UBRELVY Drug Patent Profile

Which patents cover Ubrelvy, and when can generic versions of Ubrelvy launch?

Ubrelvy is a drug marketed by Abbvie and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and four patent family members in forty-five 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 two 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.

Indicators of Generic Entry

Summary for UBRELVY

International Patents:	104
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Patent Applications:	148
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 thirteen 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	211765-001	Dec 23, 2019		RX	Yes	No	8,754,096		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	12,168,004		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,857,542
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	10,117,836		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	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
China	105939715	抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
World Intellectual Property Organization (WIPO)	2015119919
Taiwan	I487706
Japan	2019108366	ＣＧＲＰ活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS)
European Patent Office	3237412	FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS)
Slovenia	2638042

Supplementary Protection Certificates for UBRELVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814

Market Dynamics and Financial Trajectory for Ubrelvy

Introduction to Ubrelvy

Ubrelvy, developed by AbbVie, is a significant player in the calcitonin gene-related peptide (CGRP) class of migraine treatments. It is specifically designed for the acute relief of migraine attacks and has been gaining traction in the market since its approval.

Market Growth and Projections

The migraine market is poised for substantial growth, driven largely by the increased prescription of CGRP antagonists. According to GlobalData, the migraine market across seven major markets (7MM) is expected to grow from $9.2 billion in 2023 to $16.4 billion by 2033, with a compound annual growth rate (CAGR) of 6.0%[4].

Competitive Landscape

Ubrelvy operates in a competitive landscape dominated by other CGRP antagonists. Biohaven’s Nurtec ODT, for instance, is a formidable competitor, approved for both acute and preventive therapy. Despite this, analysts from Evercore ISI suggest that Ubrelvy’s market share, although expected to decrease slightly due to Nurtec’s gains, will still remain significant. Evercore projects that Ubrelvy’s share of the CGRP acute market will fall from 38% to 31%, but the overall growth of the CGRP class will benefit both Ubrelvy and Nurtec[1].

Financial Performance

Recent Financial Results

In the third quarter of 2024, Ubrelvy reported net revenues of $269 million, representing a 15.3% increase from the previous year. This growth is part of a broader trend where AbbVie’s neuroscience portfolio, which includes Ubrelvy, saw a 15.6% increase in net revenues on a reported basis[2].

For the full year 2023, Ubrelvy’s net revenues were $234 million, an increase of 18.9% from the previous year. This indicates a consistent upward trajectory for the drug[5].

Peak Sales Projections

Analysts are optimistic about Ubrelvy’s long-term potential. Evercore ISI suggests that Ubrelvy could achieve peak sales of over $2 billion, surpassing AbbVie’s initial estimates of $1 billion. This optimism is fueled by the robust growth outlook for the CGRP class, with projected growth of 200% in the acute setting and 150% in the preventive setting over the next five years[1].

Market Drivers

Increasing Adoption of CGRP Antagonists

The CGRP class is gaining traction due to its efficacy and the growing awareness among healthcare providers. The survey of 25 neurologists by Evercore ISI indicates a strong preference for CGRP antagonists, which is expected to drive the market forward[1].

Comparative Advantage

Ubrelvy, as an oral gepant, offers a more convenient and potentially more effective treatment option compared to injectable CGRP treatments. This convenience factor is likely to contribute to its market share and growth[1].

Challenges and Limitations

Reimbursement Restrictions

One of the significant challenges facing CGRP antagonists, including Ubrelvy, is reimbursement restrictions. These drugs have higher annual costs compared to traditional treatments, which can limit their adoption due to reimbursement constraints[4].

Patent Expiries

The patent expiry dates for these drugs are a critical factor in their long-term financial trajectory. Ubrelvy, with one of the later patent expiry dates, is expected to remain a top-selling drug in the migraine market in 2033, with projected sales of $1.07 billion[4].

Impact of the Pandemic

The COVID-19 pandemic has had a mixed impact on pharmaceutical launches, including those in the migraine market. While some launches, like Wegovy and Nurtec, have performed exceptionally well, others have underperformed. However, Ubrelvy has been one of the exceptions, showing significant growth despite the pandemic challenges[3].

Expert Insights and Market Analysis

Analysts from Piper Sandler and Evercore ISI have been bullish on Ubrelvy’s prospects. Evercore’s Josh Schimmer noted that the peak sales potential for Ubrelvy could be closer to $2 billion-plus, indicating strong market confidence in the drug[1].

Key Takeaways

• Market Growth: The migraine market is expected to grow significantly, driven by CGRP antagonists.
• Financial Performance: Ubrelvy has shown consistent revenue growth, with a 15.3% increase in the third quarter of 2024.
• Peak Sales Projections: Analysts estimate peak sales of over $2 billion for Ubrelvy.
• Market Drivers: Increasing adoption of CGRP antagonists and the comparative advantage of oral gepants.
• Challenges: Reimbursement restrictions and patent expiries.

FAQs

Q: What is Ubrelvy used for? A: Ubrelvy is used for the acute relief of migraine attacks.

Q: How is the market for CGRP antagonists expected to grow? A: The market is expected to grow at a CAGR of 6.0% from $9.2 billion in 2023 to $16.4 billion by 2033.

Q: What are the peak sales projections for Ubrelvy? A: Analysts estimate peak sales of over $2 billion for Ubrelvy.

Q: What are the main challenges facing Ubrelvy in the market? A: Reimbursement restrictions and patent expiries are significant challenges.

Q: How has the COVID-19 pandemic affected the launch of Ubrelvy? A: Despite pandemic challenges, Ubrelvy has shown significant growth, unlike many other pharmaceutical launches.

Sources

1. FiercePharma: AbbVie's new migraine meds could each pull in $2B at peak thanks to growth in CGRP class, analysts say[1].
2. PR Newswire: AbbVie Reports Third-Quarter 2024 Financial Results[2].
3. IQVIA: Overcoming Pharma's Launch Performance Problem[3].
4. Clinical Trials Arena: Migraine market expected to reach $16.4bn across 7MM by 2033[4].
5. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[5].

Last updated: 2024-12-16