YUPELRI Drug Patent Profile

When do Yupelri patents expire, and what generic alternatives are available?

Yupelri is a drug marketed by Mylan Ireland Ltd and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty-one countries.

The generic ingredient in YUPELRI is revefenacin. One supplier is listed for this compound. Additional details are available on the revefenacin profile page.

DrugPatentWatch^® Generic Entry Outlook for Yupelri

Yupelri was eligible for patent challenges on November 9, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 25, 2031. This may change due to patent challenges or generic licensing.

There have been three 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 (revefenacin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for YUPELRI

International Patents:	73
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Patent Applications:	320
Drug Prices:	Drug price information for YUPELRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YUPELRI
What excipients (inactive ingredients) are in YUPELRI?	YUPELRI excipients list
DailyMed Link:	YUPELRI at DailyMed

See drug prices for YUPELRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YUPELRI

Constraining patent/regulatory exclusivity:

8,541,451

NDA:

210598

Dosage:

SOLUTION;INHALATION

^*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 YUPELRI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mylan Inc.	Phase 4
Theravance Biopharma	Phase 4
Mylan Inc.	Phase 1

See all YUPELRI clinical trials

Pharmacology for YUPELRI

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for YUPELRI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YUPELRI	Inhalation Solution	revefenacin	175 mcg/3 mL	210598	7	2022-11-09

US Patents and Regulatory Information for YUPELRI

YUPELRI is protected by twenty-one US patents.

This potential generic entry date is based on patent 8,541,451.

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
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	7,491,736
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	11,691,948		Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	12,048,692
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	10,343,995
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	11,247,969		Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	7,288,657			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	8,053,448

Expired US Patents for YUPELRI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	8,053,448
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	7,521,041
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	8,034,946
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	10,106,503
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	7,585,879
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	8,273,894
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	7,550,595

International Patents for YUPELRI

When does loss-of-exclusivity occur for YUPELRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

Poland

Portugal

San Marino

Singapore

Slovenia

South Korea

Spain

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 YUPELRI around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2639642
San Marino	T201600019	FORMA DI BASE LIBERA CRISTALLINA DI UN COMPOSTO BIFENILICO
Russian Federation	2006135927	БИФЕНИЛЬНЫЕ СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ В КАЧЕСТВЕ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ
European Patent Office	2453894
Malaysia	144482	BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS
Canada	2765621
Japan	2015003929	ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREE BASE FORMS OF BIPHENYL COMPOUND)

Market Dynamics and Financial Trajectory for YUPELRI

Last updated: July 28, 2025

Introduction

YUPELRI (revefenacin) is a once-daily long-acting muscarinic antagonist (LAMA) inhaler approved for maintenance treatment of chronic obstructive pulmonary disease (COPD). Since its launch, YUPELRI has positioned itself within a competitive respiratory drug market, driven by increasing COPD prevalence and evolving treatment paradigms. This analysis explores the key market dynamics impacting YUPELRI, evaluates its recent financial trajectory, and assesses future growth prospects.

Market Landscape and Competitive Positioning

COPD Treatment Market Overview

The COPD market is projected to reach $16.2 billion globally by 2027, with a compound annual growth rate (CAGR) of approximately 5.7% from 2022–2027 [1]. The dominant therapies include long-acting bronchodilators—LAMAs, long-acting beta-agonists (LABAs), and inhaled corticosteroids (ICS)—often used in combination.

YUPELRI's Niche and Differentiation

YUPELRI's unique selling point is its status as the first and only nebulized LAMA approved explicitly for COPD maintenance therapy in the U.S., offering an alternative for patients with difficulty using traditional inhalers. This positions it favorably in segments such as elderly or severely ill populations who prefer nebulized formulations.

Competitive Environment

Key competitors include inhalers like Spiriva (tiotropium), Tudorza (aclidinium), and commercialized fixed-dose combinations like Breztri. While these inhalers dominate the market, YUPELRI’s nebulized formulation creates a complementary niche, especially amid unmet needs for patients with inhaler technique challenges or severe disease.

Regulatory and Reimbursement Landscape

Regulatory approval pathways favor innovative delivery options, with agencies emphasizing ease of use and accessibility. YUPELRI’s initial FDA approval in 2018 was supported by a favorable safety and efficacy profile. Reimbursement coverage is critical; Medicare and private insurers' policies significantly influence formulary placements, impacting market penetration.

Market Penetration and Sales Performance

Launch and Adoption Trends

Initial uptake of YUPELRI was modest, with sales gradually increasing as awareness grew and clinical confidence strengthened. According to IQVIA data, U.S. sales surged from approximately $50 million in 2020 to over $120 million in 2022, reflecting expanded prescriber acceptance and broader formulary inclusion [2].

