QULIPTA Drug Patent Profile

Which patents cover Qulipta, and what generic alternatives are available?

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

This drug has one hundred and thirty-nine patent family members in forty-six 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 was eligible for patent challenges on September 28, 2025.

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:	139
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	7
Patent Applications:	2,211
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

US Patents and Regulatory Information for QULIPTA

QULIPTA is protected by seven 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.

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
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No			Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No			Y	Y
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	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/005871Aquipta 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
Singapore	190137	PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS
World Intellectual Property Organization (WIPO)	2016105670
Australia	2025202139
China	112638384
Norway	2023040
Mexico	2024015576
World Intellectual Property Organization (WIPO)	2015119924

Supplementary Protection Certificates for QULIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	C202330039	Spain		PRODUCT NAME: ATOGEPANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1750; DATE OF AUTHORISATION: 20230811; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1750; DATE OF FIRST AUTHORISATION IN EEA: 20230811
2638042	C20230034	Finland
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814

Market Dynamics and Financial Trajectory for QULIPTA

Last updated: July 27, 2025

Introduction

QULIPTA (atogepant) has rapidly emerged as a targeted therapeutic in the migraine prophylaxis landscape. Approved by the U.S. Food and Drug Administration (FDA) in September 2021, QULIPTA offers an oral, calcitonin gene-related peptide (CGRP) receptor antagonist tailored for episodic migraine prevention. This article analyzes the evolving market dynamics and forecasts the financial trajectory of QULIPTA, emphasizing competitive positioning, market potential, regulatory influences, and key drivers shaping its commercial success.

Market Landscape for Migraine Therapeutics

Migraine affects over 1 billion individuals globally, with a substantial impact on quality of life and economic productivity. The migraine market segments include acute treatments, such as triptans, and preventive therapies. The latter, historically reliant on off-label use and limited options, has experienced transformative change with the advent of CGRP-targeted therapies.

QULIPTA belongs to a new class of oral CGRP receptor antagonists, including Eli Lilly's Emgality (galcanezumab) and Amgen's Aimovig (erenumab). While injectable formulations dominate existing CGRP therapies, the oral route offers significant advantages in patient adherence and convenience, augmenting its potential for rapid adoption [1].

Market Dynamics Influencing QULIPTA’s Trajectory

1. Growing Preferential Demands for Oral Preventive Therapies

The preference shift toward oral medications significantly influences QULIPTA’s market penetration. Patients favor oral over injectable options due to ease of administration, reduced needle anxiety, and improved dosing flexibility. As healthcare providers recognize these preferences, oral CGRP antagonists like QULIPTA are likely to see increased adoption, particularly in patients intolerant to injections or with adherence challenges.

2. Competitive Landscape and Differentiation

QULIPTA faces competition from multiple entrants:

• Erenumab (Aimovig): The first CGRP monoclonal antibody approved for preventive migraine therapy.
• Galcanezumab (Emgality): Approved for episodic and chronic migraine prophylaxis.
• Eptinezumab (Vyepti): An IV formulation with a distinct administration schedule.
• Rimegepant (Nurtec ODT): Primarily an acute therapy with preventive potential.
• Ubrogepant (Ubrelvy): Focused on acute treatment; future prospects for prevention are evolving.

QULIPTA’s key differentiation is its oral format coupled with flexible dosing options (daily or as needed), potentially capturing a niche between monoclonal antibodies and existing oral options. Moreover, its relatively favorable side effect profile enhances competitive positioning [2].

3. Regulatory and Reimbursement Factors

Early favorable regulatory reviews, including potential expedited pathways, stimulate market confidence and accelerate adoption. Health insurers’ reimbursement policies critically influence access; positive formulary placements can rapidly drive uptake. The absence of high maintenance costs typical of biologics gives QULIPTA an advantage in outpatient and primary care settings.

4. Patient Population and Market Penetration

In the United States, approximately 39 million individuals suffer from episodic migraine, with about 15 million qualifying for preventive therapy [3]. Market penetration depends on physicians’ awareness, patient acceptance, and effective marketing. Early post-launch data indicate promising prescriber uptake, especially among patients with contraindications to monoclonal antibodies or those seeking oral options.

5. Pipeline and Future Indications

While initially approved for episodic migraine prevention, ongoing trials are exploring QULIPTA’s utility in chronic migraine and other off-label indications such as tension-type headaches. Expansion into broader migraine-related disorders could significantly augment its revenue streams.

