Revefenacin - Generic Drug Details

What are the generic sources for revefenacin and what is the scope of freedom to operate?

Revefenacin is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for revefenacin

International Patents:	73
US Patents:	21
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	19
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for revefenacin
What excipients (inactive ingredients) are in revefenacin?	revefenacin excipients list
DailyMed Link:	revefenacin at DailyMed

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

Constraining patent/regulatory exclusivity:

8,541,451

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 revefenacin

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

Sponsor	Phase
Theravance Biopharma	PHASE4
University of Tennessee Graduate School of Medicine	PHASE4
Mylan Inc.	Phase 4

See all revefenacin clinical trials

Generic filers with tentative approvals for REVEFENACIN

Applicant	Application No.	Strength	Dosage Form
		175MCG/3ML	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for revefenacin

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for revefenacin

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for REVEFENACIN

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 revefenacin

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	7,288,657			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	7,550,595		Y
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	11,008,289
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	10,550,081			Y

Expired US Patents for revefenacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	10,106,503
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	7,910,608
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	7,550,595
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	7,491,736

International Patents for revefenacin

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1930323	Composés biphényle convenant pour la préparation d'antagonistes du récepteur muscarinique (Biphenyl compounds useful in the synthesis of muscarinic receptor antagonists)
Hong Kong	1219415
Singapore	178036	CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND
Poland	2987490
Mexico	2012000682
Israel	216995

Market Dynamics and Financial Trajectory for Revefenacin

Last updated: July 27, 2025

Introduction

Revefenacin is a once-daily nebulized bronchodilator designed for the management of chronic obstructive pulmonary disease (COPD). Developed by Theravance Biopharma and marketed under the brand name Yupelri in the United States, it belongs to the class of long-acting muscarinic antagonists (LAMAs). As with many innovative respiratory treatments, revealing the market potential and financial outlook for revefenacin depends on multiple factors, including clinical positioning, competitive landscape, regulatory approvals, and market penetration strategies.

This detailed analysis dissects the key market dynamics influencing revefenacin’s trajectory, examines its current and projected revenue streams, evaluates competitive pressures, and offers strategic insights pertinent for stakeholders.

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Market Overview and Therapeutic Positioning

COPD remains a leading cause of morbidity and mortality worldwide, with an estimated global prevalence surpassing 200 million cases [1]. The disease imposes substantial economic burdens, including direct healthcare costs and indirect productivity losses. Currently, the standard of care involves bronchodilators—beta-agonists and anticholinergics—often in combination therapies.

Revefenacin distinguishes itself by offering once-daily nebulized delivery, catering to specific patient subsets such as severe cases, elderly populations, or those with difficulty using inhalers. Its approval by the U.S. Food and Drug Administration (FDA) in 2018 marked a strategic attempt to carve out niche segments within the COPD market.

Therapeutic positioning influences its adoption: while inhaler-based LAMAs like tiotropium dominate the space, revefenacin’s nebulized form broadens options for patients with inhalation challenges, potentially expanding market share in specific demographics.

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Current Market Dynamics

Regulatory and Clinical Adoption

Since its approval, revefenacin has received positive clinical reviews emphasizing comparable efficacy to existing inhaled LAMAs with a favorable safety profile [2]. Regulatory approvals in jurisdictions beyond the FDA—such as certain European countries—could catalyze broader adoption, although geographic expansion remains limited as of 2023.

Market Penetration and Prescriber Adoption

Revefenacin's market penetration remains modest compared to inhaler-based LAMAs. Factors such as clinician familiarity, existing formulary preferences, and the entrenched position of established therapies influence adoption rates. Theravance's strategic partnerships with healthcare providers and insurance providers play crucial roles in expanding access and prescribing behavior.

Patient Demographics and Usage Patterns

The nebulized formulation benefits specific populations—such as elderly patients with cognitive or physical impairments—potentially increasing its use among high-need cohorts. Insurance reimbursement policies and cost considerations significantly impact patient access and adherence, thus affecting revenue streams.

Competitive Landscape

Revefenacin operates within a competitive class comprising both branded and generic LAMAs. Major players like Boehringer Ingelheim (tiotropium), GSK (aclidinium), and others dominate the inhaler segment. The niche nebulized market, however, has fewer direct competitors, including drugs like levalbuterol and ipratropium bromide, which do not offer a comparable long-acting profile.

While the segmented nature limits direct competition, it constrains the overall market growth potential. Moreover, emerging inhaler innovations and the advent of dual and triple combinations threaten to erode the incremental advantage of nebulized therapies.

