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

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
University of Tennessee Graduate School of Medicine	PHASE4
Theravance Biopharma	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			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes				Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes

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
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018

International Patents for revefenacin

Country	Patent Number	Title	Estimated Expiration
Slovenia	1723114
South Korea	101742252
New Zealand	549472	Biphenyl compounds useful as muscarinic receptor antagonists
Singapore	10201407913U	CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND

Market Dynamics and Financial Trajectory for REVEFENACIN

Last updated: December 14, 2025

Executive Summary

Revefenacin, marketed as Yupelri, is a long-acting muscarinic antagonist (LAMA) approved by the FDA in 2018 for the treatment of chronic obstructive pulmonary disease (COPD). Its market positioning, competitive landscape, and financial trajectory are shaped by evolving COPD management protocols, regulatory considerations, patent landscape, and emerging therapies.

This article provides an exhaustive analysis of Revefenacin's market dynamics, growth drivers, competitive environment, and financial prospects, offering a comprehensive outlook to stakeholders.

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What is Revefenacin and How Does It Fit into COPD Treatment?

Aspect	Details
Drug Class	Long-acting muscarinic antagonist (LAMA)
Brand Name	Yupelri (U.S.)
Indications	Maintenance treatment of COPD
Approval Date	October 2018 (FDA)
Administration	Inhalation via nebulizer
Unique Feature	First once-daily nebulized LAMA for COPD

Revefenacin addresses unmet needs in COPD management, particularly for patients requiring nebulized therapy due to difficulty with inhaler use, typically in elderly or severe cases.

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Market Landscape: Overview and Size

Global COPD Market Overview

• Market Size (2022): ~$13.6 billion (Grand View Research)
• Projected CAGR (2022-2030): 4.9%
• Key players: GlaxoSmithKline (GSK), AstraZeneca, Boehringer Ingelheim, Novartis, Mylan (now Viatris), and Teva.

Revefenacin’s Positioning in the COPD Market

Parameter	Details
Market Penetration (2022)	Estimated at 7-10% among nebulized COPD therapies
Major Regions	North America (~65%), Europe (~25%), Rest of World (~10%)
Pricing (U.S.)	Approx. $500 per inhalation (varies by payer and setting)
Distribution Channels	Specialty pharmacies, hospital formularies, retail pharmacies

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Market Drivers for Revefenacin

Driver	Impact	Evidence/Source
Aging Population	Increased COPD prevalence	WHO estimates 200 million+ affected globally [1]
Nebulized Therapy Demand	Especially among elderly with inhaler technique issues	FDA reports, clinical trial enrollment data
Regulatory Environment	Favorable approval pathway for novel nebulized formulations	FDA's recognition of unmet needs (2018+)
Product Differentiation	Once-daily, nebulized LAMA	Clinical superiority in specific patient groups

Market Restraints and Challenges

Restraint	Impact	Evidence/Source
Generic Competition	Limited initially, but patent expiry looming	Patent data, volume of generics filings
Generic Competition After Patent Expiration	Price erosion, reduced margins	Historical case studies (e.g., Tiotropium)
Limited Awareness in Clinical Practice	Slower adoption	Surveys from pulmonology societies (e.g., ACCP)
Pricing Pressures	Payer negotiations and formulary restrictions	CMS and private insurer policies

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Financial Trajectory Analysis

Revenue Projections (2023-2030)

Year	Estimated Revenue (USD billions)	Assumptions
2023	$0.07 to $0.10	Early market penetration, growing awareness
2025	$0.15 to $0.22	Increased adoption, expanded geographic reach
2027	$0.3 to $0.4	Broader clinical acceptance, formulary inclusion
2030	$0.5 to $0.8	Maturation, potential new indications

Assumptions:

• CAGR of approximately 25-30% pre-patent expiry, slowing thereafter.
• Entry into additional markets (EU, Asia).
• Potential pipeline expansions or new formulations.

Cost Structure and Profitability

Cost Component	Estimated Percentage	Notes
Manufacturing	15-20%	Reduction over time with scale
R&D	5-10%	Ongoing, for pipeline or formulation improvements
Marketing & Sales	20-25%	Launch, physician education, patient awareness
Regulatory & Legal	5%	Patent litigations, approvals

Profit margins initially narrow (~10-15%) but could improve with scale and patent protection.

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Patent and Regulatory Landscape

Patent Lifecycle

Patent Type	Validity	Expiry Date	Notes
Composition of Matter	10-12 years from approval	Around 2030	May be extended via patentsยา
Method of Use	Additional 5-8 years	Up to 2035	Patent extensions possible

Implication: Patent expiry in the early to mid-2030s opens the market to generics or biosimilars, pressuring prices and margins.

