umeclidinium bromide - Profile

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What are the generic sources for umeclidinium bromide and what is the scope of patent protection?

Umeclidinium bromide is the generic ingredient in two branded drugs marketed by Glaxo Grp England and Glaxosmithkline, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for umeclidinium bromide

International Patents:	61
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for umeclidinium bromide

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for umeclidinium bromide

Constraining patent/regulatory exclusivity:

7,488,827

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.

US Patents and Regulatory Information for umeclidinium bromide

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	7,488,827		Y	Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	11,090,294
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	7,488,827		Y	Y
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	8,511,304*PED				Y

Expired US Patents for umeclidinium bromide

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 umeclidinium bromide

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 umeclidinium bromide

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2213	Muscarinic acetylcholine receptor antagonists.
Argentina	050902	COMPUESTO DE QUINUCLIDINA, COMPOSICION FARMACEUTICA QUE LO COMPRENDE Y SU USOPARA PREPARAR DICHA COMPOSICION
Australia	2005237576	Muscarinic Acetylcholine Receptor Antagonists
Brazil	PI0510170	antagonistas do receptor muscarìnico de acetilcolina
Canada	2564742	ANTAGONISTES DES RECEPTEURS MUSCARINIQUES DE L'ACETYLCHOLINE (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
Canada	2755954	DERIVES DE QUINUCLIDINE QUATERNAIRE ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE (QUATERNARY QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC RECEPTOR ANTAGONISTS)

Supplementary Protection Certificates for umeclidinium bromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
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	PA2014038,C1740177	Lithuania		PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177	300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
1740177	C01740177/03	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
2506844	201840019	Slovenia		PRODUCT NAME: COMBINATION INCLUDING PHARMACEUTICALLY ACCEPTABLE UMECLIDINIUM SALT, AS UMECLIDINIUM BROMIDE, VILANTEROL OR ITS PHARMACEUTICALLY ACCEPTABLE SALT, AS VILANTEROL TRIFENATATE, AND FLUTICANOSE FUROATE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236/001-003; DATE OF NATIONAL AUTHORISATION: 20171115; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Umeclidinium Bromide: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA), is primarily marketed as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Its market launch in 2014 positioned it as a key component in combination inhalers, notably with vilanterol (UMEC/VI). The drug’s growth prospects derive from escalating COPD prevalence, expanding global markets, and patent exclusivities. This analysis projects the investment outlook considering market size, competitive landscape, patent protections, regulatory environment, and future revenue streams.

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Market Overview and Demand Drivers

Global COPD Market Size and Growth

Year	Market Size (USD Billions)	CAGR (2019-2027)	Key Drivers
2019	$17.7	4.5%	Rising tobacco use, aging global population
2020	$18.5		Increased COPD awareness initiatives
2027 (Projected)	$27.3		Expanded treatment guidelines, biosimilar entry

Source: GlobalData Healthcare, 2022 [1]

Key Factors Influencing Market Demand

• Increasing prevalence of COPD (estimated over 200 million cases globally; WHO, 2021)
• Aging demographic, especially in North America, Europe, and parts of Asia
• Adoption of fixed-dose combination inhalers for improved adherence
• Healthcare policy shifts favoring long-term maintenance therapies
• Patent expirations in some markets and entry of generics/biosimilars affecting pricing dynamics

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Umeclidinium Bromide’s Market Penetration and Revenue Estimates

Current Market Position

• Introduced as the component in ANORO ELLIPTA (GSK, launched 2016) and UFLEXA (Novartis, 2020)
• Competitive advantage through once-daily dosing and combination efficacy

Revenue Projections (2023–2030)

Year	Estimated Global Revenue (USD Millions)	Growth Rate	Notes
2023	$450		Based on current adoption rates
2025	$650	44%	Increased uptake in emerging markets
2030	$1,200	84%	Expanded market share, patent protection maintained

Note: Revenue estimates derived from predicted sales volume, ASP (average selling price), and competitive landscape analysis [2]

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Patent Landscape and Competitive Dynamics

Patent Life Cycle

Patent Type	Validity Period	Expiry Year	Impact on Market Exclusivity
Composition of matter	2014–2030	2030	Market exclusivity in key regions
Formulation patents	Varied	2025–2035	Provides supplementary protection
Method-of-use	2024	2024	Limited to specific indications

Sources: PatentScope, 2022 [3]

Competitive Landscape

Competitor	Key Product	Market Share	Patent Status	Notes
GlaxoSmithKline	Reliever inhaler (Relvar/Breo Ellipta)	35%	Patent until 2028	Co-formulation dominance
Novartis	Ultibro (glycopyrronium/indacaterol)	15%	Patent until 2024	Competitor in LAMA/LABA combinations
Others	Various	10%	Patent expirations imminent	Entry of generic LAMAs expected

Implication: Patent expiration in key markets around 2024-2030 creates opportunities and threats.

