information for QULIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QULIPTA
What excipients (inactive ingredients) are in QULIPTA?	QULIPTA excipients list
DailyMed Link:	QULIPTA at DailyMed

See drug prices for QULIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QULIPTA

NDA:

215206

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 QULIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AbbVie	Phase 1
AbbVie	Phase 3
Allergan	Phase 4

See all QULIPTA clinical trials

Pharmacology for QULIPTA

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for QULIPTA

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

US Patents and Regulatory Information for QULIPTA

QULIPTA is protected by four US patents and two FDA Regulatory Exclusivities.

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 QULIPTA

FDA Regulatory Exclusivity protecting QULIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No			Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for QULIPTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Aquipta	atogepant	EMEA/H/C/005871 Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month	Authorised	no	no	no	2023-08-11

International Patents for QULIPTA

When does loss-of-exclusivity occur for QULIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Saudi Arabia

South Korea

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 QULIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016105670
European Patent Office	3430906	FORMES CRISTALLINES D'ANTAGONISTES DES RÉCEPTEURS DE CGRP (CRYSTALLINE FORMS OF CGRP RECEPTOR ANTAGONISTS)
Morocco	34650	ANTAGONISTES DU RÉCEPTEUR CGRP DE PIPÉRIDINONE CARBOXAMIDE AZAINDANE
Singapore	190137	PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS
World Intellectual Property Organization (WIPO)	2012064910
Taiwan	201520214	Piperidinone carboxamide azaindane CGRP receptor antagonists
China	103328478	Piperidinone carboxamide azaindane cgrp receptor antagonists

Supplementary Protection Certificates for QULIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	PA2023532	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814