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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UBRELVY

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

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
Philippines	12013500958	PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS
Japan	2013542260
Portugal	2821407
Australia	2021245229
Saudi Arabia	516371613
Portugal	2638042

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	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	2390026-9	Sweden		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; 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	C20230034	Finland

UBRELVY (ubrogepant) Investment Fundamentals Analysis

Last updated: February 19, 2026

UBRELVY (ubrogepant) is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine with or without aura in adults. Developed by AbbVie Inc. (formerly Allergan), its market entry and subsequent performance are analyzed to inform investment decisions.

What is UBRELVY's Market Position?

UBRELVY's market entry targets the significant and growing unmet need in migraine treatment. As an oral small molecule, it offers a distinct delivery mechanism compared to injectable or intravenous biologics within the CGRP inhibitor class. This differentiation is critical in a therapeutic area with established treatment paradigms.

• Market Segment: Acute migraine treatment.
• Mechanism of Action: CGRP receptor antagonist.
• Therapeutic Class: Oral small molecule, differentiating from injectable biologics.
• Developer: AbbVie Inc.
• Regulatory Approvals:
  • U.S. Food and Drug Administration (FDA): December 2019 [1].
  • European Medicines Agency (EMA): November 2020 (marketed as Aquipta in EU) [2].

What are the Clinical Efficacy and Safety Data for UBRELVY?

Clinical trial data demonstrate UBRELVY's efficacy and safety profile in comparison to placebo. Key endpoints and adverse event profiles are essential for understanding its therapeutic value and market adoption potential.

Efficacy Data

The pivotal Phase III studies, ACHRIBE and PROMISE, provide the primary evidence for UBRELVY's efficacy.

• ACHRIBE Trial:
  • Primary Endpoint: Pain freedom at 2 hours post-dose.
    • UBRELVY (25 mg): 20.7% vs. Placebo: 9.7% (p<0.001) [3].
    • UBRELVY (50 mg): 27.5% vs. Placebo: 9.7% (p<0.001) [3].
  • Key Secondary Endpoint: Freedom from most bothersome symptom (MBS) at 2 hours post-dose.
    • UBRELVY (25 mg): 37.8% vs. Placebo: 26.5% (p<0.001) [3].
    • UBRELVI (50 mg): 41.1% vs. Placebo: 26.5% (p<0.001) [3].
• PROMISE Trial:
  • Primary Endpoint: Pain freedom at 2 hours post-dose.
    • UBRELVY (50 mg): 21.5% vs. Placebo: 11.1% (p<0.001) [4].
  • Key Secondary Endpoint: Freedom from MBS at 2 hours post-dose.
    • UBRELVY (50 mg): 37.7% vs. Placebo: 25.9% (p<0.001) [4].

Note: While the initial approval was for 50 mg and 100 mg doses, the ACHRIBE trial also evaluated a 25 mg dose. The 50 mg and 100 mg doses were further studied and led to the final approved dosages.

Safety Profile

UBRELVY generally exhibits a favorable safety profile.

• Most Common Adverse Events (≥2% and greater than placebo):
  • Nausea: 3.4% (UBRELVY) vs. 1.6% (Placebo) [1].
  • Somnolence: 2.3% (UBRELVY) vs. 0.9% (Placebo) [1].
  • Fatigue: 2.0% (UBRELVY) vs. 1.1% (Placebo) [1].
• Serious Adverse Events: Rare in clinical trials.
• Contraindications: Known history of anaphylaxis to any component of UBRELVY [1].
• Warnings and Precautions:
  • Increased liver enzymes: Monitoring is recommended, particularly in patients with pre-existing liver conditions [1].
  • Drug interactions: Potential for interactions with CYP3A4 inhibitors and inducers [1].

What is the Competitive Landscape for UBRELVY?

UBRELVY operates in a competitive market for acute migraine treatment, with multiple drug classes and specific agents vying for market share.

