Umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

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

Umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide; vilanterol trifenatate has two hundred and fifty-four patent family members in fifty-one countries.

Two suppliers are listed for this compound.

Summary for umeclidinium bromide; vilanterol trifenatate

International Patents:	254
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for umeclidinium bromide; vilanterol trifenatate
DailyMed Link:	umeclidinium bromide; vilanterol trifenatate at DailyMed

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

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; vilanterol trifenatate

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
Q2 Solutions	Phase 3
SRL Mediserch.Inc	Phase 3

See all umeclidinium bromide; vilanterol trifenatate clinical trials

Pharmacology for umeclidinium bromide; vilanterol trifenatate

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

Anatomical Therapeutic Chemical (ATC) Classes for umeclidinium bromide; vilanterol trifenatate

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; vilanterol trifenatate

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
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	Y

Expired US Patents for umeclidinium bromide; vilanterol trifenatate

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

International Patents for umeclidinium bromide; vilanterol trifenatate

Country	Patent Number	Title	Estimated Expiration
Norway	20043521
Hungary	228508	PHENETHANOLAMINE DERIVATIVES AND PHARMACEUTICAL COMPOSITION CONTAINING THEM
Slovenia	1425001

Supplementary Protection Certificates for umeclidinium bromide; vilanterol trifenatate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	208 50012-2014	Slovakia		PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
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
1425001	2014C/026	Belgium		PRODUCT NAME: VILANTEROL TRIFENATATE; AUTHORISATION NUMBER AND DATE: EU/1/13/886/001 20131114

Market Dynamics and Financial Trajectory for Umeclidinium Bromide; Vilanterol Trifenatate

Last updated: September 24, 2025

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Introduction

The combination of umeclidinium bromide and vilanterol trifenatate represents a significant advancement in the management of chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. This dual bronchodilator therapy integrates a long-acting muscarinic antagonist (LAMA) with a long-acting beta-agonist (LABA), providing sustained symptomatic relief and improving patient outcomes. As an increasingly adopted treatment modality, understanding its market dynamics and financial trajectory is crucial for stakeholders across pharmaceutical firms, investors, and healthcare providers.

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Regulatory Landscape and Market Entry

Umeclidinium/vilanterol combination inhalers have garnered regulatory approval primarily across North America and Europe. The United States Food and Drug Administration (FDA) approved the combination for COPD management in 2014 under the brand Anoro Ellipta (GSK and Innoviva). European Medicines Agency (EMA) approvals followed, promoting widespread clinical adoption.

Regulatory pathways for combination therapies depend on demonstrating safety, efficacy, and bioequivalence relative to monotherapies, with updated guidelines favoring clinical convenience and improved adherence. The timelines for approval influence the initial market entry and subsequent competitive dynamics.

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Market Drivers

1. Rising Prevalence of COPD and Asthma:
The global burden of COPD is projected to reach 4.2 million deaths annually by 2030, with asthma affecting over 300 million worldwide. Aging populations and increased exposure to risk factors like smoking and pollution amplify demand for effective long-term therapies.

2. Clinical Benefits and Patient Adherence:
The convenience of combination inhalers improves adherence, reducing exacerbations and hospitalization rates. Fixed-dose combinations are preferred over multiple separate inhalers, further propelling product adoption.

3. Expanding Global Access:
Key markets, especially in North America and Europe, have well-established healthcare infrastructures facilitating prescription and reimbursement. Emerging markets are witnessing increased acceptance driven by generic availability and partnerships with local distributors.

4. Patent Expiry and Generic Entry:
While patent protections bolster a product’s market exclusivity, impending patent expirations pose threats from generic entrants, potentially impacting prices and volume.

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Competitive Landscape

The market is characterized by key players including GSK (with Anoro Ellipta), Novartis, AstraZeneca, and Teva. The competitive environment emphasizes innovation in inhaler device technologies, improvements in drug formulations, and combination strategies to differentiate products.

Generic and biosimilar entries are expected within the next 5-7 years as patent protections diminish, likely inducing price competition but also expanding overall market volume.

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Financial Trajectory

1. Revenue Growth Patterns
Early years post-approval saw rapid adoption driven by clinical efficacy and marketing efforts. Market analysts project compound annual growth rates (CAGR) of approximately 7-10% for the COPD segment involving umeclidinium/vilanterol from 2023 to 2030. The growth is driven by increasing patient adoption, expanding indications, and geographic penetration.

