FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - Generic Drug Details

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

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

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has three hundred and twenty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

International Patents:	329
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
DailyMed Link:	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE; 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 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

Sponsor	Phase
Parexel International Japan	Phase 3
GlaxoSmithKline	Phase 3
Q2 Solutions, LLC	Phase 3

See all FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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 FLUTICASONE FUROATE; 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	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes			Y

Expired US Patents for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017

International Patents for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Country	Patent Number	Title	Estimated Expiration
Cyprus	2014043
European Patent Office	1960021	DISTRIBUTEUR À UTILISER DANS UN APPAREIL DISTRIBUTEUR DE MÉDICAMENT (MANIFOLD FOR USE IN MEDICAMENT DISPENSER)
Ukraine	95768	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА;АНТАГОНІСТИ МУСКАРИНОВИХ РЕЦЕПТОРІВ АЦЕТИЛХОЛІНУ (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
Brazil	PI0614568	dispensador de medicamento
Norway	20041041

Supplementary Protection Certificates for FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	PA2014019	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	C300664	Netherlands		PRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	CR 2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
1425001	PA2014019,C1425001	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	CA 2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate

Introduction

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, marketed under the brand name Trelegy Ellipta, is a fixed-dose combination inhaled medication used for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and, in some cases, asthma. This article delves into the market dynamics and financial trajectory of this drug, highlighting its development, market performance, cost-effectiveness, and future prospects.

Development and Approval

Trelegy Ellipta is developed by GlaxoSmithKline (GSK), Innoviva, and Theravance Biopharma. The combination includes an inhaled corticosteroid (ICS) fluticasone furoate, a long-acting muscarinic antagonist (LAMA) umeclidinium, and a long-acting beta-agonist (LABA) vilanterol. The drug has been approved by regulatory bodies such as the US Food and Drug Administration (FDA) for the maintenance treatment of COPD in adults who have not achieved adequate control with other therapies[2][4].

Market Performance

Prescription Volume and Revenue

As of 2022, Trelegy Ellipta was the 144th most commonly prescribed medication in the United States, with over 3 million prescriptions. This indicates a significant market presence and demand for the drug. The revenue generated from Trelegy Ellipta has been substantial, contributing to GSK's respiratory portfolio[2].

Competitive Landscape

The COPD treatment market is competitive, with various combination therapies available. However, Trelegy Ellipta's unique triple-component formulation sets it apart, offering a comprehensive approach to managing COPD symptoms. It competes with other combination therapies such as umeclidinium/vilanterol and fluticasone furoate/vilanterol, but its triple therapy has shown superior outcomes in several clinical trials[2][5].

Cost-Effectiveness Analysis

Economic Evaluations

Studies have shown that Trelegy Ellipta is cost-effective compared to dual therapy options. A cost-effectiveness analysis in China demonstrated that the triple therapy (FF/UMEC/VI) is more affordable than the dual therapy (UMEC/VI) when evaluated against the country's three times GDP per capita criterion. The study found that the 20-year treatment costs for FF/UMEC/VI were lower, and the quality-adjusted life years (QALYs) were higher compared to UMEC/VI[3].

Pharmacoeconomic Reviews

In Canada, the Common Drug Review (CDR) by CADTH evaluated the pharmacoeconomic profile of Trelegy Ellipta. The review indicated that Trelegy Ellipta had an incremental cost-effectiveness ratio (ICER) of $21,189 per QALY when compared to fluticasone furoate/vilanterol and $17,022 per QALY when compared to umeclidinium/vilanterol. These findings suggest that Trelegy Ellipta is a cost-effective option for COPD management in certain healthcare systems[5].

Adverse Effects and Safety Considerations

While Trelegy Ellipta is generally well-tolerated, it comes with potential side effects characteristic of its individual components. These include anticholinergic side effects from umeclidinium, cardiovascular effects from vilanterol, and corticosteroid-related side effects from fluticasone furoate. Paradoxical bronchospasm, a life-threatening condition, can also occur, necessitating immediate discontinuation of the treatment[2][4].