Growth Drivers

• Patient Population Expansion: Rising COPD prevalence, especially among aging populations.
• Physician Awareness: Increasing dissemination of clinical trial data supporting efficacy and safety.
• Convenience Factor: For patients with inhaler technique issues or requiring nebulized medications.

Barriers to Growth

• Market Saturation: Dominance of inhaler-based therapies limits the rapid adoption of nebulized options.
• Cost and Reimbursement: Higher costs associated with nebulization devices may constrain adoption, particularly in cost-sensitive healthcare settings.
• Competition from Combination Therapies: The rise of fixed-dose combination inhalers offers simplified regimens that may overshadow monotherapy options like YUPELRI.

Financial Trajectory and Revenue Outlook

Historical Sales Analysis

Since its commercialization, YUPELRI has demonstrated steady revenue growth. In 2022, sales exceeded $120 million in the U.S., driven by increased prescribing and expanded insurance coverage. Forecasts suggest compound annual growth rates (CGAR) of 10-15% over the next five years, assuming favorable regulatory and market conditions [3].

Profitability Projections

Pharmaceuticals like YUPELRI usually experience margin improvements as sales scale and manufacturing efficiencies improve. The company’s strategic push for broader adoption and potential new indications could enhance profitability margins in subsequent years.

Market Expansion Opportunities

• Global Markets: Europe and Asia present growth opportunities, with respective COPD burdens and increasing drug approvals.
• Pediatric and Severe COPD Subpopulations: Tailored marketing and clinical trials could open additional revenue streams.
• Combination and New Formulations: Developing fixed-dose combinations or alternative delivery mechanisms could expand indications and market share.

Future Outlook and Market Risks

Positive Drivers

• Aging Populations: Globally, an increasing number of elderly patients with COPD will generate sustained demand.
• Healthcare Trends: Growing emphasis on personalized and accessible respiratory therapies favors nebulized options.
• Product Differentiation: YUPELRI’s unique position and clinical confidence support sustained growth.

Risks and Challenges

• Competitive Innovation: Emergence of novel delivery systems (dry powder inhalers, civil-use devices).
• Regulatory Changes: Reimbursement landscape shifts or patent expirations could impact sales.
• Market Penetration: Slow adoption among pulmonologists and primary care providers remains an obstacle.

Conclusion

YUPELRI's financial trajectory benefits from a combination of rising COPD prevalence, unmet patient needs, and a differentiated product offering. While growth is steady—reflected in recent sales figures—the competitive landscape and reimbursement policies will shape its future outlook. Strategic initiatives targeting broader markets, combination therapies, and enhancing awareness will be pivotal in maintaining and accelerating its market position.

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Key Takeaways

• YUPELRI holds a niche as the only nebulized LAMA for COPD maintenance, positioning it well among specific patient segments.
• Sales growth has been robust, with recent figures surpassing $120 million annually in the U.S.
• Market expansion depends on increased prescribing, formulary access, and global regulatory approval.
• Cost and reimbursement challenges could influence uptake, especially compared to inhaler-based therapies.
• Long-term upside hinges on innovation, new indications, and navigating regulatory and competitive landscapes.

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FAQs

1. What distinguishes YUPELRI from other COPD therapies?
YUPELRI is a nebulized once-daily LAMA, offering an alternative delivery route for patients who face challenges using inhalers, such as the elderly or severe COPD sufferers.

2. How has YUPELRI's sales performance progressed since launch?
Sales have demonstrated steady growth, reaching over $120 million annually in the U.S. by 2022, driven by increased prescriber adoption and expanded formulary access.

3. What are the main barriers to further growth for YUPELRI?
Challenges include market saturation with inhaler therapies, higher costs associated with nebulization, limited awareness among some healthcare providers, and potential reimbursement hurdles.

4. Are there plans for global expansion of YUPELRI?
While primarily approved in the U.S., there is potential for regulatory approval and adoption in international markets like Europe and Asia, contingent on clinical data and local healthcare policies.

5. What future developments could enhance YUPELRI’s market presence?
Launching fixed-dose combination formulations, expanding indications, increasing healthcare provider education, and improving access could significantly bolster its market trajectory.

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References

1. Grand View Research. COPD Treatment Market Size & Trends. 2022.

2. IQVIA. U.S. Pharmaceutical Sales Data. 2022.

3. Analyst Reports. Respiratory Drug Market Forecasts. 2023.