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 ten 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 four 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:	10
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YUPELRI

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 ten US patents.

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
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

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
Mexico	2012000682
Portugal	2453894
South Korea	20130027004

Investment Scenario and Fundamentals Analysis of YUPELRI (revefenacin)

Last updated: February 20, 2026

What Is the Market Position and Commercial Outlook for YUPELRI?

YUPELRI (revefenacin) is a nebulized long-acting muscarinic antagonist (LAMA) approved for COPD treatment. It was approved by the U.S. FDA in September 2018. Marketed by Theravance Biopharma and Mylan (now part of Viatris), it targets a niche segment of COPD patients preferring nebulizer therapy.

Market Size and Growth Potential

COPD is a leading cause of morbidity globally, with an estimated 200 million affected worldwide and a U.S. prevalence of about 15 million. The COPD treatment market is projected to reach $10–12 billion by 2027. YUPELRI’s target segment—patients requiring nebulization—is smaller but growing due to increasing aging populations and patients with severe disease.

Revenue Performance and Market Penetration

• In 2022, YUPELRI's U.S. sales were approximately $135 million.
• The drug holds an estimated 10% of the nebulized COPD treatment market.
• Competition from other nebulized drugs is limited; DPI (dry powder inhaler) devices dominate the broader COPD market.

Strategic Position

YUPELRI’s high barrier to competition arises from its specific formulation as a nebulized medication with proven efficacy and safety. Launch efforts focus on elderly, severe COPD patients, who often prefer nebulization due to ease of use.

How Do the Fundamental Data and Clinical Profile Support Investment?

Pharmacology and Clinical Trial Data

• Revefenacin is a selective muscarinic antagonist with a once-daily dosing regimen.
• Phase III trials demonstrated significant improvements in trough FEV1 compared to placebo.
• Safety profile: similar to placebo, with dry mouth and cough being the most common adverse events.

Regulatory and Patent Status

• Approved by the FDA in September 2018.
• Patent protections extend through 2027–2028, with some formulations potentially extending exclusivity.
• No generic versions are available, reducing immediate competitive pressure.

Pipeline and R&D Pipeline

• Theravance targets additional indications, such as asthma and other COPD forms.
• Exploration of combination therapies with beta-agonists is ongoing.
• No major pipeline diversification anticipated within the next 2–3 years.

Financials and Investment Risks

• Revenue generation remains moderate but stable.
• Key risks include pipeline failure, patent expiry, and market share erosion from competitors, including other nebulized agents and new inhaler devices.
• Manufacturing costs are stable, with no recent supply chain disruptions reported.

What Are the Key Drivers and Risks for Investment?

Drivers

• Growing COPD prevalence in aging populations.
• Niche market with less competition.
• Clinical efficacy and favorable safety profile.
• Expanding use in severe COPD cases and elderly patients.

Risks

• Patent expiry in late 2020s could invite generic competition.
• Market share could decline if new inhaler products or combination therapies disrupt the niche.
• Potential regulatory changes affecting nebulized drug formulations.
• COVID-19 pandemic effects, which may reduce in-office nebulizer use temporarily.

How Does YUPELRI Compare to Market Alternatives?

Drug	Formulation	Dosing	Market Share (2022)	Key Advantages	Key Disadvantages
YUPELRI	Nebulized LAMA	Once daily	10% in nebulized COPD	Suitable for elderly, severe cases	Limited to nebulized use
Spiriva (tiotropium)	DPI	Once daily	Leading LAMA	Widely adopted, robust data	Not suitable for all patients
Anoro Ellipta	DPI (combo)	Once daily	Increasing in market	Combines LAMA + LABA	Higher price point

Summary of Investment Fundamentals

• Market Position: Niche but stable segment within COPD market, with growth driven by an aging population and increasing severity.
• Revenue Outlook: Moderate but consistent; potential uptick with expanded indications.
• Patent Security: Till late 2020s; early generic entry risk.
• Pipeline and R&D: Limited near-term pipeline, some exploration in combo therapies.
• Competitive Environment: Low competition within nebulized LAMA space, but vulnerable to inhaler device innovations.

Key Takeaways

• YUPELRI offers a stable revenue stream within a specialized COPD segment.
• Growth prospects depend on aging demographics and acceptance among severe COPD patients.
• Patent expiry plans pose medium-term risks; competitive landscape remains relatively stable currently.
• The drug’s niche positioning and proven efficacy support a cautious optimistic outlook.

FAQs

1. What is the primary indication of YUPELRI?
   COPD management in patients who benefit from nebulization.

2. When will patent expiry impact YUPELRI’s exclusivity?
   Likely between 2027 and 2028, allowing for potential generic competition.

3. Are there any approved combination therapies involving YUPELRI?
   Currently, none are approved; R&D efforts are ongoing.

4. How does market penetration compare to inhaler-based alternatives?
   It remains a smaller segment, with about 10% market share in nebulized COPD treatment.

5. What are the primary risks for investors?
   Patent expiration, market share erosion, patent litigation, and entry of rival therapies.

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References

[1] Expert Market Research. (2022). COPD Treatment Market Report.
[2] U.S. Food and Drug Administration. (2018). FDA approves YUPELRI for COPD.
[3] Theravance Biopharma. (2022). Annual Report.
[4] MarketWatch. (2023). COPD drugs market analysis.
[5] ClinicalTrials.gov. (2023). Revefenacin clinical studies overview.