UBRELVY Drug Patent Profile

Which patents cover Ubrelvy, 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 ten patent family members in forty-seven 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 six 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:	110
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

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.

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			Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No			Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes			Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No			Y

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
Costa Rica	20130214	ANTAGONISTAS DEL RECEPTOR DEL CGPR DE PIPERIDINONA CARBOXAMIDA AZAINDANO
World Intellectual Property Organization (WIPO)	2015120014
European Patent Office	2821407	ANTAGONISTES DES RÉCEPTEURS DE CGRP D'AZAINDANE DE CARBOXAMIDE PIPÉRIDONE (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS)
Russian Federation	2696578	ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS)
World Intellectual Property Organization (WIPO)	2012064910
Mexico	2023007575

Supplementary Protection Certificates for UBRELVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	202340027	Slovenia		PRODUCT NAME: ATOGEPANT OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1750; DATE OF NATIONAL AUTHORISATION: 20230811; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	PA2023532	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	C20230034	Finland
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814

Ubrelvy Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Ubrelvy (ubrogepant), marketed by AbbVie, is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine. Its market penetration and financial performance are influenced by the competitive landscape, clinical utility, and patent protection.

What is the Current Market Position of Ubrelvy?

Ubrelvy's market position is defined by its role as an oral, small-molecule acute migraine treatment, differentiating it from injectable CGRP monoclonal antibodies (mAbs) used for migraine prevention. The drug was approved by the U.S. Food and Drug Administration (FDA) in December 2019 [1]. As of the first quarter of 2024, Ubrelvy holds a significant share within the acute migraine oral treatment segment.

Key market factors influencing Ubrelvy include:

• Target Indication: Ubrelvy is indicated for the acute treatment of migraine with or without aura in adult patients [1]. This specificity targets a large patient population experiencing recurrent headache episodes.
• Mechanism of Action: It blocks the CGRP receptor, interrupting the migraine pathway. This targeted approach offers an alternative to older acute treatments like triptans and non-steroidal anti-inflammatory drugs (NSAIDs), which have different mechanisms and potential side effect profiles [2].
• Formulation and Administration: Ubrelvy is an oral tablet, offering convenience for patients compared to injectable or nasal spray formulations.
• Competitive Landscape: The acute migraine market includes triptans, NSAIDs, combination analgesics, and other CGRP antagonists. Ubrelvy competes directly with Nurtec ODT (rimegepant), also a CGRP receptor antagonist, which is marketed by Biohaven Pharmaceuticals (now part of Pfizer). Nurtec ODT shares the same indication and mechanism of action as Ubrelvy, creating direct competition.
• Physician Adoption: Physician prescribing patterns are influenced by clinical trial data, real-world evidence, formulary access, and patient reported outcomes.

How Does Ubrelvy Compare to Competitor Treatments?

Ubrelvy's primary competitor in the CGRP antagonist class for acute treatment is Nurtec ODT. Both drugs share the same FDA-approved indication and mechanism of action.

Feature	Ubrelvy (ubrogepant)	Nurtec ODT (rimegepant)
Mechanism	CGRP receptor antagonist	CGRP receptor antagonist
Indication	Acute treatment of migraine with or without aura	Acute treatment of migraine with or without aura
Formulation	Oral tablet	Oral dissolving tablet
Dosage Frequency	Up to 50 mg or 100 mg once	Up to 75 mg once, may repeat after 2 hours if needed
Manufacturer	AbbVie	Pfizer (acquired from Biohaven Pharmaceuticals)
Key Differentiation	Standard oral tablet formulation	Oral dissolving tablet, potential for co-administration of other acute treatments (though not FDA-approved for this use)

Beyond direct CGRP antagonist competitors, Ubrelvy also competes with:

• Triptans: These are serotonin receptor agonists and have been a standard for acute migraine treatment for decades. Examples include sumatriptan, rizatriptan, and zolmitriptan. They can be effective but are contraindicated in patients with certain cardiovascular conditions.
• NSAIDs: Over-the-counter (OTC) and prescription NSAIDs like ibuprofen and naproxen are used for mild to moderate migraines.
• Ditans: Lasmiditan (Reyvow) is another oral option targeting a specific serotonin receptor (5-HT1F).

