YUPELRI Drug Patent Profile

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

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-four 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:	74
US Patents:	10
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

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

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
Hungary	E026414
South Korea	20070011370	BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS
Japan	2016026214	ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND)
European Patent Office	2987490
European Patent Office	2453894
Canada	2989129	FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND)

YUPELRI (revefenacin): Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

Where does YUPELRI sit in the COPD inhaled competitive landscape?

YUPELRI (revefenacin) is an inhaled long-acting muscarinic antagonist (LAMA) for maintenance treatment of COPD. Commercial positioning is driven by once-daily dosing, nebulized delivery, and the switch to resident LAMA therapy in chronic symptom control. The competitive set is led by inhaled LAMA/LABA and LAMA products across dry powder inhalers (DPIs) and metered dose inhalers (MDIs), with nebulized LAMA alternatives also relevant for patients who cannot use hand-held inhalers.

Key market dynamics shaping demand

• Patient-device fit drives share: Nebulized LAMA therapy keeps relevance for patients with poor inhaler technique, cognitive or physical limitations, or intolerance to DPI/MDI workflows.
• Therapy choice depends on symptoms and exacerbation history: COPD maintenance prescribing patterns increasingly favor fixed-dose combinations for higher-risk patients, but monotherapy persists for stable disease or when combination escalation is not indicated.
• Formulary pressure is persistent: Payers increasingly use step edits, prior authorization, and formulary tiering to manage inhaled respiratory budgets.
• Seasonality and adherence matter: Respiratory maintenance products track chronic adherence cycles; churn and refill timing can move quarterly sales even without major label changes.

How is YUPELRI’s financial trajectory trending?

YUPELRI is marketed by Teva Pharmaceuticals USA in the United States. Public financial disclosure for prescription revenue by specific product can be limited depending on reporting granularity, but multiple inflection points shape trajectory: launch scale-up, competitive penetration, and subsequent payer and channel shifts.

Observed sales direction (high-level)

• Post-launch growth phase: YUPELRI scaled in the initial years after commercialization as nebulized LAMA adoption expanded and prescribers built experience with nebulized maintenance therapy.
• Ongoing competitive pressure: As dual therapy (LAMA/LABA) and triple therapy (LAMA/LABA/ICS) gained share for higher-risk COPD patients, LAMA monotherapy faced share compression outside the nebulized-appropriate patient segment.
• Quarterly volatility is channel-driven: Pneumology clinics, long-term care, and pharmacy benefit management dynamics can cause lumpy net unit movement even when underlying patient demand is stable.

What are the product’s commercial drivers and constraints?

Drivers

• Once-daily nebulization for maintenance COPD: The dosing profile is designed to reduce daily treatment burden and support adherence.
• Clinical differentiation as a LAMA: Revefenacin’s mechanism aligns with guideline-based maintenance therapy.
• Expanded use among nebulizer users: Patients who require or prefer nebulized therapy are a structural demand pool for YUPELRI.

Constraints

• Substitution risk from combination inhalers: LAMA/LABA products can displace monotherapy when payers and prescribers target symptom and exacerbation reduction.
• Price and access pressure: Like other branded respiratory drugs, YUPELRI faces ongoing rebate and formulary negotiations that can compress net revenue per unit.
• Generic and class-level competition: Even if YUPELRI maintains exclusivity for itself, class-level substitution and competitive brand intensity influence total market opportunity.

What does the patent and exclusivity timeline imply for long-term revenue risk?

YUPELRI is protected by composition-of-matter and method patents plus regulatory exclusivities in the US. The long-term revenue curve depends on:

• Staying within the protected label scope (avoiding carve-outs that enable earlier competition).
• Defending formulation, crystal form, or dosing regimen IP (when applicable).
• Regulatory and patent challenges that can shorten exclusivity or delay at-launch competition.

Exclusivity anchor points (US)

• NDA/approval and regulatory exclusivity matter for entry timing for any future generics or “authorized” competitors.
• Patent life extends beyond initial marketing: The remaining term drives the risk window for full generic entry.

(Refer to the US patent and exclusivity record for revealed Orange Book-listed patents and expiry dates.)

What could change YUPELRI’s trajectory in the next 12 to 24 months?

Demand-side changes

• Formulary outcomes: If YUPELRI gains preferred positioning for nebulizer-eligible patients, prescription share can improve even within a mature COPD market.
• Prescriber channel shift: Increased use in community pulmonology and integrated delivery networks can lengthen the sales runway.
• Adherence improvements: Better refill persistence can lift prescription-to-patient conversion and reduce churn in chronic maintenance populations.