Regulatory Policies

• FDA: Approved via novel NDA pathway, with further requirements for post-market surveillance.
• EMA: Approved under decentralised procedures; similar approval for broader European access.
• Pricing & Reimbursement: Payer negotiations pivotal; inclusion in formularies critical for growth.

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Competitive Environment

Competitor	Drug Name	Class	Market Share (2022)	Key Advantages	Limitations
GSK	Spiriva (Tiotropium)	LAMA	40%	Established, twice-daily, broad indication	Inhaler device complexity
AstraZeneca	Symbicort	ICS/LAMA	25%	Dual therapy, extensive data	Not nebulized
Boehringer Ingelheim	Spiriva Respimat	LAMA	10%	Ease of use	Limited in nebulized segment
Teva	ASD-510	LAMA	5%	Focused nebulized delivery	Market penetration ongoing
Revefenacin	Yupelri	LAMA	7-10%	Once-daily nebulized	New entrant, limited awareness

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Emerging Trends and Future Opportunities

Pipeline and Adjacent Indications

• Potential for combinatorial therapies (e.g., with LABAs or ICS)
• Expanding indications: Asthma, bronchiectasis
• Delivery innovations: Miniaturized nebulizers, smart inhalers

Market Access and Policy Impact

• Reimbursement models favor value-based care
• Politicization of drug pricing could influence margins
• Global expansion in emerging markets (e.g., Asia-Pacific) driven by COPD burden

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Comparison of Key Global Markets

Region	COPD Prevalence (millions)	Reimbursed Market Share	Regulatory Status	Market Growth Rate
North America	16	~70%	Mature, approvals complete	4.5-5% CAGR
Europe	16	~60%	Mature, strong reimbursement	3-4% CAGR
Asia-Pacific	>60	Growing, diverse policies	Approvals ongoing in some countries	6-7% CAGR
Latin America	~10	Limited	Emerging	4-5% CAGR

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Key Market Entry and Growth Strategies

• Partner with payers to include Revefenacin in formulary plans
• Invest in pulmonology-focused marketing to increase prescriber awareness
• Expand geographical presence through strategic alliances and licensing
• Innovate through combination formulations to enhance efficacy and adherence
• Monitor patent expiry schedules to navigate generic entry and sustain revenue

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Concluding Remarks

Revefenacin stands at a pivotal point in its market lifecycle. Its unique nebulized once-daily administration positions it favorably within the niche of severe COPD patients, yet its growth trajectory depends heavily on regional adoption, pricing strategies, and patent protection. The impending patent expiry in the early 2030s will be a critical inflection point, necessitating proactive lifecycle management, pipeline innovation, and strategic market expansion.

Key Takeaways

• Market Potential: Growing COPD prevalence coupled with a niche for nebulized therapies offers substantial upside.
• Revenue Drivers: Adoption in North America and Europe, payer inclusion, and further pipeline expansion.
• Challenges: Patent expiries, generic competition, and clinical adoption barriers.
• Strategic Focus: Building strong payer relationships, international expansion, and innovation.
• Long-Term Outlook: Sustained growth predicated on effective lifecycle management and pipeline development.

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FAQs

1. When is the patent expiration for Revefenacin, and how will it impact the market?
Patent protection is expected to last until approximately 2030–2033, depending on patent extensions. Expiry will likely introduce generics, leading to price erosion and increased competition.

2. How does Revefenacin compare to other COPD therapies regarding efficacy and safety?
Clinical trials demonstrate non-inferiority to other LAMAs, with comparable safety profiles. Its once-daily nebulized delivery uniquely benefits patients with inhaler technique difficulties.

3. What are the main barriers to wider adoption of Revefenacin in clinical practice?
Limited clinician awareness, high cost relative to some inhalers, and existing entrenched competitor products pose barriers. Demonstrating clear clinical advantages is key.

4. What are the opportunities for pipeline development around Revefenacin?
Potential exists for fixed-dose combinations, new delivery systems, and expanding indications like asthma or bronchiectasis, which could prolong product lifecycle.

5. How can pharmaceutical companies mitigate revenue decline post-patent expiry?
Developing follow-on formulations, expanding into new markets, investing in lifecycle extensions, and innovative combination therapies are strategic options.

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References

[1] World Health Organization. “Chronic obstructive pulmonary disease (COPD).” WHO, 2022.