Ubrogepant - Generic Drug Details

What are the generic 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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ubrogepant

International Patents:	109
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	15
Patent Applications:	374
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

Constraining patent/regulatory exclusivity:

10,117,836

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
H. Lundbeck A/S	PHASE1
AbbVie	PHASE3
AbbVie	Phase 1

See all ubrogepant clinical trials

Generic filers with tentative approvals for UBROGEPANT

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET
		100MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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	211765-001	Dec 23, 2019		RX	Yes	No	11,925,709		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	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	211765-001	Dec 23, 2019		RX	Yes	No	12,168,004		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	12,070,450
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,833,448

International Patents for ubrogepant

Country	Patent Number	Title	Estimated Expiration
Spain	2604827
Canada	2937315
Taiwan	I487706
Spain	2604827
South Korea	102448369
Spain	2525021

Supplementary Protection Certificates for ubrogepant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	2390026-9	Sweden		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	PA2023532,C2638042	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	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814

Market Dynamics and Financial Trajectory for Ubrogepant

Last updated: July 27, 2025

Introduction

Ubrogepant, marketed under the brand name Bemvexo (or Ubrelvy in some regions), is a groundbreaking oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by the FDA in 2019 for the acute treatment of migraines in adults. As one of the most recent entrants in the migraine therapeutics sector, ubrogepant's market dynamics and financial prospects are intricately linked to evolving healthcare trends, competitive landscape, and regulatory developments. This analysis comprehensively examines the factors shaping ubrogepant's market trajectory, discerning opportunities and challenges for stakeholders.

---

Market Overview and Growth Drivers

1. Rising Prevalence of Migraine

Migraine affects approximately 15% of the global population, translating into over 1 billion individuals worldwide [1]. In the U.S. alone, an estimated 39 million people experience migraines annually, with a substantial portion seeking effective acute treatments. Factors like increased awareness, better diagnostic practices, and lifestyle changes have contributed to a rising diagnosis rate, fueling demand for targeted therapies like ubrogepant.

2. Limitations of Traditional Migraine Therapies

Historically, triptans dominated migraine management but carry contraindications for patients with cardiovascular disease due to vasoconstrictive effects. This unmet need spurred the development of newer agents such as CGRP antagonists, including ubrogepant. Their favorable safety profile, especially in cardiovascular comorbidities, positions ubrogepant as a preferred option for diverse patient populations.

3. Innovation and Efficacy Profile

Ubrogepant offers rapid onset of relief, minimal systemic vasoconstriction, and low adverse effects, which are significant advantages over some existing therapies. Its oral formulation ensures convenience, boosting patient adherence. As a novel acute treatment, it fills a critical therapeutic gap, propelling initial and sustained demand.

---

Competitive Landscape

1. Patent and Market Exclusivity

Ubrogepant's initial approval in 2019 granted exclusivity until approximately 2039, providing a substantial window for market capture. However, the presence of rival CGRP antagonists, both oral and injectable, influences the competitive environment.

2. Key Competitors

• Erenumab (Aimovig): A monoclonal antibody targeting CGRP receptors, approved in 2018, primarily for preventive treatment [2].

• Fremanezumab (Ajovy): Injectable monoclonal antibody for prevention.

• Nurtec ODT (rimegepant): An oral CGRP antagonist approved in 2020 for both acute and preventive treatment.

• Zavegepant: An intranasal variant under investigation, expanding delivery options.

While erenumab and fremanezumab target prevention, ubrogepant’s role is strictly acute, positioning it uniquely within the treatment paradigm.

3. Market Share Dynamics

Initial adoption favored ubrogepant due to its safety profile and oral route. However, as the market matures, sustained growth hinges on clinician acceptance, insurance coverage, and novel formulations.

---

Regulatory and Reimbursement Landscape

1. Regulatory Approvals

Following FDA approval, other jurisdictions such as the European Medicines Agency (EMA) are evaluating ubrogepant, potentially expanding access. Regulatory pathways influence commercialization timelines and market penetration.