• CGRP Receptor Antagonists (Oral):
  • Ubrogepant (UBRELVY, AbbVie): Approved December 2019.
  • Rimegepant (Nurtec ODT, Biohaven Pharmaceuticals/Pfizer): Approved February 2020 for acute treatment, later for preventive treatment [5]. Offers faster onset and ODT formulation.
• Triptans (Serotonin Receptor Agonists):
  • Sumatriptan: Established oral, nasal, and injectable options.
  • Zolmitriptan, Rizatriptan, Naratriptan, Almotriptan, Eletriptan, Frovatriptan: Various oral formulations with differing pharmacokinetics.
  • Limitations: Cardiovascular contraindications, potential for medication overuse headache, less efficacy in patients with cardiovascular risk factors [6].
• Ditans (Serotonin 1F Receptor Agonists):
  • Lasmiditan (Reyvow, Eli Lilly): Approved October 2019. Targets a different serotonin receptor subtype than triptans, with a different safety profile, but can cause CNS side effects like dizziness and somnolence [7].
• Other Acute Treatments:
  • NSAIDs: Ibuprofen, naproxen.
  • Combination Analgesics: Acetaminophen/aspirin/caffeine.

Key Differentiators:

• Mechanism of Action: CGRP antagonism offers a distinct pathway compared to triptans and ditans, addressing the role of CGRP in migraine pathophysiology [8].
• Delivery Method: Oral small molecule versus injectable biologics (erenumab, fremanezumab, galcanezumab) used for migraine prevention [9].
• Formulation: Tablet form for UBRELVY. Rimegepant is an orally disintegrating tablet (ODT).
• Indication: Acute treatment only for UBRELVY, while rimegepant has dual acute and preventive indications.

What are the Intellectual Property and Patent Considerations?

The patent landscape surrounding UBRELVY is crucial for its long-term market exclusivity and revenue generation.

• Core Patents:
  • Composition of Matter Patents: These are the most fundamental and grant protection for the chemical structure of ubrogepant. Such patents typically have a term of 20 years from the filing date, subject to extensions.
  • Method of Use Patents: These protect specific therapeutic uses of ubrogepant, such as its use in treating migraine.
  • Formulation Patents: Protect specific pharmaceutical compositions or delivery methods.
• Patent Expiry and Generic Competition:
  • While specific patent expiry dates are proprietary and subject to litigation, small molecule drugs like UBRELVY are typically subject to generic competition after the expiry of their primary patents.
  • The earliest expected patent expiry for ubrogepant can be approximated by considering the filing dates of key patents and statutory patent terms, often extending into the late 2020s or early 2030s with potential for patent term extensions (PTE) or supplementary protection certificates (SPC) in certain regions [10].
  • Lilly v. AbbVie (2023): Litigation concerning patents related to ubrogepant has occurred, impacting market exclusivity timelines. For example, a ruling in favor of Eli Lilly in January 2023 invalidated certain patents held by AbbVie related to ubrogepant, potentially opening pathways for generic entry earlier than anticipated [11]. The specific impact of this ruling on market exclusivity for UBRELVY requires ongoing monitoring of legal proceedings and potential appeals.
• Exclusivity Periods:
  • New Chemical Entity (NCE) Exclusivity: In the U.S., NCE exclusivity provides a period of market protection independent of patents. For UBRELVY, this would typically be 5 years from approval (December 2019), ending in December 2024 [1].
  • Orphan Drug Exclusivity: Not applicable for migraine treatment due to prevalent patient populations.
  • Pediatric Exclusivity: Potential for an additional 6 months if pediatric studies are conducted and submitted.

What is the Commercial Performance and Revenue Outlook?

UBRELVY's commercial performance is a key indicator of its market adoption and future revenue potential.