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Financial Trajectory and Revenue Projections

Historical Financials

Since its launch in 2018, revefenacin's regional sales have shown gradual upticks, primarily in the U.S., driven by increased prescribing in specialized pulmonology clinics. Exact revenue figures are proprietary; however, industry estimates suggest annual sales in the low hundreds of millions of dollars [3].

Forecasting Future Revenue

Given the current market scope, the financial trajectory depends on several factors:

• Market Penetration Growth: Assuming targeted expansion among elderly and difficult-to-inhale COPD patients, annual sales could amplify at compound annual growth rates (CAGRs) of 5-10%, contingent on effective market expansion strategies.

• Geographical Expansion: Securing approvals outside the U.S., especially in Europe and Asia, could unlock additional revenue streams. A conservative estimate projects a 20-30% CAGR in these regions over the next five years once approvals are secured.

• Pricing Strategies and Reimbursement: As a specialty drug, revefenacin’s pricing remains premium, with cost-effectiveness discussions ongoing. Reimbursement frameworks significantly influence net sales; favorable policies would boost revenue prospects.

• Pipeline and Formulation Innovations: Future formulations or combination therapies incorporating revefenacin could increase market attractiveness and subsequently, revenue.

Potential Market Cap and Investor Outlook

If revenue grows into the high hundreds of millions or surpasses a billion dollars in targeted regions, revefenacin could become a lucrative asset for Theravance Biopharma, attracting licensing deals or co-marketing arrangements. However, its niche positioning implies limited upside compared to blockbuster inhalers.

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Factors Influencing Future Growth

• Regulatory Approvals and Market Access: Accelerated approvals and favorable reimbursement decisions will be pivotal in scaling revenues.
• Clinical Evidence and Positioning: Demonstrating superior safety, efficacy, or patient adherence benefits over inhaler-based alternatives can expand its use.
• Market Trends: Increasing COPD prevalence, demographic shifts towards older populations, and the unmet needs of inhalation-impaired patients could favor revefenacin’s adoption.
• Competitive and Technological Developments: Innovations, such as combination inhalers or novel delivery systems, could reduce the product’s market share if they outperform nebulized formulations.

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Conclusion and Strategic Outlook

Revefenacin’s current market dynamics reflect a specialized, niche therapeutic role amidst a competitive COPD landscape. Its financial trajectory hinges on strategic expansion, regulatory approvals, and its ability to demonstrate clinical advantages in underserved patient populations.

The drug's incremental growth prospects are promising within its niche, but widespread adoption remains constrained by entrenched inhaler therapies and evolving technological alternatives. Stakeholders should prioritize market access strategies, geographical expansion, and clinical differentiation to maximize revenue streams.

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Key Takeaways

• Niche Positioning: Revefenacin serves a specialized segment of COPD patients who benefit from nebulized therapy, creating a unique market niche with limited direct competition.
• Market Growth Drivers: Increased prevalence of COPD, aging populations, and demand among inhalation-challenged patients will underpin growth opportunities.
• Revenue Potential: Conservative estimates suggest modest revenue growth, with potential to scale if geographic and formulary access expand.
• Competitive Challenges: Dominance of inhaler-based LAMAs and emerging alternatives challenge revefenacin’s market penetration.
• Strategic Focus: To enhance its financial trajectory, revefenacin requires focus on clinical differentiation, expansion into new markets, and favorable reimbursement pathways.

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FAQs

1. What are the primary advantages of revefenacin over traditional inhaled LAMAs?
Revefenacin offers once-daily nebulized delivery, which benefits patients with difficulty using inhalers, such as the elderly or those with cognitive impairments, potentially improving adherence and clinical outcomes.

2. How does the regulatory landscape impact revefenacin’s market growth?
Regulatory approvals in additional regions facilitate broader access and boost sales. Conversely, delays or denials restrict growth and limit revenue expansion.

3. What are the main barriers to revefenacin’s widespread adoption?
Barriers include clinician familiarity with inhaler therapies, reimbursement limitations, and competition from established inhaled LAMAs. Its niche positioning inherently limits it to specific patient subsets.

4. Could combination therapies threaten revefenacin’s market share?
Yes. The development of combination inhalers that simplify COPD management and enhance adherence could diminish the appeal of nebulized monotherapies over time.

5. What strategic actions can Theravance Biopharma pursue to maximize revefenacin’s financial potential?
Strategies include expanding geographical approvals, conducting head-to-head clinical studies demonstrating superiority or safety benefits, engaging with payers for favorable reimbursement, and exploring combination formulations to enhance value propositions.

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Sources
[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD, 2022.
[2] Theravance Biopharma. Revefenacin (Yupelri) prescribing information, 2018.
[3] Industry estimates and market intelligence reports, 2023.