UBRELVY Drug Patent Profile

When do Ubrelvy patents expire, and what generic alternatives are available?

Ubrelvy is a drug marketed by Abbvie and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nine patent family members in forty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ubrelvy

Ubrelvy was eligible for patent challenges on December 23, 2023.

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.

There is one tentative approval for the generic drug (ubrogepant), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for UBRELVY

International Patents:	109
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for UBRELVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UBRELVY
What excipients (inactive ingredients) are in UBRELVY?	UBRELVY excipients list
DailyMed Link:	UBRELVY at DailyMed

See drug prices for UBRELVY

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

Constraining patent/regulatory exclusivity:

10,117,836

NDA:

211765

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 UBRELVY

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 UBRELVY clinical trials

Pharmacology for UBRELVY

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

Paragraph IV (Patent) Challenges for UBRELVY

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 UBRELVY

UBRELVY is protected by seventeen US patents.

This potential generic entry date is based on patent 10,117,836.

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	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	12,458,632		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	8,754,096		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	9,833,448
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	10,117,836		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,717,515
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,925,709		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	12,070,450

International Patents for UBRELVY

When does loss-of-exclusivity occur for UBRELVY?

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 UBRELVY around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	53610	ANTAGONISTI PIPERIDINON KARBOKSAMID AZAINDAN CGRP RECEPTORA (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS)
Morocco	34650	ANTAGONISTES DU RÉCEPTEUR CGRP DE PIPÉRIDINONE CARBOXAMIDE AZAINDANE
Poland	2821407
Taiwan	I487706
Mexico	2021006790	FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Canada	2937942
New Zealand	610468	Piperidinone carboxamide azaindane cgrp receptor antagonists

Supplementary Protection Certificates for UBRELVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	PA2023532,C2638042	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	C20230034	Finland
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	23C1039	France		PRODUCT NAME: ATOGEPANT DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814

Market Dynamics and Financial Trajectory for UBRELVY

Last updated: July 27, 2025

Introduction

UBRELVY (ubrogepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist developed and marketed by AbbVie for the acute treatment of migraine attacks in adults. Since its approval by the U.S. Food and Drug Administration (FDA) in October 2019, UBRELVY has positioned itself within a rapidly expanding neurology therapeutics market, driven by the rising prevalence of migraines globally. This analysis explores the market dynamics influencing UBRELVY’s trajectory and forecasts its financial potential within the evolving pharmaceutical landscape.

Market Overview

Migraine Market Size and Growth

Migraines affect approximately 15% of the global population, equating to over 1 billion individuals, with significant disability and economic burden. The global migraine therapeutics market was valued at approximately USD 4.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of about 8% through 2028 [1].

Factors propelling growth include increased awareness, rising prevalence, and a shift toward targeted therapies such as CGRP antagonists. The North American market remains dominant, owing to advanced healthcare infrastructure, higher diagnosis rates, and favorable reimbursement environments. Conversely, expanding markets in Asia-Pacific and Europe further augment growth potential.

Competitive Landscape

UBRELVY faces competition from both small-molecule triptans and newer CGRP-based therapies. Its primary competitors include:

• Erenumab (Aimovig) by Amgen and Novartis, a CGRP monoclonal antibody approved for migraine prophylaxis.
• Fremanezumab (Ajovy) and Galcanezumab (Emgality), other CGRP monoclonal antibodies.
• Nurtec ODT (rimegepant) by Biohaven, an orally administered CGRP antagonist approved for both acute and preventive migraine treatment.

The entry of these therapies intensified competition, but UBRELVY's oral administration, rapid onset, and distinct dosing profile confer differentiation advantages, especially for acute management.

Market Dynamics Affecting UBRELVY

Regulatory and Reimbursement Factors

Regulatory approvals across key markets enhance UBRELVY’s commercial prospects. The drug’s designation as a 'breakthrough therapy' in some territories expedites market access. Insurance coverage and favorable formulary positioning are vital; initial challenges relate to reimbursement costs and establishing cost-effectiveness compared to existing treatments.

Patient and Physician Acceptance

The therapy’s efficacy and tolerability profiles influence prescribing behaviors. UBRELVY’s status as an oral medication appeals to patients preferring non-injective options, supporting adoption. Education initiatives targeting healthcare providers about its benefits over traditional therapies influence market uptake.

