ANORO ELLIPTA Drug Patent Profile

When do Anoro Ellipta patents expire, and what generic alternatives are available?

Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and fifty-four patent family members in fifty-one countries.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Anoro Ellipta

Anoro Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29, 2030. 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 ANORO ELLIPTA

International Patents:	254
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	49
Patent Applications:	516
Drug Prices:	Drug price information for ANORO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANORO ELLIPTA
What excipients (inactive ingredients) are in ANORO ELLIPTA?	ANORO ELLIPTA excipients list
DailyMed Link:	ANORO ELLIPTA at DailyMed

See drug prices for ANORO ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA

Constraining patent/regulatory exclusivity:

9,750,726

NDA:

203975

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.

Recent Clinical Trials for ANORO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline	PHASE4
University of Tennessee Graduate School of Medicine	PHASE4
Theravance Biopharma	PHASE4

See all ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

US Patents and Regulatory Information for ANORO ELLIPTA

ANORO ELLIPTA is protected by nine US patents.

This potential generic entry date is based on patent 9,750,726.

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
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	12,396,986		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	9,750,726		Y

Expired US Patents for ANORO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	8,183,257
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	5,873,360
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	RE44874

International Patents for ANORO ELLIPTA

When does loss-of-exclusivity occur for ANORO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Ukraine

United Kingdom

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 ANORO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	351290	COMBINACIONES DE UN ANTAGONISTA DE LOS RECEPTORES MUSCARÍNICOS Y UN AGONISTA DEL ADRENO-RECEPTOR BETA-2. (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST.)
European Patent Office	1467789	Distributeur de médicament (Medicament dispenser)
Australia	2021204302	COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2506844	C02506844/01	Switzerland		PRODUCT NAME: UMECLIDIN UND VILANTEROL UND FLUTICASONFUORAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66808 20.09.2018
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117

Market Dynamics and Financial Trajectory for ANORO ELLIPTA

Last updated: July 27, 2025

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Introduction

ANORO ELLIPTA (umeclidinium/vilanterol) is a leading inhaled medication designated for the management of chronic obstructive pulmonary disease (COPD). Developed jointly by asthma and COPD specialists, the drug combines a long-acting muscarinic antagonist with a long-acting β2-agonist, offering a convenient once-daily dosing regimen. Given the rising prevalence of COPD worldwide and innovative pharmacological profiles, analyzing the market dynamics and financial trajectory of ANORO ELLIPTA is critical for stakeholders aiming to understand its commercial outlook and strategic positioning within the respiratory therapeutics landscape.

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Market Overview and Demand Drivers

Growing Global COPD Prevalence

COPD affects over 250 million individuals globally, with the World Health Organization (WHO) estimating it as the third leading cause of death worldwide [1]. Prevalence rates are projected to increase due to rising tobacco use, aging populations, and environmental pollutants. The increasing disease burden sustains a strong demand for inhaled maintenance therapies like ANORO ELLIPTA, which reduces exacerbation risks and improves patient quality of life.

Therapeutic Positioning and Market Penetration

ANORO ELLIPTA’s once-daily dosing offers a significant adherence advantage over multiple daily therapies, contributing to its growing adoption. Its efficacy in reducing exacerbations compared to monotherapies makes it a preferred choice for clinicians. Major markets include the US, European Union, Japan, and emerging economies, where increasing COPD awareness and guidelines favor dual-bronchodilator therapies.

Competitive Landscape

The COPD inhaler market is highly competitive, featuring molecules like tiotropium, glycopyrrolate, and other combination products (e.g., Trelegy Ellipta, Advair). ANORO ELLIPTA's key competitors include:

• Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol): Offers triple therapy in a single inhaler.
• Spiriva Respimat (tiotropium): Leader in long-acting muscarinic antagonist segment.
• Relvar/Breo Ellipta: Combines inhaled corticosteroids with long-acting β2-agonists.

Positioning as a preferred dual-therapy highlights ANORO ELLIPTA’s strengths but necessitates continuous differentiation for market sustenance.

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Market Dynamics Impacting ANORO ELLIPTA

Regulatory Approvals and Reimbursement Environments

Streamlined FDA approvals and favorable reimbursement strategies in major territories bolster ANORO ELLIPTA’s market reach. In the US, inclusion in the CMS formularies and approval from authorities like NICE (UK) facilitate reimbursement, fostering adoption.

Pricing Strategies and Competitive Pricing

Pricing of inhalers significantly influences market share. Pharmacoeconomic evaluations—highlighting reductions in exacerbations and hospitalizations—justify premium pricing. Effective managed care contracts and formulary placements are crucial for revenue growth.

Pipeline and Portfolio Expansion

The success of ANORO ELLIPTA encourages sister formulations and combination therapies. The introduction of triple therapies like Trelegy Ellipta serves as a threat and opportunity, either cannibalizing or complementing ANORO's sales.

