Fluticasone furoate; vilanterol trifenatate - Generic Drug Details

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

Fluticasone furoate; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; vilanterol trifenatate has two hundred and fourteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for fluticasone furoate; vilanterol trifenatate

International Patents:	214
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate; vilanterol trifenatate
DailyMed Link:	fluticasone furoate; vilanterol trifenatate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fluticasone furoate; vilanterol trifenatate

Constraining patent/regulatory exclusivity:

11,116,721*PED

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; vilanterol trifenatate

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

Sponsor	Phase
BI Medical.Inc	Phase 3
York Bioanalytical Solution	Phase 3
Q2 Solutions	Phase 3

See all fluticasone furoate; vilanterol trifenatate clinical trials

Pharmacology for fluticasone furoate; vilanterol trifenatate

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

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone furoate; 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

US Patents and Regulatory Information for fluticasone furoate; vilanterol trifenatate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	9,333,310*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	8,511,304*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	8,746,242*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	8,161,968*PED				Y

Expired US Patents for fluticasone furoate; vilanterol trifenatate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	5,873,360
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	6,759,398
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,101,866
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	RE44874

International Patents for fluticasone furoate; vilanterol trifenatate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1534367
China	101336118	Manifold for use in medicament dispenser
World Intellectual Property Organization (WIPO)	2010097115
Hong Kong	1201762

Supplementary Protection Certificates for fluticasone furoate; vilanterol trifenatate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1425001	PA2014019,C1425001	Lithuania		PRODUCT NAME: VILANTEROLUM; 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
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

Fluticasone furoate; vilanterol trifenatate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluticasone Furoate; Vilanterol Trifenatate

Introduction

Fluticasone furoate and vilanterol trifenatate, commonly known by the brand name Breo Ellipta, is a combination inhalation product used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. This article delves into the market dynamics and financial trajectory of this drug, highlighting its sales trends, pricing strategies, and market positioning.

Market Overview

The market for fluticasone furoate and vilanterol trifenatate is part of the broader respiratory therapeutics market, which has seen significant growth due to the increasing prevalence of respiratory diseases such as COPD and asthma.

Sales Trends

Since its introduction, Breo Ellipta has shown promising sales trends. The drug was first approved by the FDA in 2013, and its sales have been steadily increasing. A report by Research and Markets indicates that the sales of fluticasone furoate and vilanterol have been growing globally, with detailed sales forecasts available until 2021[3].

• Global Sales: The global sales of Breo Ellipta have been driven by its efficacy in treating COPD and asthma. Studies have shown that the combination of fluticasone furoate and vilanterol provides clinically meaningful benefits over single-component treatments, contributing to its market success[2].
• Regional Sales: Sales data by country show varying growth rates, with the drug performing well in major markets such as the United States, Europe, and more recently, India. In India, for instance, the drug was introduced in 2021 and has been prescribed in a significant number of patients with COPD and asthma[4].

Pricing Analysis

Pricing strategies play a crucial role in the market dynamics of pharmaceuticals. For fluticasone furoate and vilanterol, the pricing varies by country and is influenced by several factors including regulatory environments, competition, and patient affordability.

• Country-Specific Pricing: The unit price of Breo Ellipta differs significantly across countries. For example, the price in the United States is generally higher compared to other regions. This variation is due to different healthcare systems, reimbursement policies, and market competition[3].
• Competitive Pricing: The pricing of Breo Ellipta is also influenced by the presence of other ICS/LABA combination products in the market. Manufacturers often adjust prices to remain competitive while ensuring profitability.

Market Forecast

The sales forecast for fluticasone furoate and vilanterol indicates continued growth, driven by increasing demand for effective respiratory treatments.

• Growth Projections: Research and Markets forecasts suggest that the sales of this combination product will continue to rise, driven by growing awareness and adoption in various markets. The report provides detailed forecasts by country, helping stakeholders in market planning and strategic decision-making[3].
• Emerging Markets: The introduction of Breo Ellipta in emerging markets like India has opened new avenues for growth. The drug's once-daily dosing regimen and efficacy in managing COPD and asthma are expected to drive its adoption in these regions[4].

