incruse ellipta Drug Patent Profile

Which patents cover Incruse Ellipta, and what generic alternatives are available?

Incruse Ellipta is a drug marketed by Glaxo Grp England and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-two patent family members in thirty-six countries.

The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Incruse Ellipta

Incruse Ellipta was eligible for patent challenges on December 18, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 18, 2027. This may change due to patent challenges or generic licensing.

There have been six 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.

Indicators of Generic Entry

Summary for incruse ellipta

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Drug Prices:	Drug price information for incruse ellipta
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for incruse ellipta
What excipients (inactive ingredients) are in incruse ellipta?	incruse ellipta excipients list
DailyMed Link:	incruse ellipta at DailyMed

See drug prices for incruse ellipta

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

Constraining patent/regulatory exclusivity:

7,488,827

NDA:

205382

Dosage:

POWDER;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.

Pharmacology for incruse ellipta

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

US Patents and Regulatory Information for incruse ellipta

incruse ellipta is protected by four US patents.

This potential generic entry date is based on patent 7,488,827.

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
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	8,183,257
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	7,498,440		Y	Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	8,309,572
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	7,488,827		Y	Y

Expired US Patents for incruse ellipta

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	5,873,360
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	8,309,572
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	8,183,257
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	7,498,440

EU/EMA Drug Approvals for incruse ellipta

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Incruse Ellipta (previously Incruse)	umeclidinium bromide	EMEA/H/C/002809Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,	Authorised	no	no	no	2014-04-28

International Patents for incruse ellipta

See the table below for patents covering incruse ellipta around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	92565
Taiwan	197380
European Patent Office	1740177	ANTAGONISTES DES RECEPTEURS MUSCARINIQUES DE L'ACETYLCHOLINE (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
Spain	2704042

Supplementary Protection Certificates for incruse ellipta

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
1740177	300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1740177	SPC/GB14/055	United Kingdom		PRODUCT NAME: UMECLIDINIUM BROMIDE (ALSO REFERRED TO AS 4-(HYDROXY(DIPHENYL)METHYL)-1-(2-((PHENYLMETHYL)OXY)ETHYL)-1-AZONIABICYCLO(2.2.2)OCTANE BROMIDE); REGISTERED: UK EU/1/14/922/001 20140430; UK EU/1/14/922/002 20140430; UK EU/1/14/922/003 20140430

Market Dynamics and Financial Trajectory for INCRUSE ELLIPTA

Last updated: July 27, 2025

Introduction

INCRUSE ELLIPTA (umeclidinium bromide inhalation powder) stands as a significant therapeutic agent in the management of chronic obstructive pulmonary disease (COPD). Approved by the U.S. Food and Drug Administration (FDA) in 2016, it functions as a long-acting muscarinic antagonist (LAMA). Its market landscape is shaped by evolving COPD treatment paradigms, competitive dynamics, regulatory trends, and advancing pharmaceutical commercialization strategies. This analysis delineates the current market environment and forecasts the financial trajectory of INCRUSE ELLIPTA over the forthcoming years.

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Market Landscape and Demand Drivers

Global COPD Burden and Market Opportunities

COPD affects over 200 million individuals globally, with a significant prevalence in North America, Europe, and parts of Asia. The disease's progressive nature necessitates long-term management, creating sustained demand for maintenance inhalers like INCRUSE ELLIPTA. The global COPD drugs market was valued at approximately USD 13.5 billion in 2022 and is projected to grow at a CAGR of 4.7% through 2030, driven by increased awareness and aging populations (source: Grand View Research).

Therapeutic Positioning of INCRUSE ELLIPTA

INCRUSE ELLIPTA is positioned as a once-daily LAMA monotherapy for COPD maintenance, often used in combination with inhaled corticosteroids (ICS) or long-acting beta2-agonists (LABA). Its ease of use, favorable safety profile, and efficacy have established it as a preferred choice among clinicians, particularly in mild-to-moderate COPD cases.

Competitive Landscape

Key competitors include tiotropium (SPIRIVA), glycopyrronium (INCRUSE/Ellipta), aclidinium (BRONCHITOL), and combination products such as Trelegy Ellipta. The competitive edge of INCRUSE ELLIPTA hinges on its once-daily dosing, inhaler device design, and clinical efficacy demonstrated in pivotal trials like the ELLIPTA studies.

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Regulatory and Reimbursement Environment

Regulatory Approvals and Extensions

Since its initial approval, INCRUSE ELLIPTA has gained additional indications and received regulatory designations enhancing its market access. Notably, approvals in multiple jurisdictions—European Union, Japan, and emerging markets—bolster its global footprint.

Reimbursement Dynamics

Strong reimbursement policies, especially in North America and Europe, underpin consistent prescription uptake. However, price competition and drug formulary negotiations could influence market share trajectories, requiring strategic engagement with payers.

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Market Dynamics Influencing Financial Trajectory

Pricing Strategies and Market Penetration

In the highly competitive COPD segment, price sensitivity remains pivotal. INCRUSE ELLIPTA has employed value-based pricing within regulatory constraints, optimized through patient adherence programs and real-world evidence demonstrating cost-effectiveness.

