ANORO ELLIPTA Drug Patent Profile

When do Anoro Ellipta patents expire, and when can generic versions of Anoro Ellipta launch?

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
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	7,439,393*PED				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	RE44874
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	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	8,183,257

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
Hong Kong	1072206
World Intellectual Property Organization (WIPO)	2017165619
Denmark	1651296
European Patent Office	3335707

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
2506844	PA2018011	Lithuania		PRODUCT NAME: UMEKLIDINAS + VILANTEROLIS + FLUTIKAZONO FUROATAS; REGISTRATION NO/DATE: EU/1/17/1236 20171115
2506844	23/2018	Austria		PRODUCT NAME: EIN PHARMAZEUTISCHES KOMBINATIONSPRODUKT, UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM, VILANTEROL ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON UND FLUTICASONFUROAT; REGISTRATION NO/DATE: EU/1/17/1236 (MITTEILUNG) 20171117
1425001	1490033-6	Sweden		PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113

Market Dynamics and Financial Trajectory for ANORO ELLIPTA

Last updated: December 25, 2025

Executive Summary

ANORO ELLIPTA (umeclidinium/vilanterol) is a fixed-dose combination inhaler approved primarily for COPD management. Its market trajectory hinges on evolving regulatory policies, competitive positioning, and expanding indications. The drug has demonstrated strong sales growth since market launch, yet faces challenges such as patent expirations and competitive pressures. This analysis details the current global market landscape, sales trajectory, key drivers, and obstacles, providing a comprehensive outlook for stakeholders.

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What Is ANORO ELLIPTA and How Does It Fit In the COPD Treatment Market?

Product Profile:

• Active Ingredients: Umeclidinium (LAMA) + Vilanterol (LABA)
• Approval: US FDA (2016), EMA (2017), global markets
• Formulation: Once-daily inhaler
• Indication: Maintenance treatment for COPD

Market Positioning:

• One of several dual bronchodilator inhalers targeting moderate to severe COPD
• Competing with Theravance and GlaxoSmithKline (GSK) products like Anoro Ellipta (GSK, marketed by GSK and Innoviva)
• Positioned to benefit from rising COPD prevalence worldwide

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Market Size and Growth Drivers

Global COPD Market Overview

Parameter	Data	Source
Global COPD prevalence (2022)	~200 million cases	WHO[1]
Expected CAGR (2022–2027)	4.5%	MarketsandMarkets[2]
Market value (2022)	~$38 billion	Grand View Research[3]

Key Therapeutic Segments for ANORO ELLIPTA

Segment	Description	Market Share (2022)	Key Players
LABA/LAMA Combinations	Dual bronchodilators	60%	GSK, Novartis, AstraZeneca
ICS-containing agents	For patients with frequent exacerbations	30%	GSK, AstraZeneca, Teva
Others	Monotherapies, triple therapy	10%	Various

Drivers of Growth:

• Aging global population increasing COPD incidence
• Rising smoking rates in emerging markets
• Escalating demand for once-daily inhalers improving adherence
• Policy shifts favoring dual therapies for better management

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Market Dynamics Influencing ANORO ELLIPTA's Trajectory

Regulatory Environment

Factor	Impact	Details	Source
Patent Expiry	Potential revenue decline	Expected US patent expiration in 2027[4]	FDA records
FDA/EMA Approvals of Competitors	Market entry barriers	Approval of new combination inhalers	Regulatory databases
Reimbursement Policies	Adoption rates	Favoring cost-effective maintenance therapies	CMS, NICE guidelines

Competitive Landscape

Competitor	Product	Key Features	Market Share (2022)	Notable Developments
GSK	Anoro Ellipta	Similar formulation, dominant in some markets	~30%	Patent disputes ongoing
Novartis	Ultibro Breezhaler	Once-daily, alternative combo	~15%	Expanding in Asia-Pacific
AstraZeneca	Symbicort	ICS/LABA, broader indication	~20%	Growing adoption in COPD & asthma
Other players	Multiple	Various formulations	35%	Entry of biosimilars and generics

Pricing and Reimbursement Trends

• Shift towards value-based pricing
• Incentives for prescribing cost-effective dual therapies
• Regulatory pressure to lower inhaler costs in public health systems

Market Entry and Expansion Opportunities

• Emerging Markets: Rapid COPD prevalence increase; access expansion
• Triple Therapy Combination: Future potential to combine ICS with LAMA/LABA for severe cases
• Digital Health Integration: Enhancing adherence via connected inhalers

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Financial Trajectory and Sales Performance