Financial Trajectory of QULIPTA

1. Revenue Projections and Market Potential

Forecasting QULIPTA’s revenue involves conservative estimates of market share, pricing strategies, and utilization rates. Industry analysts project that by 2025, the global migraine prophylactic market could reach $4–6 billion, with oral CGRP antagonists garnering a growing segment.

A plausible scenario suggests that QULIPTA could capture 10–20% of this segment within five years, translating to revenues between $300 million to $1 billion worldwide. The U.S. remains the primary revenue driver due to its extensive healthcare infrastructure, with expanding markets in Europe and Asia presenting additional upside.

2. Pricing Strategy and Reimbursement Frameworks

QULIPTA's pricing is anticipated to align with other CGRP antagonists, likely in the range of $7,000–$10,000 annually per patient. Payer negotiations, biosimilar entries (once applicable), and managed care strategies will influence actual reimbursement levels and net revenues.

3. Market Share Dynamics

Initial adoption rates hinge on physician education, patient satisfaction, and real-world effectiveness data. Early market analyses indicate a gradual but steady increase in prescriptions, with a projected compounded annual growth rate (CAGR) of 15–20% for the next five years, assuming favorable regulatory developments and expanding indications.

4. Cost Considerations and Profitability

Margins are affected by research and development costs, manufacturing expenses, and marketing investments. Despite high initial R&D outlays, the scalable nature of oral small molecules supports high gross margins. As production efficiency improves and competition intensifies, price reductions could impact profitability, demanding strategic cost management.

5. Intellectual Property and Patent Lifespan

Patent protection extends QULIPTA’s exclusivity, with primary patents lasting until at least 2030. Patent challenges or new formulations may influence the longer-term market exclusivity, requiring continuous innovation and pipeline development to sustain revenue streams.

Regulatory and Market Risks

Regulatory delays or unfavorable decisions could hinder market launch and expansion. Additionally, competition from emerging oral CGRP antagonists, gepants, or novel mechanisms may dilute QULIPTA’s market share. The potential for off-label or combination therapy use further complicates the landscape, necessitating robust post-market surveillance.

Conclusion

QULIPTA is positioned to capitalize on the expanding migraine preventive market, driven by patient preferences for oral therapies and the clinical advantages of CGRP receptor antagonists. Its financial trajectory is optimistic, contingent upon effective commercialization, favorable reimbursement policies, and sustained innovation. While competitive pressures persist, QULIPTA’s unique attributes and expanding indications support its potential as a significant revenue contributor within neurological therapeutics.

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Key Takeaways

• The global migraine prophylactic market offers substantial growth opportunities, with oral CGRP antagonists like QULIPTA leading technological innovation.
• Patient preferences for oral, non-invasive therapies favor QULIPTA’s adoption, especially as healthcare systems emphasize outpatient and primary care management.
• Competitive differentiation, regulatory support, and reimbursement policies are pivotal in shaping its market penetration and revenue streams.
• Estimated market revenues for QULIPTA could reach $300 million to $1 billion within five years, dependent on uptake and market expansion.
• Sustained R&D, patent protection, and pipeline development are essential to maintaining competitive advantage and long-term financial success.

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FAQs

1. What distinguishes QULIPTA from other migraine preventive therapies?
QULIPTA’s oral administration route provides a significant convenience advantage over injectable biologics. Its selective CGRP receptor antagonism offers a favorable safety profile and targeted efficacy.

2. How does QULIPTA’s market potential compare to injectable CGRP therapies?
While biologics currently dominate the market, patient preference for oral options favors QULIPTA’s growth trajectory. Its ability to expand the preventative migraine market by attracting phobic or non-adherent patients boosts its potential.

3. What regulatory considerations could impact QULIPTA’s commercial success?
Positive initial regulatory decisions, potential for expedited pathways, and clear labeling support rapid market entry. Conversely, delays or safety concerns could slow adoption.

4. How might reimbursement policies influence QULIPTA’s sales?
Insurance coverage and formulary placement are critical. Favorable reimbursement reduces out-of-pocket costs, encouraging physicians and patients to opt for QULIPTA.

5. What is the outlook for the long-term profitability of QULIPTA?
With sustained demand, patent protection, and pipeline expansion, QULIPTA is poised to become a profitable product line. Market competition and pricing strategies will be key factors affecting its long-term financial outlook.

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References

[1] Bloomberg Intelligence. "Migraine Therapeutics Market Overview." 2022.
[2] U.S. FDA. "QULIPTA (Atogepant) Prescribing Information," 2021.
[3] American Migraine Foundation. "Migraine Prevalence and Impact," 2022.