INCRUSE ELLIPTA Drug Patent Profile

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

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

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	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
Japan	5107918
China	1976701	Muscarinic acetylcholine receptor antagonists
Czech Republic	9601807

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	C 2014 041	Romania		PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428
1740177	1490060-9	Sweden		MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
1740177	C01740177/03	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014

Market Dynamics and Financial Trajectory of INCRUSE ELLIPTA

Last updated: December 29, 2025

Executive Summary

INCRUSE ELLIPTA (Umeclidinium bromide), developed by GlaxoSmithKline (GSK), is a once-daily inhaler used for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). Since its FDA approval in 2016, it has positioned itself as a key player within the LAMA (long-acting muscarinic antagonist) segment, competing with predecessors like tiotropium and newer combinations involving LABAs (long-acting β2-agonists) and ICS (inhaled corticosteroids). This comprehensive analysis examines the current market landscape, sales trends, competitive positioning, regulatory influences, and future growth prospects.

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Market Overview

COPD and Inhalation Therapy Market Size

The global COPD treatment market, valued at approximately USD 13.5 billion in 2022, is projected to grow at a CAGR of about 4% through 2030, driven by aging populations and increasing prevalence of tobacco use globally.[1] Inhalation therapies constitute roughly 75-80% of COPD management strategies, split primarily among LAMAs, LABAs, combination inhalers, and corticosteroids.

INCRUSE ELLIPTA's Positioning

As a LAMA monotherapy, INCRUSE captures a notable share within the pure LAMA segment, competing with:

Product	Launch Year	Administration	Market Share (2022)	Key Competitors
INCRUSE ELLIPTA	2016	Once daily	~15-20%	Spiriva (tiotropium), Seebri (glycopyrrolate)
Spiriva	2002	Once daily	~30-35%	-
Seebri Breezhaler	2017	Once daily	~10-15%	-
Ultibro Breezhaler	2013 (EU)	Once daily	N/A (Limited US)	-

Note: Market share figures are approximations sourced from IQVIA (2022 data)

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Market Dynamics Influencing INCRUSE's Financial Trajectory

1. Market Adoption Rates and Prescribing Trends

• Physician Acceptance: GSK’s pulmonary portfolio benefits from strong promotional efforts and a relatively favorable safety profile, fostering prescribing confidence.
• Patient Preference: Once-daily dosing improves adherence, especially critical in chronic diseases like COPD where compliance directly impacts outcomes.
• Guideline Incorporation: GOLD 2023 (Global Initiative for Chronic Obstructive Lung Disease) guidelines recommend LAMAs as first-line maintenance therapy, bolstering INCRUSE's utilization.[2]

2. Competitive Landscape and Product Lifecycle

• Product Differentiation: INCRUSE’s efficacy profile is comparable to Spiriva but lacks the combination therapy options available with newer inhalers integrating LABAs or ICS, such as Trelegy Ellipta.
• Patent Scaffold: Umeclidinium bromide's patents last until 2030 in key markets (US, EU), guiding future exclusivity and generics entry planning.
• Generic Competition: Patents expiry may induce generic competition, potentially reducing revenue by up to 40% over a 3-5 year horizon post-patent expiry.

3. Regulatory & Reimbursement Ecosystem

• FDA & EMA Approvals: Secure approvals facilitate market access.
• Reimbursement Policies: Favorable reimbursement in the US (Medicare/Medicaid), Europe, and Japan support higher adoption rates.
• Pricing Strategies: GSK employs value-based pricing aligned with efficacy and safety profiles, maintaining premium positioning.

4. External Factors Impacting Revenue

Factors	Impact	Mitigation Strategies
COVID-19 pandemic	Negative	Accelerated telehealth, digital marketing
Aging Population	Positive	Increased COPD prevalence
Patent Expiries	Negative	Pipeline diversification
Concomitant Therapy Trends	Neutral	Development of combination therapies

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Financial Trajectory and Sales Forecast

Historical Sales Data

Year	Global Revenue (USD millions)	YoY Growth	Notes
2016	150	N/A	Launch Year
2018	380	+33%	Increasing adoption, expanded markets
2020	420	+10.5%	Market saturation, COVID impact
2022	480	+14.3%	Recovery and expanded indications

Source: IQVIA IMS, GSK annual reports

Projected Sales Outlook (2023-2030)