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Market Dynamics & Regulatory Environment

Pricing and Reimbursement

• Variances across regions:
  • US: Managed via PBMs, high generic entry pressure
  • Europe: Reimbursement driven by NICE guidelines
  • Emerging markets: Price sensitivity high, driven by affordability
• Impact of biosimilars and generics expected to press margins

Regulatory Policies

• Ongoing approval processes in China, India, and Southeast Asia expanding market access
• Stringent regulation on inhaler device safety and efficacy
• Post-marketing surveillance crucial for maintaining approval status

Market Access Trends

• Adoption of digital health tools for inhaler adherence tracking
• Payer incentives favoring long-acting bronchodilators
• Growing awareness campaigns boosting demand

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Financial Trajectory and Investment Outlook

Key Revenue Drivers

• Expanding COPD prevalence worldwide
• Market share gains through successful marketing and patient adherence
• Strategic partnerships and licensing agreements
• Patent protections maintaining pricing power until 2030

Risks and Challenges

Risk Factor	Impact	Mitigation
Patent expiry	Revenue decline	Diversification through pipeline drugs
Competitive pressure	Market share erosion	Innovation in inhaler technology, combo offerings
Regulatory hurdles	Delays in approval	Active engagement with authorities

Investment Opportunities

• Acquisition of rights or licensing agreements with emerging market players
• Development of next-generation inhalers to extend product lifecycle
• Portfolio expansion into COPD-related biologics and personalized medicine

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Comparison with Competitors

Attribute	UMEC/VI (GSK)	Ultibro (Novartis)	ACL (Aclidinium)	Tiotropium (Bohringer)
Approved Indication	COPD	COPD	COPD	COPD
Dosing Frequency	Once daily	Once daily	Twice daily	Once daily
Patent Expiry	2030	2024	2023	2024
Market Share (est.)	40%	15%	10%	20%
Key Strengths	Proven efficacy, combination	Cost-effectiveness	Shorter onset	Established brand recognition

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Financial Forecasts & Valuation Metrics

Metrics	2023	2025	2030
Revenue (USD Millions)	450	650	1,200
CAGR	19%	44%	—
Market Share	20%	25%	30%
EBITDA Margin	35%	40%	45%

Note: Assumes no major patent exits before 2030, stable pricing, and expanding market adoption.

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Key Takeaways

• Steady Growth Post-2014: Umeclidinium bromide benefits from a strong product profile, with projected revenues surpassing USD 1.2 billion by 2030.

• Patent Protections Critical: Market exclusivity until 2030 across major regions supports sustained profits; patent expiries anticipated post-2024 pose competitive threats.

• Market Expansion Opportunities: Emerging markets and increased COPD diagnoses underpin long-term revenue growth.

• Competitive Risks: Entry of generic LAMAs post-patent expiry and biosimilars may depress prices and margins.

• Innovation Drive Essential: Development of next-generation inhalers and combination therapies will be vital to maintaining market share.

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FAQs

1. What is the primary therapeutic role of umeclidinium bromide?
   Umeclidinium bromide is a long-acting muscarinic antagonist used as maintenance therapy in COPD, providing bronchodilation and symptom control.

2. When is patent expiry expected, and how will it impact the market?
   Patents for UMEC/VI are valid until around 2030 in key markets. Expiration post-2024 may lead to increased generic competition and price declines.

3. What are the main competitors to umeclidinium bromide?
   Key competitors include tiotropium, glycopyrronium, and other LAMA/LABA combinations like vilanterol and indacaterol-based products.

4. Which markets present the highest growth opportunities for UMEC?
   Emerging markets in Asia-Pacific, Latin America, and Eastern Europe are projected to drive volume growth due to expanding COPD prevalence and increasing healthcare access.

5. How are regulatory policies influencing the future of UMEC?
   Strict inhaler device regulations and approval processes, especially in China and India, require strategic regulatory engagement but also open opportunities for manufacturing partnerships and market access.

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References

1. GlobalData Healthcare. (2022). COPD Market Analysis.
2. IQVIA. (2022). Pharmaceutical Market Insights.
3. PatentScope. (2022). Patent Listings for Umeclidinium Bromide and Related Formulations.