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

Umeclidinium bromide has sixty-one 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:	61
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	22
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
University of Alabama at Birmingham	PHASE2
GlaxoSmithKline	PHASE4
GlaxoSmithKline	Phase 4

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
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
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		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			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
Portugal	2570128
Taiwan	I363759
Luxembourg	92565
Peru	20060259	COMPUESTOS DE QUINUCLIDINA COMO ANTAGONISTAS DEL RECEPTOR DE ACETILCOLINA MUSCARINICO
Eurasian Patent Organization	015033	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
Cyprus	1118082

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	C20140032 00132	Estonia		PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
2506844	122018000060	Germany		PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM (EINSCHLIESSLICH UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (EINSCHLIESSLICH VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2506844	CA 2018 00023	Denmark		PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117
1740177	2014/057	Ireland		PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428

UMECLIDINIUM BROMIDE Market Analysis and Financial Projection

Last updated: February 14, 2026

Market Dynamics and Financial Trajectory for Umeclidinium Bromide

Overview

Umeclidinium bromide (UMECLIDINIUM) is a long-acting muscarinic antagonist (LAMA) used primarily in inhalation therapy for chronic obstructive pulmonary disease (COPD). It is marketed mainly as part of combination therapies to manage airflow obstruction. Since its approval, Umeclidinium bromide has established a niche in COPD treatment, influencing market share and R&D incentives.

Regulatory and Patent Landscape

Approved by the FDA in 2017 under the brand name Incruse Ellipta, Umeclidinium bromide holds exclusivity until 2030, shaping its market timeline. The patent landscape includes U.S. patents expiring between 2028 and 2030, with extension efforts ongoing. Patent expirations exert pressure on pricing and sales volume growth.

Market Size and Growth Factors

The COPD global market was valued at $27 billion in 2022 and is projected to surpass $40 billion by 2028, with an estimated compound annual growth rate (CAGR) of approximately 6.8%. Umeclidinium bromide forms a segment within this, driven by increasing COPD prevalence (over 200 million cases globally as of 2021) and a shift toward inhaled LAMA therapies.

Key growth drivers include:

• Aging Population: Older demographics increase COPD cases.
• Therapeutic Preference: LAMAs are preferred over older therapies like beta-agonists due to better safety profiles.
• Innovation: Development of fixed-dose combination inhalers (e.g., with vilanterol or fluticasone) enhances adherence and efficacy.

Competitive Position

Major competitors: Tiotropium bromide (Spiriva), Glycopyrronium (Seebri), and Bryostatin (Brovana). Umeclidinium’s market share relies on patient preferences, formulary placements, and physician acceptance.

In 2022, Umeclidinium Ellipta held roughly 10% of the COPD inhaler market in the U.S., behind Spiriva (approximately 25%). The product's growth remains constrained by patent cliffs expected around 2030 and competitive pressure from emerging therapies.

R&D and Pipeline Activities

Current research focuses on:

• Combination therapies: Umeclidinium with vilanterol (UMEC/VI) approved since 2017, expanding therapeutic options.
• Indications extension: Exploring use in asthma and other obstructive airway diseases.
• Novel formulations: Investigating Dry Powder Inhalers (DPIs) and alternative delivery systems to improve compliance.

Pipeline developments aim to improve onset of action, reduce side effects, and extend patent protections further through formulation innovations.

Financial Trajectory Projections

Projected revenue growth for Umeclidinium bromide portfolio components hinges on:

• Market penetration: Continued growth in COPD patients on inhaled therapies.
• Pricing strategies: Impacted by generic competition post-2030.
• Regulatory changes: Potential for new indications influencing overall revenue.

Estimates suggest:

• 2022: Revenue at approximately $150 million globally.
• 2023-2028: Compound annual growth rate (CAGR) of roughly 5%, driven by increased COPD diagnosis and combination use.
• Post-2030: Revenue decline anticipated due to patent expiry and subsequent generic entry, with significant pricing erosion.

Pricing and Reimbursement Trends

Umeclidinium bromide’s pricing varies globally. In the U.S., a 30-day supply costs approximately $300–$400 (cash price). Payer coverage and formulary inclusion influence accessibility. Price erosion occurs as generics enter markets, with discounts of 20–40% typical post-generic approval.

Reimbursement policies favor fixed-dose combinations with insurance providers, which can enhance market penetration, but also restrict revenue growth once patent protections diminish.

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Key Takeaways

• Umeclidinium bromide is an established COPD treatment with a stable but mature market position.
• Market growth is driven by aging demographics and inhaler therapy preferences.
• Patent expirations around 2030 will impact revenue, encouraging innovation and pipeline diversification.
• Competition from other LAMAs and combination therapies limits market share expansion.
• R&D efforts aim to extend indications and improve delivery systems, potentially offsetting patent-related income declines.

FAQs

1. How does Umeclidinium bromide compare to other LAMAs in efficacy?
Clinical trials show Umeclidinium has comparable efficacy to tiotropium and glycopyrronium in reducing COPD exacerbations and improving lung function.

2. When will patent expiry affect Umeclidinium bromide’s revenue?
Patent protections are expected to expire around 2030, after which generic versions are likely to enter the market.

3. What are the main areas of innovation for Umeclidinium bromide?
Focus areas include combination inhalers (with vilanterol or fluticasone), alternative delivery systems like dry powder inhalers, and extensions to other respiratory conditions.

4. What are the risks associated with Umeclidinium bromide's market?
Patent expiration, price erosion, competition from newer therapies, and regulatory changes pose risks to sustained revenue growth.

5. How might COVID-19 impact the COPD drug market and Umeclidinium bromide sales?
Pandemic-related disruptions temporarily slowed new patient diagnoses, but increased respiratory disease research and remote healthcare may sustain long-term demand.

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References

[1] Global COPD Market. MarketWatch, 2023.
[2] U.S. FDA drugs database, 2023.
[3] Market data on COPD. IQVIA, 2022.
[4] Patent filings and expiration dates. USPTO, 2023.