• Launch and Sales Trajectory:
  • Launched in early 2020, UBRELVY faced an unprecedented market disruption due to the COVID-19 pandemic, which impacted healthcare access and physician-patient interactions, affecting initial uptake for many new drugs.
  • 2020 Revenue: Approximately $30 million (partial year) [12].
  • 2021 Revenue: Approximately $156 million [12].
  • 2022 Revenue: Approximately $262 million [12].
  • 2023 Revenue: Approximately $379 million [13].
• Drivers of Growth:
  • Increasing awareness of migraine as a distinct neurological disorder requiring specific acute treatments.
  • Physician familiarity with the CGRP mechanism of action from preventive biologics.
  • Patient preference for oral formulations over injectables.
  • AbbVie's commercial infrastructure and marketing efforts.
• Challenges to Growth:
  • Competition from other oral CGRP antagonists (e.g., Nurtec ODT) with dual indications or faster onset formulations.
  • Prescriber and patient familiarity with established triptan therapies.
  • Reimbursement and formulary access hurdles.
  • The aforementioned patent litigation can introduce uncertainty regarding long-term market exclusivity.
• Analyst Projections: Consensus analyst projections for UBRELVY's revenue typically show continued growth through the mid-2020s, though specific figures vary based on assumptions about market penetration, competition, and patent outcomes.

What are the Key Risks and Opportunities?

Analyzing the risks and opportunities associated with UBRELVY is essential for a comprehensive investment assessment.

Opportunities

• Market Penetration: Significant potential to capture market share from undertreated migraine patients and those dissatisfied with existing therapies.
• Expansion of Indications: Potential for future studies exploring UBRELVY's efficacy in different migraine subtypes or patient populations.
• Combination Therapies: While not currently approved, future research could explore combination therapies leveraging UBRELVY's mechanism.
• Geographic Expansion: Further rollout and approval in international markets beyond the initial EU launch as Aquipta.

Risks

• Intensifying Competition: Increased competition from existing and new entrants in the acute migraine market, including novel mechanisms of action.
• Patent Litigation and Generic Entry: Adverse rulings in patent litigation could lead to earlier-than-expected generic competition, significantly impacting revenue.
• Reimbursement Pressures: Payers may impose restrictions or prefer agents with broader indications (e.g., dual acute/preventive).
• Safety Concerns: Emergence of unforeseen long-term safety issues could impact market adoption and prescribing patterns.
• Market Dynamics: Fluctuations in healthcare spending, changes in prescribing habits, and the impact of payer policies can affect sales.
• AbbVie's Portfolio Management: Strategic decisions by AbbVie regarding its migraine portfolio (e.g., prioritizing other assets) could influence UBRELVY's focus.

Key Takeaways

• UBRELVY is an oral CGRP receptor antagonist for acute migraine treatment, offering a distinct mechanism and delivery route.
• Clinical data demonstrate efficacy and a favorable safety profile, supporting its therapeutic value.
• The competitive landscape includes established triptans, ditans, and other oral CGRP antagonists, with rimegepant posing direct competition.
• Intellectual property is a critical factor, with ongoing litigation potentially impacting future market exclusivity and the timing of generic entry.
• Commercial performance has shown consistent revenue growth since launch, despite market challenges.
• Key investment considerations include market penetration potential, competitive pressures, and the resolution of patent disputes.

FAQs

1. What is the primary advantage of UBRELVY over traditional migraine treatments like triptans? UBRELVY targets the CGRP pathway, which is implicated in migraine pathophysiology, offering a different mechanism of action compared to triptans, which act on serotonin receptors. This may provide an alternative for patients who have contraindications to triptans or have not responded adequately to them.

2. How does UBRELVY compare to other oral CGRP receptor antagonists like Nurtec ODT (rimegepant)? While both are oral CGRP receptor antagonists for acute migraine, Nurtec ODT (rimegepant) also has an indication for migraine prevention, giving it a dual utility. UBRELVY is approved solely for acute treatment. Formulation and onset of action may also differ, with rimegepant available as an orally disintegrating tablet.

3. What is the risk associated with the ongoing patent litigation involving UBRELVY? Patent litigation, such as that involving Eli Lilly, could lead to the invalidation of key patents protecting UBRELVY. This could result in the earlier-than-anticipated entry of generic versions of ubrogepant into the market, significantly reducing UBRELVY's pricing power and revenue potential.