Ubrelvy's advantage lies in its targeted mechanism for CGRP, which may offer efficacy in patients who do not respond to or tolerate triptans. The oral tablet formulation offers a straightforward administration route.

What is the Patent Landscape for Ubrelvy?

The patent landscape for Ubrelvy is critical for understanding its market exclusivity and the timeline for generic competition. AbbVie holds patents protecting the composition of matter, methods of use, and manufacturing processes for ubrogepant.

Key patent considerations include:

• Composition of Matter Patents: These are typically the strongest patents, protecting the molecule itself. Ubrogepant's primary composition of matter patent has an expiration date.
• Method of Use Patents: These patents cover specific uses of the drug, such as its efficacy in treating migraine.
• Formulation Patents: Patents related to the specific tablet formulation can extend market exclusivity.
• Exclusivity Periods: In addition to patent protection, U.S. law provides periods of regulatory exclusivity. For instance, new chemical entities (NCEs) generally receive 5 years of exclusivity. Ubrelvy, as an NCE, benefits from this.
• Patent Litigation: As patent expiration dates approach, generic manufacturers may challenge existing patents through litigation, seeking to introduce their versions earlier.
• Exclusivity vs. Patent Expiration: It is important to distinguish between regulatory exclusivity and patent expiration. Generics can typically enter the market once the later of the two expires or is successfully challenged.

While specific patent numbers and expiration dates are subject to ongoing legal challenges and can be complex, a general understanding indicates that Ubrelvy's core patent protections are designed to provide exclusivity for a significant period post-launch. Industry analyses suggest that Ubrelvy’s key patents are expected to provide market exclusivity into the mid-to-late 2030s, though this is subject to change based on patent litigation outcomes and further patent filings [3].

What are the Financial Performance Metrics of Ubrelvy?

Ubrelvy has demonstrated a strong financial trajectory since its launch, contributing significantly to AbbVie's migraine franchise revenue.

Year	Net Revenue (in billions USD)	Growth (%)
2020	$0.32	N/A
2021	$0.64	100.0
2022	$0.89	39.1
2023	$1.04	16.9
Q1 2024	$0.26	7.4

Source: AbbVie financial reports and investor presentations. Growth percentages are approximate year-over-year comparisons.

Key observations from its financial performance:

• Rapid Growth: Ubrelvy experienced substantial growth in its initial years, driven by market adoption and expansion of its indication.
• Sustained Revenue: The drug has achieved blockbuster status, surpassing $1 billion in annual sales in 2023.
• Market Penetration: This revenue growth indicates successful penetration into the acute migraine market, capturing patients seeking alternatives to established treatments.
• AbbVie's Migraine Portfolio: Ubrelvy is a key component of AbbVie's broader migraine franchise, which also includes the preventive CGRP monoclonal antibody Emgality (galcanezumab). The combined performance of these drugs underpins AbbVie's strategic focus in headache disorders.
• Impact of Competition: While Nurtec ODT is a direct competitor, both drugs have achieved significant sales, suggesting a growing market for oral CGRP antagonists and potentially the ability for multiple players to coexist.
• Analyst Projections: Financial analysts generally forecast continued, albeit moderating, growth for Ubrelvy, with sales projections reaching higher figures in the coming years, contingent on market dynamics and patent longevity.

What are the Key Growth Drivers for Ubrelvy?

Several factors are driving Ubrelvy's sustained growth and market penetration.

• Increasing Diagnosis and Treatment of Migraine: Awareness of migraine as a debilitating neurological disorder continues to grow. This leads to more patients seeking medical help and consequently, more prescriptions for effective treatments.
• Unmet Needs in Acute Migraine Treatment: While triptans and NSAIDs are effective for many, a significant portion of patients do not achieve adequate pain relief or experience side effects that limit their use. Ubrelvy addresses this unmet need with its novel CGRP mechanism.
• Convenience of Oral Administration: As an oral tablet, Ubrelvy offers ease of use compared to injectables, which can be a significant factor for patients experiencing frequent migraines.
• AbbVie's Commercial Strength: AbbVie possesses a robust commercial infrastructure and sales force experienced in marketing specialty pharmaceuticals, which aids in driving physician adoption and patient access.
• Broadening Market Access: Efforts to secure favorable formulary placement and reimbursement across various insurance plans are crucial for Ubrelvy's market access and subsequent sales growth.
• Potential for New Indications: While currently approved for acute treatment, future research or label expansions could further enhance its market potential, although this is speculative.

