UMECLIDINIUM BROMIDE - Generic Drug Details

What are the generic sources for umeclidinium bromide and what is the scope of freedom to operate?

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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide has sixty-two patent family members in thirty-six countries.

There are two drug master file entries for umeclidinium bromide. One supplier is listed for this compound.

Summary for UMECLIDINIUM BROMIDE

International Patents:	62
US Patents:	9
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	21
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UMECLIDINIUM BROMIDE
DailyMed Link:	UMECLIDINIUM BROMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for UMECLIDINIUM BROMIDE

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 UMECLIDINIUM BROMIDE

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
GlaxoSmithKline	Phase 4
BI Medical.Inc	Phase 3

See all UMECLIDINIUM BROMIDE clinical trials

Pharmacology for UMECLIDINIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for UMECLIDINIUM BROMIDE

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes			Y	Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes					Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes

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
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014

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
Eurasian Patent Organization	200601991	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА
Hungary	E031304
Taiwan	I363759
Morocco	28631	ANTAGONISTES DES RECEPTEURS MUSCARINIQUES DE L'ACETYLCHOLINE

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	300942	Netherlands		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION 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
1740177	C300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Umeclidinium Bromide

Last updated: July 29, 2025

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Introduction

Umeclidinium bromide (UMEC) is a long-acting muscarinic antagonist (LAMA) primarily developed for the management of chronic obstructive pulmonary disease (COPD). Since its initial approval, UMEC has established itself as a vital component within combination therapies targeting respiratory conditions. This analysis delineates the evolving market landscape, key drivers influencing its financial performance, and future growth potential.

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Market Overview

Historical Development and Approval Timeline

Umeclidinium bromide received its initial approval in 2014 for use in COPD management in the United States and Europe. It was introduced as a once-daily inhalation therapy, providing sustained bronchodilation. Its approval was part of a broader move towards long-acting bronchodilators, which have become the backbone of COPD treatment protocols.

Current Market Position

UMEC is marketed primarily through combination inhalers, notably with vilanterol (as in Anoro Ellipta), which enhances its efficacy by integrating a LAMA with a long-acting beta-agonist (LABA). This fixed-dose combination caters to high-care COPD patients requiring comprehensive bronchodilation.

Key Market Players

Primary manufacturers include GlaxoSmithKline (GSK), which developed and commercializes the drug through its partnership with companies like Innoviva. Other competitors develop alternative LAMAs, such as tiotropium and glycopyrrolate, influencing UMEC's market share.

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Market Dynamics

Drivers

• Rising COPD Prevalence: According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), COPD affected over 384 million people worldwide in 2020. The increasing aging population and environmental factors drive demand for effective long-term therapies like UMEC.
• Efficacy of Combination Therapy: Evidence favors fixed-dose combinations involving UMEC for improved symptom control and reduced exacerbations. This positions UMEC-based inhalers as first-line treatments.
• Regulatory Approvals and Expansions: Continuous approvals for novel formulations and indications broaden market access, particularly in emerging markets targeting COPD and potentially asthma.
• Patient Preference for Once-Daily Dosing: The convenience of once-daily regimens improves adherence, bolstering demand.

Restraints

• Generic Competition: As patents expire, lower-cost generics or biosimilars may erode revenues, especially in price-sensitive markets.
• Market Saturation: The COPD inhaler market is highly competitive with entrenched brands like tiotropium (Spiriva) and newer entrants, leading to pressure on pricing.
• Patient Adherence Challenges: Despite simplified dosing, inhaler technique errors and adherence issues persist, impacting therapeutic outcomes and market growth.

Opportunities

• Expansion into Emerging Markets: Growing healthcare infrastructure and COPD awareness make regions like Asia-Pacific attractive for UMEC adoption.
• Development of New Combinations: Incorporating UMEC into triple therapy options (LAMA + LABA + corticosteroids) could unlock additional growth avenues.
• Digital Health Integration: Digital inhalers and adherence tracking can differentiate products and improve patient outcomes.

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Financial Trajectory

Revenue Trends

Since its launch, UMEC’s revenues have steadily increased, driven by rising COPD prevalence and market penetration of combination inhalers. According to market intelligence reports, UMEC-containing products contribute significantly to GSK’s respiratory division revenues, with estimations indicating a compound annual growth rate (CAGR) of approximately 6-8% between 2018 and 2022.