Supply and distribution

• Inventory normalization and specialty distribution performance influence quarterly shipments and net sales timing.
• Contract renegotiations with wholesalers and PBMs affect net price and effective revenue.

Competitive responses

• Combination therapy marketing: LAMA/LABA and triple-therapy brands can target the same COPD patient segments, reducing monotherapy addressable demand.
• Nebulized competitive set: Any new nebulized LAMA/LABA entrant or intensified promotion by incumbents can pressure net units.

Market sizing context: where the revenue headroom comes from

YUPELRI’s revenue potential depends on how much of the COPD maintenance population:

1. Requires or prefers nebulization,
2. Remains on monotherapy rather than escalating to dual/triple therapy,
3. Stays persistent beyond the first 90-180 days.

Because COPD is chronic, the payer and prescriber environment often determines whether that pool expands or contracts more than clinical adoption alone.

Segment-level implications for payer access and contracting

Coverage mechanisms

• Prior authorization is common for branded inhaled respiratory drugs, often tied to step therapy rules.
• Quantity limits can apply where dosing schedules and nebulizer administration workflows raise utilization costs.
• Specialty pharmacy distribution rules may influence patient initiation speed.

Net revenue sensitivity

YUPELRI net sales move with:

• rebate levels and gross-to-net erosion
• channel mix shifts (specialty vs retail, provider-administered settings where applicable)
• timing of contract renewals

Competitive benchmarking: how YUPELRI compares on commercial levers

Commercial lever comparison

Lever	YUPELRI (revefenacin, nebulized LAMA)	DPI/MDI LAMA/LABA competition
Device channel	Nebulizer-eligible patients	Broader device use, but excludes some patients who cannot use handheld inhalers
Dosing simplicity	Once daily supports adherence	Once/twice daily regimens vary by product
Prescriber pathway	Pulmonology and COPD maintenance management	High-frequency prescribing within mainstream inhaler workflows
Payer navigation	Step edits may be used; monotherapy restrictions can apply	Combination products can win access for higher-risk cohorts
Substitution risk	Class-level and combination escalation	Lower substitution resistance among inhaler-capable patients

What financial signals are most important to track?

For underwriting or investment monitoring, the relevant KPIs for YUPELRI track commercial effectiveness and net realization:

• Prescription volume trends (TRx growth vs decline)
• Gross-to-net changes (rebate and discount movements)
• Net sales growth vs unit growth (pricing vs volume)
• Channel mix (specialty vs retail, prescriber-administered vs patient-administered)
• Formulary status changes by major PBMs and Medicaid managed care where accessible

Key Takeaways

• YUPELRI operates in COPD maintenance as a nebulized once-daily LAMA, with demand concentrated among nebulizer-eligible patients and those maintained on monotherapy.
• The core financial trajectory is shaped by formulary access, PBM contracting, and substitution by LAMA/LABA and triple-therapy regimens for higher-risk patients.
• Long-term revenue risk is linked to US patent and regulatory exclusivity expiries, plus the pace of class and combination competition.
• Near-term movement is most sensitive to net pricing (rebates and access) and channel-level prescription persistence rather than label changes.

FAQs

1) Is YUPELRI a first-line COPD maintenance product or a later-line option?

It is positioned as maintenance therapy for COPD, used in the monotherapy space and within stepwise prescribing decisions that can later escalate to dual or triple therapy for more symptomatic or higher-risk patients.

2) What limits YUPELRI’s growth in a mature COPD market?

The main limits are formulary step edits restricting branded monotherapy and substitution toward LAMA/LABA or triple therapy products for patients who qualify for escalation.

3) Does delivery format materially affect patient selection?

Yes. Nebulized delivery supports a segment of patients who cannot reliably use inhalers, which can stabilize or concentrate YUPELRI demand.

4) How should net sales be evaluated versus unit prescriptions?

Net sales must be evaluated alongside TRx and gross-to-net. Unit stability with net erosion can indicate payer cost pressure even when patient demand remains steady.

5) What is the biggest IP-related financial risk for YUPELRI?

US patent and regulatory exclusivity expiry and the associated risk of generic or competitive entry that can compress revenue post-protection.

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References

[1] FDA. “YUPELRI (revefenacin) prescribing information.” U.S. Food and Drug Administration.
[2] FDA. “Drugs@FDA: YUPELRI (revefenacin).” U.S. Food and Drug Administration.
[3] FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.