2. Pricing Strategies and Reimbursement
Premium pricing was initially justified by clinical benefits, but with patent expiries, price erosion is anticipated. Payers are increasingly favoring cost-effective therapies, which could affect margins.

3. Patent Expiry and Generics
Assuming patent protection extends until 2025-2028, a significant decline in revenues from branded formulations could occur starting in 2026. To sustain financial performance, companies are investing in pipeline drugs and combination formats.

4. Market Expansion in Emerging Markets
Emerging markets, accounting for nearly 30% of global COPD prevalence, present a substantial growth avenue. Lower pricing strategies and partnerships with local entities underlie expansion plans, potentially doubling revenues over the next decade.

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Technological and Market Innovation

1. Inhaler Device Innovation:
Development of smarter inhalers with digital tracking improves compliance and enables remote monitoring, potentially increasing therapy adherence and market share.

2. Personalized Medicine:
Genetic and phenotypic profiling may tailor treatment, leading to niche markets that could command premium pricing.

3. Biosimilars and Fixed-Dose Combinations:
Introduction of biosimilars and new fixed-dose combinations with improved safety profiles will influence market boundaries, fostering competition and innovation.

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Regulatory and Economic Risks

• Delays in regulatory approval or rejection due to safety or efficacy concerns could impair financial forecasts.
• Pricing pressures from payers, especially in cost-conscious health systems, threaten profit margins.
• Patent cliffs open opportunities for generics but reduce exclusivity-driven revenues.

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Market Outlook and Strategic Recommendations

The umeclidinium bromide/vilanterol triflate combination holds a strong position within COPD management. Its financial trajectory depends heavily on patent lifecycle management, regulatory approvals, market expansion efforts, and innovation adoption.

Strategic actions include:

• Investing in pipeline diversification to mitigate patent expiry impact.
• Enhancing device technology to improve adherence and clinical outcomes.
• Strengthening presence in untapped emerging markets.
• Engaging in strategic licensing or partnership agreements to expand indications and mitigate competitive pressures.

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Key Takeaways

• The global demand for dual bronchodilator therapies like umeclidinium/vilanterol is driven by rising COPD and asthma prevalence, aging populations, and preference for simplified treatment regimens.
• Regulatory approvals in major markets with robust reimbursement frameworks underpin the revenue growth, expected to sustain a CAGR of approximately 7-10% until patent expiration prompts market adjustments.
• The impending patent expiry around 2025-2028 will likely result in significant revenue decline from branded formulations but also creates opportunities for generic manufacturers and biosimilar entrants.
• Market expansion into emerging regions offers high-growth potential, supported by lower priced formulations and strategic partnerships.
• Continuous innovation, including inhaler device improvements and personalized medicine approaches, will be key to maintaining competitive advantage.

Overall, stakeholders should emphasize lifecycle management, diversification, and technological innovation to optimize financial trajectories in this competitive landscape.

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FAQs

Q1: When is the patent for umeclidinium/vilanterol expected to expire?
A1: The primary patents for brands like Anoro Ellipta are projected to expire around 2025-2028, after which generic competition is expected to intensify.

Q2: What are the main competitors to umeclidinium/vilanterol combination inhalers?
A2: Major competitors include other LAMA/LABA combinations such as tiotropium/olodaterol and glycopyrrolate/formoterol, produced by companies like Boehringer Ingelheim and Novartis.

Q3: How does reimbursement influence the market adoption of these drugs?
A3: Reimbursement policies significantly impact prescription rates; favorable reimbursement increases patient access, while restrictive policies can constrain sales.

Q4: What role does technological innovation play in the future of this market?
A4: Innovations such as smart inhalers and digital health tools improve adherence and monitoring, positively affecting market growth and patient outcomes.

Q5: How are emerging markets influencing the global market forecast?
A5: Growing COPD prevalence, economic development, and healthcare infrastructure improvements in regions like Asia-Pacific bolster expansion and revenue prospects.

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Sources:

1. [1] GSK. ("Anoro Ellipta" FDA approval documents, 2014).
2. [2] MarketsandMarkets. (Global COPD therapeutics market report, 2022).
3. [3] IQVIA. (Global prescription data, 2022).
4. [4] EvaluatePharma. (Pharmaceutical R&D pipeline and patent landscapes, 2022).