Prescription Trends and Adoption Rates

The adoption rate is impacted by prescriber familiarity, switching patterns from other LAMAs, and clinical preferences for combination therapies. Since 2020, increased awareness from clinical guidelines incorporating dual and triple therapy options has diversified treatment pathways, potentially diluting monotherapy sales but expanding overall COPD management markets.

Clinical Guidelines and Treatment Paradigms

Guideline updates, notably GOLD 2023, emphasize personalized therapy, integrating inhaler device considerations. INCRUSE ELLIPTA’s once-daily dosing aligns well with these directives, fostering acquisition and retention.

Patent and Exclusivity Expiry

Patent exclusivity for INCRUSE ELLIPTA extends into the late 2020s, providing a period of market monolith. Future generic or biosimilar entrants could exert downward pressure on pricing and market share post-expiry.

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Financial Forecasts and Growth Projections

Based on current market trends, clinical adoption trajectories, and competitive positioning, the financial outlook for INCRUSE ELLIPTA appears positive, with specific nuances:

Sales Growth Projections

• 2023-2025: An annual growth rate approximating 6-8%, driven by increased penetration in both developed and emerging markets.
• 2025-2030: Growth moderates to 4-6%, reflecting market maturity, generic threats, and saturation in key regions.

Market Share and Revenue Outlook

Assuming continued uptake in established markets, INCRUSE ELLIPTA could secure a 15-20% share of the global COPD inhaler market by 2030. Revenue estimates project doubling from approximately USD 1.2 billion in 2022 to USD 2.4-2.6 billion in 2030, contingent upon market expansion and pricing strategies.

Impact of Portfolio Synergies

The product's integration into broader inhaler portfolio strategies—such as combination therapies and pipeline expansion—may augment revenue streams. Collaboration efforts with health systems and payers will influence the net profitability.

Emerging Markets and Developmental Pipeline

Expanding into Asia-Pacific and Latin America offers significant upside, provided regulatory approvals and distribution logistics align. R&D investments into fixed-dose combination products and novel delivery devices could augment long-term financial performance.

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Strategic Considerations and Risks

Competitive Innovation

Disruptive inhaler technologies (e.g., smart inhalers) and next-generation bronchodilators pose ongoing threats, making continuous innovation vital.

Regulatory Changes

Evolving regulatory standards and pricing reforms, especially in the EU and US, could impact revenue margins.

Patent Litigation and Generics

The expiry of patent protections may lead to generic competition, reducing sales unless strategies such as formulation patents or market exclusivity extensions are employed.

Market Penetration in Emerging Economies

Barriers include pricing, patent litigation, and infrastructure challenges; careful local market assessments are essential.

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Conclusion

INCRUSE ELLIPTA's market position remains robust amid a dynamic COPD pharmaceutical landscape. Its long-term financial trajectory hinges on sustained clinical adoption, strategic pricing, regulatory navigation, and innovation. While near-term growth prospects are promising, market maturity and potential generics underscore the necessity for continual adaptation.

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Key Takeaways

• INCRUSE ELLIPTA maintains a strong position in the COPD maintenance therapy market, with projected revenue growth of approximately 6-8% annually through 2025.
• Market drivers include rising COPD prevalence, clinician preference for once-daily inhalers, and positive clinical trial data.
• Competitive pressures from generics and emerging therapies necessitate strategic innovation and comprehensive market access policies.
• Expansion into emerging markets offers substantial growth opportunities, contingent on effective regulatory and distribution strategies.
• Long-term success depends on lifecycle management, including pipeline development, formulation patents, and leveraging digital health trends.

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FAQs

1. How does INCRUSE ELLIPTA compare to other LAMAs in efficacy?
Clinical trials demonstrate that INCRUSE ELLIPTA offers comparable efficacy to other LAMAs such as tiotropium, with benefits in patient adherence due to its once-daily dosing and inhaler design.

2. What are the primary factors influencing INCRUSE ELLIPTA’s market share?
Market share is driven by prescriber preference, formulary coverage, competitive pricing, patient adherence, and the availability of combination therapies.

3. What risks could limit the growth of INCRUSE ELLIPTA?
Patent expiration, influx of generic competitors, regulatory changes, and the advent of superior inhaler technology or combination drugs pose significant risks.

4. Are there ongoing pipeline developments related to INCRUSE ELLIPTA?
Yes, ongoing research focuses on fixed-dose combination formulations, improved delivery devices, and novel muscarinic antagonists to expand therapeutic options.

5. How could COVID-19 have impacted INCRUSE ELLIPTA’s market?
The pandemic interrupted routine healthcare access and prescription patterns, but increased focus on respiratory health and telemedicine may offset some disruptions over the long term.

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Sources:

1. Grand View Research. COPD Drugs Market Size & Share Analysis. 2022.
2. FDA Drug Approvals. INCRUSE ELLIPTA approval documentation, 2016.
3. GOLD Reports. Global Initiative for Chronic Obstructive Lung Disease, 2023.