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 three 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
Chicago Headache Center & Research Institute	Phase 4
AbbVie	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

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
European Patent Office	3102211
Cyprus	1115867
Taiwan	201520214	Piperidinone carboxamide azaindane CGRP receptor antagonists
European Patent Office	3102210
Mexico	383378	FORMULACIÓN DE TABLETA PARA COMPUESTOS ACTIVOS DE PÉPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)

Supplementary Protection Certificates for UBRELVY

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	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	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	C20230034	Finland

Market Dynamics and Financial Trajectory for Ubrelvy (ubrogepant)

Last updated: December 29, 2025

Executive Summary

Ubrelvy (ubrogepant) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) in October 2019 for the acute treatment of migraine with or without aura in adults. As a calcitonin gene-related peptide (CGRP) receptor antagonist, Ubrelvy represents a significant advancement in migraine therapy, directly competing with both triptans and other CGRP inhibitors.

This report offers a comprehensive analysis of Ubrelvy's market dynamics and financial trajectory, including current market position, growth drivers, competitive landscape, regulatory environment, and revenue forecasts. The goal is to provide business professionals and investors with in-depth insights for strategic decision-making within the evolving migraine therapeutics sector.

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Market Overview

Global Migraine Market Size and Trends

The global migraine drug market is projected to reach USD 8.34 billion by 2027, growing at a CAGR of 4.8% from 2020 to 2027 (Ref: Fortune Business Insights). This sustained growth is driven by increasing migraine prevalence, technological advancements, and the approval of innovative therapeutics like CGRP antagonists.

Prevalence and Impact of Migraine

• Approximate prevalence of migraine globally: 1 billion people (~14% global population) (WHO, 2019).
• Affects predominantly women (75%) and young adults.
• Significant socioeconomic burden, estimated at USD 78 billion annually in the U.S. alone in healthcare costs and productivity losses.

Key Drivers for Ubrelvy

Driver	Impact	Source/Notes
Rising migraine prevalence	Expands target population	WHO (2019)
Limitations of existing therapies	Creates unmet needs	EMA & FDA reviews
Growing acceptance of CGRP antagonists	Adoption increase	Market reports, FDA approvals
Greater healthcare access & insurance coverage	Facilitates prescriptions	CMS policies
Patient preference for rapid relief	Favorables Ubrelvy’s profile	Clinical studies

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Ubrelvy’s Product Profile and Positioning

Attribute	Details
Generic Name	Ubrogepant
Formulation	Oral tablets (50 mg, 100 mg)
Approval Date	October 2019 (FDA)
Indication	Acute treatment of migraine with or without aura
Mechanism of Action	CGRP receptor antagonist
Key Advantages	Rapid onset (within 30 minutes), minimal cardiovascular risk, good tolerability

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Market Penetration and Commercial Strategy

Initial Launch and Adoption

• Launched in the U.S. by AbbVie, a major player in headache therapeutics.
• Initial focus on neurologists and headache specialists.
• Early adoption was constrained by limited patient awareness, insurance hurdles, and competition with established drugs.

Market Penetration Metrics

Year	U.S. Prescriptions	Market Share (Estimated)	Notes
2019	~50,000	N/A (approval year)	Limited launch in late 2019
2020	~250,000	~2% of migraine drug prescriptions	Growing awareness
2021	~500,000	~4%	Expanded digital marketing and insurance coverage
2022	~1,200,000	~8%	Increased formulary listing

Data Sources: IQVIA, EvaluatePharma

Pricing Strategy

• Average Wholesale Price (AWP): USD 50–70 per tablet (varies by supplier/investor reports).
• Insurance reimbursements generally align, with copay cards and patient assistance programs increasing access.

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Competitive Landscape

Major Competitors

Company	Product	Type	Indication	Launch Year	Key Differentiator
Eli Lilly	Emgality (galcanezumab)	CGRP monoclonal antibody	Prevention	2018	Preventive therapy
Amgen & Novartis	Aimovig (erenumab)	CGRP monoclonal antibody	Prevention	2018	Once-monthly injections
Eli Lilly	Reyvow (lasmiditan)	Serotonin receptor agonist	Acute	2019	No vasoconstriction, suitable for cardiovascular patients
AbbVie	Ubrelvy (ubrogepant)	Oral CGRP receptor antagonist	Acute	2019	Rapid relief, oral

Note: The competitive dynamics are evolving with new entrants and expanding indications.

Market Share Distribution

Segment	Market Share (Estimate, 2022)	Notes
Triptans	~55%	Still dominant, especially for severe attacks
CGRP Monoclonal Antibodies	~25%	Primarily preventive
Ubrogepant & Other Oral Agents	~10%	Growing, especially in acute treatment
Lasmiditan & Others	~10%	Niche players for specific patient groups

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Regulatory and Reimbursement Environment

Regulatory Milestones

• FDA Approval: October 2019 for acute migraine.
• EMA & Other Regions: Pending or under review.
• Orphan designations and orphan-drug incentives are not applicable but fast-track status facilitated swift approval.

Reimbursement Policies

• Insurance Coverage: Widely covered in the U.S., with formulary inclusion improving.
• Cost-Effectiveness: Demonstrated via clinical trials, positioning Ubrelvy as a cost-effective alternative to triptans for suitable patients.