Pricing Strategy and Market Penetration

Pricing remains a critical factor. UBRELVY’s cost must balance profitability and competitiveness against other CGRP antagonists and triptans. AbbVie’s established sales force, marketing capabilities, and patient assistance programs facilitate market penetration.

Healthcare Trends and Digital Medicine

The trend toward personalized medicine, coupled with digital health tools, influences treatment paradigms. UBRELVY’s real-world effectiveness data bolster its positioning as a first-line acute therapy, especially if integrated with digital migraine monitoring apps.

Financial Trajectory and Revenue Forecasts

Sales Performance Since Launch

Following its 2019 approval, UBRELVY has experienced steady sales growth. In 2021, U.S. net product sales were estimated at USD 240 million, driven by increased prescriptions as awareness and physician familiarity grew [2].

Revenue Drivers

• Market Penetration: Expanding beyond initial neurologist and headache specialist prescribers to primary care physicians.
• Global Expansion: Launches in Europe, Asia, and Latin America are anticipated, though timelines vary due to regulatory processes.
• Combination and Line Extension Opportunities: Potential future development of formulations combining UBRELVY with preventive agents or exploring its use in different migraine subtypes.

Growth Projections

Analysts project UBRELVY’s revenues could reach USD 600–800 million globally by 2027, contingent on competitive dynamics, market uptake, and approval of additional indications [3]. Growth is expected to be particularly robust in high-prevalence regions with emerging healthcare infrastructures.

Risks and Challenges

• Market Saturation: Increasing competition from other CGRP agents and generics.
• Pricing Pressures: Payers exert pressure on drug prices, affecting profitability.
• Regulatory and Legal Challenges: Patent expirations or legal disputes could impair revenue streams.
• Efficacy and Safety Profile: Long-term safety data are crucial for sustaining market confidence.

Strategic Opportunities to Enhance Financial Trajectory

• Diversification: Developing new formulations or combination therapies.
• Global Market Penetration: Early entry into underpenetrated regions.
• Digital Health Integration: Leveraging digital tools to enhance adherence and real-world evidence collection.
• Partnerships: Strategic alliances for broader distribution or co-marketing efforts.

Conclusion

UBRELVY’s emergence as an effective oral acute migraine treatment positions it favorably within a lucrative and expanding market. Its success hinges on strategic regulatory, commercial, and clinical maneuvers amidst intensifying competition. While near-term sales growth remains promising, sustained long-term profitability will depend on market acceptance, pricing strategies, regulatory landscape, and follow-on innovation.

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Key Takeaways

• UBRELVY is positioned within a rapidly growing migraine therapeutics market, with strong potential for global expansion.
• Competitive differentiation through oral administration and rapid onset supports UBRELVY’s adoption.
• Revenue projections indicate a trajectory toward USD 600–800 million globally by 2027, with growth driven by expanding indications and markets.
• Challenges include intense competition, pricing pressures, and regulatory risks, necessitating strategic agility.
• Embracing digital health initiatives and diversification can optimize UBRELVY’s financial trajectory.

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FAQs

1. What distinguishes UBRELVY from other migraine therapies?
UBRELVY is an oral CGRP receptor antagonist offering rapid relief for acute migraine attacks, providing an alternative to injectable monoclonal antibodies and traditional triptans.

2. How does UBRELVY’s market share compare to its competitors?
While still gaining market share, UBRELVY leverages its oral route and efficacy profile to capture a growing segment, though competitors like Aimovig and Nurtec are also expanding their presence.

3. What are the primary barriers to UBRELVY’s market growth?
Key barriers include reimbursement hurdles, competition from established and emerging therapies, and regulatory delays in new markets.

4. Are there planned expansions or indications for UBRELVY?
Future avenues include exploring preventive indications or combination formulations, though current focus remains on acute treatment.

5. How might healthcare trends influence UBRELVY’s future sales?
Digital health initiatives and personalized care approaches could enhance treatment adherence and data collection, positively impacting sales.

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References

[1] GlobalData, "Migraine Therapeutics Market Size & Trends," 2022.
[2] AbbVie Annual Report 2021.
[3] EvaluatePharma, "Pharma Revenue Forecasts," 2022.