Market Dynamics and Trends

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Trelegy Ellipta. Approvals and indications from regulatory bodies like the FDA and the European Medicines Agency (EMA) have expanded the drug's market reach. Ongoing clinical trials, such as the phase III trials in China, continue to support its efficacy and safety profile[1][4].

Patient and Physician Preferences

Patient and physician preferences are influenced by the drug's efficacy, safety, and convenience. Trelegy Ellipta's once-daily dosing regimen and single-inhaler therapy make it a preferred option for many patients and healthcare providers. The drug's ability to consolidate multiple therapies into one product enhances patient compliance and simplifies treatment regimens[2][5].

Pricing and Reimbursement

Pricing and reimbursement policies significantly impact the financial trajectory of Trelegy Ellipta. In various jurisdictions, the drug's cost-effectiveness and clinical benefits have led to favorable reimbursement decisions. However, the drug's high cost can be a barrier in some markets, necessitating negotiations with healthcare payers and governments[3][5].

Future Prospects

Ongoing Research and Development

Ongoing and planned clinical trials will continue to provide evidence on the long-term efficacy and safety of Trelegy Ellipta. For example, the phase III trial in China aims to further establish the drug's role in managing COPD in different patient populations[1].

Market Expansion

Trelegy Ellipta's market is expected to expand as more countries approve the drug for COPD treatment. The drug's approval in new regions and potential indications for asthma will further drive its market growth.

Competitive Strategies

GSK and its partners are likely to employ various competitive strategies to maintain and grow the market share of Trelegy Ellipta. These may include educational programs for healthcare providers, patient support initiatives, and strategic pricing to remain competitive in the market.

Key Takeaways

• Market Presence: Trelegy Ellipta is a widely prescribed medication for COPD, with over 3 million prescriptions in the US as of 2022.
• Cost-Effectiveness: The drug has been shown to be cost-effective compared to dual therapy options in several economic evaluations.
• Regulatory Approvals: Trelegy Ellipta has received approvals from major regulatory bodies, expanding its market reach.
• Patient and Physician Preferences: The drug's once-daily dosing and single-inhaler therapy make it a preferred option for many patients and healthcare providers.
• Future Prospects: Ongoing research, market expansion, and competitive strategies are expected to drive the drug's future growth.

FAQs

Q: What is the primary indication for Trelegy Ellipta?

A: The primary indication for Trelegy Ellipta is the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults who have not achieved adequate control with other therapies.

Q: What are the components of Trelegy Ellipta?

A: Trelegy Ellipta is a combination of an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta-agonist (vilanterol).

Q: Has Trelegy Ellipta been shown to be cost-effective?

A: Yes, several studies have demonstrated that Trelegy Ellipta is cost-effective compared to dual therapy options, particularly in terms of quality-adjusted life years (QALYs) and treatment costs.

Q: What are the potential side effects of Trelegy Ellipta?

A: The potential side effects include anticholinergic side effects from umeclidinium, cardiovascular effects from vilanterol, and corticosteroid-related side effects from fluticasone furoate. Paradoxical bronchospasm is also a possible adverse effect.

Q: Is Trelegy Ellipta approved for use in asthma?

A: While primarily approved for COPD, Trelegy Ellipta is also being studied for use in asthma, particularly in patients who have not achieved adequate control with other therapies.

Sources

1. AdisInsight - Springer: Fluticasone furoate/umeclidinium/vilanterol.
2. Wikipedia: Fluticasone furoate/umeclidinium bromide/vilanterol.
3. PubMed: Cost-effectiveness analysis of fluticasone furoate/umeclidinium bromide/vilanterol.
4. EMA: Trelegy Ellipta, INN-fluticasone furoate/umeclidinium bromide/vilanterol.
5. CADTH: Pharmacoeconomic Review Report for Trelegy Ellipta.