Barriers to Adoption

• High per-unit cost.
• Limited awareness among primary care physicians.
• Insurance formulary restrictions.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Data

Year	Revenue (USD million)	Notes
2019	~$50	Limited launch year
2020	~$150	Increased prescriptions, expanded access
2021	~$300	Market expansion, awareness campaigns
2022	~$550	Penetration into additional healthcare settings

Forecast Assumptions

Assumption	Details
CAGR	~40% for 2023–2027
Market Penetration	Increasing adoption with 15–20% market share among acute treatments
Pricing	Stable or slight increase aligned with inflation and demand
Competitors	Continued competition, potential new entrants

Projected Financials (2023–2027)

Year	Estimated Revenue (USD millions)	CAGR	Key Drivers
2023	~$770	40%	Expanded payer coverage, increased prescriptions
2024	~$1,075	40%	Further market adoption, new regions
2025	~$1,500	40%	Incorporation of additional formulations or indications
2026	~$2,100	40%	Potential line extensions, increased awareness
2027	~$2,940	40%	Maturity phase, steady growth

Note: These projections assume continued market expansion and no significant breakthroughs for competitors.

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Comparison with Market Benchmarks

Parameter	Ubrelvy	Triptans	CGRP Monoclonal Antibodies	Lasmiditan
Time to Onset	~30 minutes	30–60 minutes	N/A	2 hours
Administration	Oral	Oral	Injectable	Oral
Safety Profile	Favorable	Vasoconstriction risk	Long-term data	CNS side effects
Market Penetration	Growing	Dominant	Rapid growth	Niche
Pricing (per dose)	USD 50–70	USD 10–20	USD 700–1000	USD 70–100

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Key Market Trends and Future Outlook

1. Shift Toward Oral CGRP Antagonists: As efficacy and safety are proven, oral agents like Ubrelvy are increasingly preferred for rapid relief.
2. Expansion into Preventive Therapy: Trials for preventive use are underway, potentially broadening market scope.
3. Personalized Medicine: Patient stratification using genetics could optimize therapy choices, influencing revenue.
4. Digital and Remote Monitoring: Integration with telehealth may expand prescriptions.
5. Market Consolidation: Larger pharma entities may acquire or partner to strengthen portfolios.

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Deep Dive: Strategic Recommendations

• For Investors: Focus on companies expanding CGRP portfolio offerings, especially oral agents with rapid onset similar to Ubrelvy.
• For Manufacturers: Invest in education campaigns targeting primary care and incorporating patient feedback.
• For Payers: Adopt value-based reimbursement models linking prescription cost-effectiveness to outcomes.
• For Policymakers: Streamline approval pathways and support patient access programs.

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Conclusion

Ubrelvy is poised to capitalize on the growing demand for effective, rapid, oral migraine therapies. Its market trajectory is buoyed by the rising prevalence of migraine, enhanced patient preferences, and the expanding acceptance of CGRP receptor antagonists. While competition from monoclonal antibodies and other acute treatments remains intense, Ubrelvy’s unique positioning offers substantial revenue potential over the next five years, especially as awareness and access improve.

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Key Takeaways

• Market Growth: The migraine therapeutics market is projected to reach over USD 8 billion by 2027, with Ubrelvy contributing significantly.
• Revenue Outlook: Achievable CAGR of approximately 40%, with revenues potentially rising over USD 2.9 billion by 2027.
• Competitive Edge: Rapid onset, favorable safety profile, and oral administration position Ubrelvy favorably.
• Challenges: High pricing, insurance access, and competition necessitate strategic marketing and educational efforts.
• Opportunities: Expansion into preventive uses, combination therapies, and personalized treatment pathways.

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FAQs

1. What sets Ubrelvy apart from triptans?
   Ubrelvy offers rapid onset of relief with a lower cardiovascular risk profile, making it suitable for patients who cannot tolerate vasoconstrictive agents like triptans.

2. How does Ubrelvy compare to other CGRP antagonists?
   As an oral medication, Ubrelvy provides faster, non-injectable treatment options, whereas monoclonal antibodies are primarily preventive and administered less frequently.

3. Is Ubrelvy covered by most insurance plans?
   Coverage has improved since launch, with formulary inclusion in many plans, supported by its cost-effectiveness and clinical benefits.

4. Are there plans to expand Ubrelvy’s indications?
   Currently approved for acute migraine, clinical trials are exploring preventive use and other migraine subtypes.

5. What are the main barriers to Ubrelvy's market expansion?
   High cost, insurance restrictions, limited patient and physician awareness, and emerging competition pose significant challenges.

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References

[1] Fortune Business Insights, “Migraine Drugs Market Size, Share & Industry Analysis,” 2022.
[2] World Health Organization, “Migraine Fact Sheet,” 2019.
[3] IQVIA Data, “Pharmaceutical Market Analytics,” 2022.
[4] FDA Approval Announcement, “Ubrelvy (ubrogepant) for Acute Migraine,” October 2019.
[5] EvaluatePharma, “Migraine Treatment Market Forecasts,” 2022.