2. Insurance Coverage

Reimbursement policies significantly affect sales. Ubrogepant’s positioning—often prescribed after triptan failure—may lead to insurance formulary restrictions. Price negotiations and tier formulary placements impact prescription volume.

---

Market Penetration and Financial Projection Dynamics

1. Initial Adoption Trends

Pharmacovigilance and clinician familiarity shape early sales. During 2020–2022, sales experienced rapid growth with the initial number of prescriptions doubling annually, driven by increasing migraine prevalence and unmet needs.

2. Sales Forecasts

Projections estimate the global market for CGRP antagonists (both preventive and acute) will reach $8–10 billion by 2027, with ubrogepant potentially capturing 15–20% of the acute segment [3]. This equates to sales in the range of $500 million to $2 billion over the next five years, contingent on competitive pressures and formulary positioning.

3. Key Growth Factors

• Expanding Indications: Recent studies suggest potential for prevention indications with ubrogepant, which could diversify revenue streams.

• Patient Preference: Oral formulations favor patient adherence, fostering physician prescribing patterns conducive to sales growth.

• Digital and Telehealth Influence: Increasing telehealth consultations facilitate migraine diagnosis and prescription, especially post-pandemic.

4. Market Challenges

• Pricing Pressures: Payers demand competitive pricing; high drug costs may inhibit broad adoption.

• Generics and Biosimilars: While not yet in this space, eventual biosimilar entry to rivals could challenge market share.

• Physician and Patient Awareness: Continual education campaigns are necessary to maximize market penetration.

---

Emerging Trends and Future Outlook

1. Technological Advances

Development of combination therapies and novel delivery systems (e.g., nasal sprays, patches) could enhance convenience and adherence, expanding market share.

2. Expanding Patient Demographics

Research suggests potential for use in pediatric populations or specific subgroups with unique migraine profiles, opening new markets.

3. Geographic Expansion

Entry into emerging markets, such as China and Latin America, offers significant long-term revenue opportunities, provided regulatory and pricing hurdles are addressed.

---

Risks and Barriers

• Pipeline Competition: Larger pharmaceutical companies intensify CGRP antagonist pipelines, threatening market share.

• Regulatory Uncertainties: Approval delays in new indications or markets could restrain growth.

• Market Saturation: As more assets enter the space, price competition may diminish profit margins.

---

Key Takeaways

• Ubrogepant occupies a growing niche in acute migraine treatment, driven by its safety, efficacy, and oral administration.
• The global migraine market is expanding, with forecasts indicating significant revenue potential for ubrogepant within five years.
• Competition from preventive CGRP monoclonal antibodies and emerging treatments necessitates strategic positioning and continued innovation.
• Reimbursement pathways and clinician education are crucial for sustained growth.
• Future expansion into preventive indications and emerging markets could create new revenue streams, but regulatory and competitive challenges remain.

---

FAQs

1. What differentiates ubrogepant from other migraine therapies?
Ubrogepant is an oral CGRP receptor antagonist that effectively treats migraines without vasoconstrictive effects, making it safer for patients with cardiovascular risk factors compared to triptans.

2. How does patent exclusivity impact ubrogepant's market potential?
Patent protection until approximately 2039 grants exclusivity, allowing the manufacturer to capitalize on market penetration without generic competition initially. However, biosimilar or alternative therapies could challenge its market share later.

3. What are the main barriers to wider adoption of ubrogepant?
Insurance reimbursement limitations, high treatment costs, physician familiarity, and competition from other CGRP agents limit broader adoption.

4. What future indications could expand ubrogepant’s market?
Potential expansion includes preventive use, pending supportive clinical trials, and pediatric applications, which could significantly increase the patient population.

5. How does the global regulatory environment influence ubrogepant’s market trajectory?
Regulatory approvals in key markets like Europe and Asia will determine geographic expansion. Harmonization of approval processes could accelerate access and sales growth.

---

References

[1] Global Burden of Disease Study, 2019. Institute for Health Metrics and Evaluation.
[2] FDA Press Release, 2018. Erenumab approval.
[3] Market Research Future, 2022. CGRP antagonists global market outlook.