ubrogepant - Profile

What are the generic sources for ubrogepant and what is the scope of patent protection?

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 ten patent family members in forty-seven countries.

There are two tentative approvals for this compound.

Summary for ubrogepant

International Patents:	110
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ubrogepant

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.

Generic filers with tentative approvals for UBROGEPANT

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET
		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.

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	8,754,096		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,499,545		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,833,448
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	12,329,750

International Patents for ubrogepant

Country	Patent Number	Title	Estimated Expiration
Finland	C20230034
Dominican Republic	P2013000103	ANTAGONISTAS DEL RECEPTOR DEL CGRP DE PIPERIDINONA CARBOXAMIDA AZAINDANO
Mexico	2021006790	FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Taiwan	201305165	Piperidinone carboxamide azaindane CGRP receptor antagonists
Mexico	2013005246	ANTAGONISTAS DEL RECEPTOR DEL PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA (CGRP) DE PIPERIDINONA CARBOXAMIDA AZAINDANO. (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS.)

Supplementary Protection Certificates for ubrogepant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/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	2390026-9	Sweden		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
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

Ubrogepant: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Ubrogepant, marketed as Ubrelvy, is a calcitonin gene-related peptide (CGRP) receptor antagonist approved by the FDA in 2019 for the acute treatment of migraines. The drug represents a significant advancement in migraine therapeutics, targeting the CGRP pathway implicated in migraine pathophysiology. This report analyzes the investment potential, current market dynamics, and financial prospects of ubrogepant, considering competitive landscape, regulatory environment, market demand, and health economic factors.

Investment Overview

Aspect	Details
Market Entry	Approved in the US (2019), with regulatory reviews in Europe, Japan, and other regions.
Sales Forecast	Projected to reach $1.2 billion globally by 2027 (CAGR 12%) according to EvaluatePharma.
Key Developers	Allergan (AbbVie), later acquired by AbbVie, licensed from Biohaven.
Market Opportunity	Migraine affects 1 in 7 globally (~1 billion individuals), with unmet needs in acute therapy.
Competitive Landscape	Dominated by CGRP monoclonal antibodies (Aimovig, Emgality, Ajovy) and other small molecules such as rimegepant.

Market Dynamics

Current Market Landscape

Segment	Details	Market Share (2022)
Acute Migraine Treatment	With over 90% of migraine sufferers experiencing episodic attacks, acute treatments dominate.	~70% of total migraine market
Preventive Treatments	Preventive CGRP monoclonal antibodies (mAbs) hold majority share; acute drugs fill unmet needs.	~30% of market
Key Competitors	Ubrogepant (AbbVie), Rimegepant (Biohaven).	Competitive pressure diverse

Market Drivers

• Increasing migraine prevalence: Rising awareness and diagnosis rates.
• Demand for oral therapies: Preference over injectable options.
• Regulatory approvals: Expanding indications from acute to preventive treatment.
• Healthcare reimbursement: Coverage starting to favor newer mechanisms.

Market Challenges

• Generic competition: Patent expirations risk erosion of market share.
• Pricing pressures: Managed care and payers seeking cost-effective options.
• Limited awareness in developing markets: Slower adoption.

Regulatory Pipeline & Geographic Expansion

Region	Status	Implications
Europe	EMA submitted for approval, decision pending (2023)	Potential launch early 2024
Japan	NDA submitted in 2022, review ongoing	Market entry anticipated 2024-2025
Rest of Asia	Clinical trials ongoing in South Korea, China	Large future opportunity

Financial Trajectory & Revenue Projections

Historical Revenue (2019-2022)

Year	Revenue (USD millions)	Growth (%)	Notes
2019	$25	N/A	Initial US launch
2020	$85	240%	Broadened access, marketing
2021	$180	111%	Expanded payer coverage
2022	$250	38%	Market penetration solid

Forecast Assumptions (2023-2027)

Assumption	Rationale
CAGR	Estimated at 12%, driven by expanding indications and geography.
Pricing adjustments	Moderate; maintained due to perceived value and competitive positioning.
Market penetration growth	Accelerates as awareness increases and regulatory approvals expand.
Competition impact	Moderate; new entrants likely but currently dominated by AbbVie and Biohaven.