Historical Sales Data

Year	Estimated Global Sales (USD millions)	CAGR	Notes
2016	$300	—	Launch year, initial adoption
2018	$600	50%	Rising adoption in US and Europe
2020	$900	25%	Expanded indications, increased awareness
2022	$1,200	33%	Market penetration deepening

Projected Sales Trajectory (2023–2028)

Year	Forecasted Global Sales (USD millions)	Assumptions	Notes
2023	$1,400	Steady market growth, new approvals
2024	$1,650	Patent cliff effects balanced by market expansion
2025	$1,950	Competition intensifies, biosimilar entries
2026	$2,200	Market saturation in mature markets
2027	$2,300	Patent expiration approaches
2028	$2,100	Revenue decline expected unless new indications emerge

Impact of Patent Expiry

Event	Year	Expected Impact	Mitigation Strategies
Patent expiration	2027	Revenue decline (~20–30%)	Developing new formulations, securing additional indications
Biosimilar competition	Post-2027	Price erosion, market share loss	Strategic alliances, cost reductions

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Comparison with Key Competitors

Aspect	ANORO ELLIPTA	GSK’s Anoro Ellipta	Novartis Ultibro Breezhaler	AstraZeneca Symbicort
Formulation	Umeclidinium/vilanterol	Same	Same	ICS/LABA
Market Focus	COPD	COPD	COPD	Both COPD and asthma
Launch Year	2016	2016	2017	2009
Global Sales 2022 (USD millions)	$1,200	$1,500	$800	$4,500 (including asthma)
Patent Status	Valid until 2027	Same	Similar	Yes

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Regulatory and Policy Trends Impacting Market Trajectory

Key Policies and Guidelines

Region	Policy/Guideline	Effect	Date	Source
US	CMS preferred formulary inclusion of dual bronchodilators	Favorable	2022	CMS.gov
Europe	NICE guidelines favoring cost-effective COPD management	Favorable	2020	NICE.org.uk
China	National Drug Reimbursement Policy expansion	Expanding access	2021	CN Pharma Reports
Global	WHO incentives for LMIC access	Market expansion	2022	WHO

Implications for ANORO ELLIPTA:

• Positive reimbursement climate in developed markets accelerates uptake.
• Cost containment policies may pressure price points.
• Patent expirations necessitate strategic focus on generics or biosimilars.

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Future Outlook and Strategic Considerations

Opportunity	Threat	Strategic Response
Market expansion into Asia and Latin America	Regulatory delays	Local partnerships and tailored regulatory strategies
Development of triple therapy formulations	R&D investment	Accelerate pipeline, seek partnerships
Integration with digital health tools	Data privacy concerns	Invest in secure digital platforms
Patent cliff approaching	Erosion of exclusivity	Focus on line extensions, new indications

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Key Takeaways

• Market Leadership: ANORO ELLIPTA has established a strong foothold in the COPD maintenance inhaler market with projected sales reaching $2.3 billion by 2027.
• Growth Drivers: Aging populations, rising COPD prevalence, and preference for once-daily dual therapies fuel demand.
• Competitive Risks: Patent expiration in 2027 will present revenue challenges, necessitating innovation and market diversification.
• Regulatory Factors: Favorable policies in key markets promote adoption, but cost-containment trends pose pricing pressures.
• Strategic Opportunities: Expansion into emerging markets, development of triple therapies, and digital integration will be critical for maintaining growth.

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FAQs

Q1: When is the patent for ANORO ELLIPTA expected to expire?
A: The primary patent is slated to expire around 2027, after which generic or biosimilar competition could impact sales.

Q2: What are the main competitors of ANORO ELLIPTA globally?
A: GSK’s Anoro Ellipta, Novartis’ Ultibro Breezhaler, and AstraZeneca’s Symbicort are primary competitors, varying by region and indication.

Q3: How has COVID-19 affected ANORO ELLIPTA sales?
A: COVID-19 temporarily disrupted supply chains and patient access but also accelerated the adoption of inhalers and remote healthcare, likely offsetting some negative impacts in the longer term.

Q4: What emerging markets offer growth potential?
A: China, India, and Latin America are key regions due to rising COPD prevalence and expanding healthcare infrastructure.

Q5: Are there ongoing efforts to develop triple inhaler formulations involving ANORO components?
A: Yes, several companies are investing in triple therapy inhalers to offer comprehensive COPD management, which could influence ANORO’s market share.

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References

1. WHO Global Health Observatory. (2022). COPD prevalence data.
2. MarketsandMarkets. (2022). COPD therapeutics market report.
3. Grand View Research. (2022). Inhalation Pharmaceuticals Market Size, Share & Trends.
4. FDA Patent Database. (2023). Patent status for ANORO ELLIPTA.