Impact of Patent Expirations

Patent exclusivity is crucial for revenue stability. GSK's key UMEC patent protection is expected to expire in the mid-2020s, which could introduce biosimilars or generics that threaten profit margins. However, strategic patent extensions and formulation improvements may mitigate this risk.

Pricing and Reimbursement Dynamics

Pricing strategies vary across markets. Western markets emphasize value-based pricing aligned with clinical benefits, while price sensitivity in emerging economies necessitates affordability measures. Reimbursement policies significantly influence sales volumes; favorable policies in large markets like the US and Europe support steady revenue streams.

Investment and R&D Focus

Pharmaceutical companies are investing heavily in developing next-generation formulations of UMEC and combination therapies, aiming to extend product lifecycle and maintain competitive advantage. These investments are reflected in R&D budgets and clinical trial pipelines.

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Future Outlook and Market Forecasts

Market forecasts project that UMEC's role will expand, propelled by:

• Growing COPD burden: The WHO estimates COPD will be the third leading cause of death globally by 2030.
• Product pipeline advancements: Innovations such as triple-inhaler therapies are expected to enhance efficacy and compliance.
• Regulatory support: Expedited approval pathways for novel formulations and indications are likely to facilitate faster market entry.

According to industry reports, the global COPD inhaler market, with UMEC as a significant contributor, is expected to grow at a CAGR of approximately 7% through 2027, reaching a valuation exceeding USD 12 billion.

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Market Challenges and Competitive Landscape

While UMEC has a firm foothold, competition remains intense. Competitors like Boehringer Ingelheim’s tiotropium and AstraZeneca’s inhaled therapies challenge UMEC’s market share. Additionally, innovations in oral or novel delivery systems could disrupt inhaler reliance.

Emerging biosimilars threaten exclusivity and control over pricing, necessitating strategic patent management and continued innovation.

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Strategic Recommendations

• Focus on pipeline expansion, including triple therapy formulations and new indications.
• Enhance adherence strategies via digital inhalers and patient engagement programs.
• Expand into emerging markets with tailored pricing models and localized marketing.
• Invest in patent protection and formulation improvements to extend exclusivity.
• Forge partnerships for clinical studies exploring additional indications or combination regimens.

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Key Takeaways

• Umeclidinium bromide remains a key player in COPD management, with a stable growth trajectory driven by increasing disease prevalence and combination therapy adoption.
• Patent expirations pose revenue risks, but strategic innovation and market expansion can mitigate these effects.
• The global COPD inhaler market is poised for robust growth, with UMEC positioned to benefit from emerging regional opportunities.
• Competitive pressures necessitate continuous innovation, digital health integration, and strategic patent management.
• The drug’s financial trajectory hinges on market penetration, regulatory support, and evolving treatment paradigms, with expected revenues to rise steadily over the coming years.

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FAQs

1. What are the primary therapeutic applications of umeclidinium bromide?
Umeclidinium bromide is primarily indicated for long-term maintenance treatment of COPD, providing bronchodilation to improve airflow and reduce exacerbations. It is often combined with other agents such as vilanterol to enhance efficacy.

2. How does umeclidinium bromide compare with other LAMAs?
UMEC offers comparable efficacy to other LAMAs like tiotropium and glycopyrrolate, with the advantage of once-daily dosing and flexible combination options. Its market share is increasingly driven by its use in fixed-dose inhalers and combination therapies.

3. What are the key factors influencing UMEC’s market growth?
Growing COPD prevalence, innovative combination therapies, regulatory approvals, patient adherence, and geographic expansion are primary growth drivers. Patent expiration and competition are notable risks.

4. What is the outlook for UMEC’s revenues post-patent expiration?
Expected patent expiry in mid-2020s could lead to generic entry, impacting revenues. However, ongoing innovation, new formulations, and regulatory approvals for additional indications can sustain growth.

5. Are there emerging research areas involving umeclidinium bromide?
Yes, research into triple inhaler therapies, new delivery mechanisms, and exploration of uses beyond COPD—such as asthma or other respiratory conditions—are ongoing to broaden UMEC’s therapeutic scope.

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References

1. GSK Annual Reports and Investor Presentations.
2. Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2022.
3. Industry Market Research Reports on COPD Inhaler Market, 2022-2027.
4. WHO Global Health Estimates, 2021.
5. Patent information from Pharmaceutics Patent Databases.