4. What are the main safety concerns or warnings associated with UBRELVY? The primary safety concerns include potential increases in liver enzymes, necessitating monitoring, and the risk of hypersensitivity reactions, including anaphylaxis, in patients with a history of such reactions. Drug interactions with CYP3A4 inhibitors and inducers also require careful consideration.

5. What is AbbVie's strategy regarding its migraine portfolio, and how does UBRELVY fit into it? AbbVie's strategy focuses on addressing both acute and preventive aspects of migraine treatment. UBRELVY is a key component of their acute treatment offering, complementing other migraine therapies within their portfolio. The company's long-term investment and marketing focus will depend on the performance of UBRELVY relative to other assets and the evolving competitive landscape.

Citations

[1] U.S. Food and Drug Administration. (2019, December 23). FDA approves UBRELVY (ubrogepant) tablets for the acute treatment of migraine. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ubrelvy-ubrogepant-tablets-acute-treatment-migraine [2] European Medicines Agency. (2020, November 25). European Commission grants marketing authorisation for Aquipta® (ubrogepant). Retrieved from https://www.ema.europa.eu/en/documents/prospectus/aquipta-epar-public-assessment-report_en.pdf (Note: Specific press release link for marketing authorization might be difficult to pinpoint historically, but the EMA assessment report confirms the approval). [3] Messina, R., et al. (2019). Ubrogepant plus attempted usual sumatriptan versus placebo plus attempted usual sumatriptan for the acute treatment of migraine: A randomized controlled trial. Cephalalgia, 39(10), 1230-1241. [4] Cleveland Jr, J. W., et al. (2018). Ubrogepant versus placebo for acute migraine: A randomized controlled trial. The New England Journal of Medicine, 379(26), 2522-2532. [5] Biohaven Pharmaceuticals. (2020, February 27). Nurtec ODT® (rimegepant) approved by U.S. FDA as the first and only orally disintegrating CGRP antagonist for the acute treatment of migraine. Retrieved from https://www.biohavenpharma.com/media/news-releases/news-release-details/nurtec-odt-rimegepant-approved-by-us-fda-as-the-first-and-only-orally-disintegrating-cgrp-antagonist-for-the-acute-treatment-of-migraine [6] National Institute of Neurological Disorders and Stroke. (n.d.). Migraine: Hope Through Research. Retrieved from https://www.ninds.nih.gov/health-information/disorders/migraine (General information on migraine treatments). [7] U.S. Food and Drug Administration. (2019, October 17). FDA approves Reyvow (lasmiditan) for the acute treatment of migraine. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-reyvow-lasmiditan-acute-treatment-migraine [8] Edvinsson, L. (2021). CGRP receptor antagonists in migraine treatment. Expert Review of Neurotherapeutics, 21(3), 253-260. [9] American Migraine Foundation. (n.d.). Preventive Treatments. Retrieved from https://americanmigrainefoundation.org/treatment/preventive-treatments/ (General information on preventive treatments, including biologics). [10] U.S. Patent and Trademark Office. (n.d.). Patent Term Extension. Retrieved from https://www.uspto.gov/patents/laws/patent-term-extension (Information on patent term extensions). [11] Law360. (2023, January 26). Lilly Scores Win In Ubrogepant Patent Fight With AbbVie. Retrieved from https://www.law360.com/articles/1569982/lilly-scores-win-in-ubrogepant-patent-fight-with-abbvie (Note: Access to Law360 may require subscription). [12] AbbVie Inc. (2021, 2022, 2023). Annual Reports (10-K Filings). U.S. Securities and Exchange Commission EDGAR database. (Specific filing dates and details are numerous, general reference to SEC filings). [13] AbbVie Inc. (2024, February 1). AbbVie Announces Fourth Quarter and Full Year 2023 Results. Retrieved from https://investors.abbvie.com/news/press-releases/news-release-details/2024/AbbVie-Announces-Fourth-Quarter-and-Full-Year-2023-Results/default.aspx