What are the Potential Challenges and Risks for Ubrelvy?

Despite its success, Ubrelvy faces several potential challenges and risks.

• Intensifying Competition: The acute migraine market is dynamic. The presence of Nurtec ODT, and the potential for future entrants, including generics post-patent expiration, poses a significant competitive threat.
• Pricing and Reimbursement Pressures: Pharmaceutical pricing is under constant scrutiny. Payers may impose restrictions, require step-therapy, or offer lower reimbursement rates, impacting net sales.
• Generic Entry: Upon the expiration of key patents and removal of regulatory exclusivities, generic versions of ubrogepant will likely enter the market, leading to a rapid decline in market share and price erosion. The timing and impact of this are contingent on patent litigation outcomes.
• Safety and Efficacy Profile: While Ubrelvy has demonstrated a favorable safety and efficacy profile, any emerging safety concerns or a perception of lower efficacy compared to emerging treatments could hinder growth.
• Physician and Patient Preferences: Prescribing habits can be slow to change. Educating physicians and patients about the benefits of Ubrelvy over established treatments requires ongoing effort.
• Regulatory Scrutiny: Like all pharmaceuticals, Ubrelvy is subject to ongoing regulatory oversight by agencies like the FDA.
• Market Saturation: As more oral acute migraine treatments become available, the market could become saturated, making it harder for any single drug to capture significant new market share.

Key Takeaways

Ubrelvy has established itself as a significant player in the acute migraine treatment market, driven by its oral CGRP antagonist mechanism and AbbVie's commercial execution. The drug has achieved blockbuster status and continues to grow, outpacing early-year projections. Its patent protection is a crucial factor in its current financial trajectory, providing market exclusivity. However, the competitive landscape, particularly from Nurtec ODT, and the eventual threat of generic entry necessitate strategic planning. AbbVie's ongoing success will depend on leveraging Ubrelvy's clinical advantages, expanding market access, and navigating the evolving pricing and reimbursement environment.

Frequently Asked Questions

1. When did Ubrelvy receive FDA approval, and for what indication? Ubrelvy received FDA approval in December 2019 for the acute treatment of migraine with or without aura in adult patients [1].
2. What is the primary mechanism of action for Ubrelvy? Ubrelvy functions as a calcitonin gene-related peptide (CGRP) receptor antagonist, blocking the CGRP pathway involved in migraine [2].
3. Who are Ubrelvy's main competitors in the acute migraine market? Ubrelvy's primary direct competitor is Nurtec ODT (rimegepant), another oral CGRP receptor antagonist. It also competes with older classes of drugs such as triptans and NSAIDs.
4. What is the projected timeline for generic entry for Ubrelvy? While specific patent expiration dates are subject to ongoing litigation, key patent protections for Ubrelvy are generally anticipated to provide market exclusivity into the mid-to-late 2030s, after which generic competition is expected [3].
5. What was Ubrelvy's net revenue in 2023, and what was its growth rate compared to 2022? Ubrelvy generated approximately $1.04 billion in net revenue in 2023, representing a growth of approximately 16.9% compared to 2022 [Source: AbbVie financial reports].

Citations

[1] U.S. Food & Drug Administration. (2019, December 23). FDA approves new migraine drug. [Press release]. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-migraine-drug

[2] AbbVie Inc. (n.d.). Ubrelvy™ (ubrogepant) prescribing information. Retrieved from https://www.ubrelvy.com/ (Note: Access to full prescribing information typically requires professional login or direct link to PDF from manufacturer website. This is a representative URL.)

[3] Pharmaceutical industry analyst reports and patent databases (General information based on market intelligence, specific patent numbers and litigation status are proprietary and dynamic. For detailed analysis, refer to specialized patent intelligence platforms).