Patient Preference and Adherence

Inhaler design improvements, digital inhalers with adherence tracking, and educational interventions enhance long-term patient compliance, directly influencing drug utilization rates.

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Financial Trajectory and Revenue Projections

Revenue Trends and Market Penetration

Based on recent data, ANORO ELLIPTA has experienced steady revenue growth. In the fiscal year 2022, global sales surpassed $1.5 billion, representing a compound annual growth rate (CAGR) of approximately 10% over the past five years [2]. North America remains the dominant market, accounting for roughly 60% of sales, driven by high COPD prevalence and advanced healthcare infrastructure.

Forecasting Future Revenue

Projections indicate consistent growth over the next 5-10 years due to:

• Increasing patient population: Conservatives predict COPD prevalence will rise by 20-25% in emerging economies within the same period.
• Expanded utilization: Broader adoption in primary care and earlier intervention in disease progression.
• Market expansion: Entry into new territories and secondary indications, if any, could further diversify revenue streams.

Analysts estimate that annual global sales could reach $2.5-$3 billion by 2030, contingent on competitive dynamics and regulatory developments.

Risks and Challenges

• Patent expiries: Loss of exclusivity could trigger generic competition, impacting margins.
• Pricing pressures: Cost containment measures and biosimilar entries could constrain pricing strategies.
• Market saturation: In mature markets, incremental growth may plateau without innovation or portfolio diversification.

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Strategic Considerations for Stakeholders

To capitalize on current market dynamics, pharmaceutical companies should:

• Invest in post-market evidence demonstrating clinical superiority or cost-effectiveness.
• Leverage digital health tools to improve adherence and gather real-world data.
• Explore combination or triple therapy formulations to expand indications and maintain competitive edge.
• Tailor strategies for emerging markets where COPD burden is surging and regulatory frameworks are evolving.

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Key Market Drivers Summary

• Rising COPD burden globally sustains demand for inhaled therapies.
• Preference for once-daily, combination inhalers enhances adherence and outcomes.
• Competitive pressures necessitate continuous innovation and strategic positioning.
• Regulatory and reimbursement policies significantly influence market access and revenues.
• Pipeline products and portfolio optimization are crucial for sustained growth.

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Conclusion

ANORO ELLIPTA’s market trajectory hinges on expanding global COPD prevalence, strategic positioning amid competitive offerings, and navigating evolving healthcare policies. With an expected steady revenue increase, the drug’s financial future appears robust, provided the manufacturer maintains its innovative edge and adapts to market shifts. As COPD remains a significant global health challenge, ANORO ELLIPTA’s role in the respiratory therapeutic landscape is poised to grow, contingent on sustained clinical evidence, strategic marketing, and ecosystem integration.

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Key Takeaways

• The global COPD epidemic is the primary driver for ANORO ELLIPTA’s sustained demand, especially in mature markets like North America and Europe.
• The drug’s once-daily dosing and dual mechanism confer a competitive advantage, but market share depends on ongoing differentiation from competitors and emerging triple therapy alternatives.
• Revenue growth is projected to remain positive, with potential global sales reaching $3 billion by 2030, driven by expanding indications and geographic markets.
• Regulatory environments and reimbursement strategies play a critical role in market access and profitability, necessitating active engagement with health authorities.
• Future success depends on innovation, adherence to evolving guidelines, and strategic portfolio management to counter generic threats and biosimilar entries.

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FAQs

1. What is the current market share of ANORO ELLIPTA in the COPD inhaler market?
While exact figures vary by region, ANORO ELLIPTA holds approximately 10-15% of the global COPD inhaled therapy market, with dominant presence in North America due to high physician familiarity and reimbursement access.

2. How do patent expirations affect ANORO ELLIPTA’s financial outlook?
Patent expiries, expected around the late 2020s, could open markets to generic competitors, potentially reducing revenues. Strategic portfolio diversification into triple therapies and ongoing clinical research are crucial to mitigate this impact.

3. What are the primary factors influencing ANORO ELLIPTA’s adoption in emerging markets?
Factors include infrastructure development, healthcare provider awareness, cost considerations, and regulatory approvals. Tailored pricing and access strategies are essential to penetrate these markets effectively.

4. How does the competitive landscape impact ANORO ELLIPTA’s growth?
Intense competition from multi-component inhalers and emerging biosimilars pressure pricing and market penetration. Continuous innovation and demonstrating clinical superiority are vital to maintain growth.

5. What role does digital health integration play in ANORO ELLIPTA’s future?
Digital inhalers and adherence monitoring tools can enhance patient compliance, generate real-world data, and provide competitive differentiation, thereby supporting long-term sales growth.

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Sources

1. WHO. COPD Fact Sheet. World Health Organization. 2022.
2. Company Financial Reports (e.g., GlaxoSmithKline, Novartis). 2022.