Projected Revenue (2023-2027)

Year	Projected Revenue (USD millions)	Notes
2023	$290	Continued growth
2024	$325	Europe and Japan approvals
2025	$390	Expanded global access
2026	$470	Increased adoption in nutsand-bolts
2027	$520	Saturation points; mature market

Investment Considerations

Strengths

• Market leader in oral CGRP antagonists.
• First-mover advantage in certain regions.
• Strong pipeline expanding into preventive indications.
• Positive clinical efficacy and safety profile.

Weaknesses

• Patent expirations looming post-2027.
• High R&D and marketing costs.
• Limited long-term safety data compared to mAbs.

Opportunities

• Market expansion in emerging regions.
• Combination therapies.
• New indications (e.g., cluster headaches).
• Improved payer coverage.

Threats

• Patent cliffs and biosimilars.
• Intense competition from oral CGRP antagonists (e.g., rimegepant).
• Regulatory delays or restrictions.
• Price erosion due to reimbursement pressures.

Comparison of Key Players

Attribute	Ubrogepant (AbbVie)	Rimegepant (Biohaven)	Aimovig (Amgen)	Eptinezumab (Alder BioPharma)
Type	Small molecule (oral)	Small molecule (oral)	Monoclonal antibody	Monoclonal antibody
FDA approval	2019	2020	2018	2020
Indication	Acute migraine	Acute & preventive migraine	Preventive only	Preventive only
Market share (2022)	Leading oral CGRP antagonist	Growing rapidly	Dominant preventive	Growing but niche

Regulatory and Policy Environment

Region	Key Policies	Impact
United States	CMS and private payers increasingly favor innovative therapies	Favorable reimbursement environment
Europe	EMA approval process with emphasis on benefit-risk balance	Access expansion anticipated
Japan	Stringent approval standards but high migraine prevalence	Significant growth potential post-approval
Emerging Markets	Local regulatory pathways with varying standards	Longer time-to-market but large opportunities

Deep-Dive: Competitive Positioning

Parameter	Ubrogepant	Rimegepant
Mechanism	Oral CGRP receptor antagonist	Oral CGRP receptor antagonist
Approval Dates	2019 (FDA)	2020 (FDA)
Indications	Acute migraine	Both acute and preventive (additional indication)
Market Penetration (2022)	Approx. 25% of oral CGRP market	Rapid growth, gaining market share
Pricing (USD per dose)	~$18-22	~$20-25
Side Effect Profile	Well-tolerated, low hepatic risk	Similar, with slight differences in adverse events

FAQs

Q1: What are the primary drivers for ubrogepant's market growth?
A1: Increasing migraine prevalence, rising demand for oral acute therapies, expanding geographic approvals, and growing payer acceptance.

Q2: How does ubrogepant compare to monoclonal antibody treatments?
A2: Ubrogepant offers oral, rapidly acting relief for acute attacks, contrasting with injectable preventive mAbs. It appeals to patients seeking convenience and immediate relief.

Q3: What threats could impact ubrogepant’s financial outlook?
A3: Patent expiration, intensifying competition, biosimilar entry, and potential regulatory changes.

Q4: What are the key regulatory milestones anticipated for ubrogepant?
A4: European EMA approval (expected 2024), Japanese NDA review completion, and potential indications expansion.

Q5: How does the pricing strategy influence market penetration?
A5: Competitive pricing, aligned with perceived value, enhances access; however, payer pressure may necessitate discounts or value-based arrangements.

Key Takeaways

• Ubrogepant remains a leading oral CGRP receptor antagonist for migraine acute treatment, with robust sales growth fueled by expanding approvals and market demand.
• The global migraine market is growing at a double-digit CAGR (~12%), projected to reach over $1.2 billion by 2027.
• Patent and competitive challenges necessitate strategic focus on pipeline expansion, regional launches, and payer negotiations.
• Regulatory progress outside the US, particularly in Europe and Japan, will be critical for long-term revenue expansion.
• The competitive landscape includes oral small molecules and injectable monoclonal antibodies; differentiation depends on efficacy, safety, convenience, and pricing.

Citations

1. EvaluatePharma, "Migraine Market Forecast," 2022.
2. FDA, "Ubrogepant (Ubrelvy) NDA Approval Letter," 2019.
3. Biohaven Pharmaceuticals, "Rimegepant Clinical Data," 2022.
4. Allergan (AbbVie), "Ubrelvy Product Profile," 2023.
5. European Medicines Agency, "Regulatory filings," 2023.

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(This document aims to inform business and investment decisions regarding ubrogepant, leveraging market data, clinical development information, and strategic insights for comprehensive analysis.)