Year	Expected Revenue (USD millions)	Key Drivers
2023	510	Steady market growth, competitive positioning
2025	620	Patents intact, expanding prescriber base
2027	700	Growth in emerging markets, product diversification
2030	750	Patent expiry, potential generic entry, new formulations

CAGR (2023-2030): ~4.5%

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Comparison with Competitors and Alternative Therapies

Parameter	INCRUSE ELLIPTA	Spiriva	Trelegy Ellipta	Seebri Breezhaler
Formulation	Umeclidinium inhaler	Tiotropium	Fluticasone + Vilanterol + Umeclidinium	Glycopyrrolate inhaler
Dosing Frequency	Once daily	Once daily	Once daily	Once daily
Market Share (2022)	~15-20%	30-35%	Growing	10-15%
Patent Status	Valid until 2030 (US/EU)	Expired	Pending (generic entry)	Active
Combination Therapy	Monotherapy	Monotherapy	Triple inhaler	Monotherapy

Additional points: Combination therapies incorporating LABA and ICS threaten the market share of single agents like INCRUSE, especially as physicians favor personalized, multi-drug formulations.

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Regulatory and Policy Environment

• Global Guidelines: GOLD recommends LAMAs as first-line for moderate to severe COPD, with stepwise advancement.
• Reimbursement Policies: Vary across regions, with high coverage in North America and Europe favoring sustained sales.
• Patent Laws: The expiry dates influence generic entry and price erosion strategies.

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Future Growth Opportunities

Pipeline and Formulation Innovations

• Development of fixed-dose combinations (FDCs) with LABAs (e.g., glycopyrrolate/formoterol)
• Long-acting therapies with improved delivery efficacy to enhance adherence
• Digital inhaler technology integration for remote monitoring

Emerging Market Potential

• Asia-Pacific, Latin America, and Africa present untapped growth channels driven by rising COPD prevalence and increasing healthcare infrastructure investment.
• Estimated annual growth rates in these regions exceed 6%, aiding revenue expansion.

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Key Challenges

• Patent expiration risks.
• Competition from established products and upcoming generics.
• Rapid evolution of combination therapies.
• Regulatory hurdles for new formulations.

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Key Takeaways

• Market Position: INCRUSE ELLIPTA maintains a solid foothold in the COPD monotherapy segment but faces emerging competition from combination therapies.
• Revenue Trajectory: Maintains moderate growth (~4-5% CAGR) until 2030, supported by market expansion, especially in emerging countries.
• Patent Strategy: Patent protection until 2030 offers a window for revenue sustenance; planning for post-patent market share decline is essential.
• Growth Catalysts: Pipeline development, integration of digital health, and regional expansion are critical to sustaining momentum.
• Competitive Edge: Safety profile, dosing convenience, and strong brand presence at GSK facilitate ongoing utilization but must be complemented with innovation.

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FAQs

Q1: How does INCRUSE ELLIPTA compare with other LAMAs in efficacy?
INCRUSE demonstrates comparable efficacy to Spiriva, with similar improvements in lung function and symptom control. Direct head-to-head studies indicate non-inferior outcomes, with differences primarily in dosing convenience and formulation preferences.

Q2: What are the key patent expiration milestones for INCRUSE?
Patent protection in the US and EU is expected to last until 2030, after which generic competition may significantly impact sales unless new formulations or combinations are introduced.

Q3: Is INCRUSE likely to be replaced by combination inhalers?
While combination inhalers that include LABAs and ICS are increasingly preferred due to improved adherence and efficacy, monotherapies like INCRUSE still hold relevance, particularly in early-stage COPD.

Q4: What regions are expected to be the fastest-growing markets for INCRUSE?
Emerging markets, notably China, India, Brazil, and Southeast Asia, are projected to experience higher CAGR (>6%) due to rising COPD prevalence and improving healthcare access.

Q5: How might regulatory changes influence INCRUSE's future?
Stricter approval pathways for generic formulations and increased focus on digital health integration could either challenge or enhance INCRUSE’s market presence, depending on GSK's strategic response.

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References

1. IQVIA. (2022). Global COPD Market Report.
2. GOLD (2023). Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of COPD.

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This comprehensive review underscores INCRUSE ELLIPTA's steady market position, anticipated growth trajectory, and strategic considerations vital for stakeholders aiming to optimize investment and development pathways within the COPD therapeutic landscape.