Market Positioning

Fluticasone furoate and vilanterol trifenatate have been positioned as a premium product in the respiratory therapeutics market, leveraging its unique once-daily dosing and the combined benefits of an inhaled corticosteroid (ICS) and a long-acting beta2 agonist (LABA).

• Clinical Efficacy: Studies have demonstrated the clinical efficacy of Breo Ellipta in reducing exacerbations and improving lung function in patients with COPD and asthma. This has helped in positioning the drug as a preferred treatment option among healthcare providers[2].
• Patient Compliance: The once-daily dosing regimen enhances patient compliance, which is a significant factor in the drug's market success. Higher compliance rates contribute to better disease management and reduced healthcare costs in the long term.

Competitive Landscape

The respiratory therapeutics market is highly competitive, with several other ICS/LABA combination products available.

• Competitors: Other notable ICS/LABA combinations include fluticasone propionate/salmeterol and budesonide/formoterol. However, Breo Ellipta's unique formulation and once-daily dosing have helped it maintain a strong market position[2].
• Generic Trends: As patents expire, generic versions of fluticasone furoate and vilanterol may enter the market, potentially impacting the sales of the branded product. However, the complexity of developing generic inhalation products can delay such entries, allowing the branded product to maintain market share for a longer period[3].

Financial Performance

The financial performance of fluticasone furoate and vilanterol trifenatate has been robust, reflecting its strong market position and growing demand.

• Revenue Growth: The revenue generated from Breo Ellipta has been increasing year-over-year, driven by its expanding market presence and higher sales volumes. This growth is expected to continue as the drug penetrates deeper into emerging markets[3].
• Profitability: The profitability of the drug is influenced by factors such as production costs, pricing strategies, and market competition. Despite these factors, Breo Ellipta has maintained a profitable profile for its manufacturer, GlaxoSmithKline (GSK).

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals.

• Approvals and Regulations: Breo Ellipta has received approvals from major regulatory bodies such as the FDA and the European Medicines Agency. Compliance with regulatory requirements is essential for maintaining market presence and ensuring patient safety[2][5].

Patient Utilization

Patient utilization patterns provide insights into how the drug is being prescribed and used in real-world settings.

• Prescription Data: A drug utilization study in India found that Breo Ellipta was prescribed in an almost equal number of patients with COPD and asthma. The majority of patients were switched from previous ICS/LABA treatments, indicating a preference for this once-daily combination product[4].

Key Takeaways

• Growing Sales: Breo Ellipta has shown steady sales growth globally, driven by its efficacy and once-daily dosing regimen.
• Pricing Strategies: The drug's pricing varies by country and is influenced by regulatory environments, competition, and patient affordability.
• Market Forecast: Continued growth is projected, driven by increasing demand in emerging markets.
• Competitive Positioning: The drug is positioned as a premium product with a strong clinical efficacy profile.
• Regulatory Compliance: Compliance with regulatory requirements is crucial for maintaining market presence.

FAQs

Q: What is the primary indication for fluticasone furoate and vilanterol trifenatate? A: The primary indications for fluticasone furoate and vilanterol trifenatate are the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

Q: How does the once-daily dosing regimen of Breo Ellipta impact patient compliance? A: The once-daily dosing regimen of Breo Ellipta enhances patient compliance by simplifying the treatment schedule, which can lead to better disease management and reduced healthcare costs.

Q: What are the key factors influencing the pricing of Breo Ellipta? A: The pricing of Breo Ellipta is influenced by factors such as regulatory environments, competition, and patient affordability, which vary by country.

Q: How does Breo Ellipta compare to other ICS/LABA combination products in the market? A: Breo Ellipta is differentiated by its once-daily dosing regimen and has demonstrated clinical efficacy in reducing exacerbations and improving lung function, making it a preferred treatment option among healthcare providers.

Q: What is the expected impact of generic versions on the market share of Breo Ellipta? A: The entry of generic versions may impact the sales of Breo Ellipta, but the complexity of developing generic inhalation products can delay such entries, allowing the branded product to maintain market share for a longer period.

Sources

1. Australian public assessment report for Fluticasone furoate/vilanterol trifenatate. Therapeutic Goods Administration, 2014.
2. FDA Approval Documents for Breo Ellipta. FDA, 2013.
3. Fluticasone Furoate / Vilanterol Sales, Price Analysis, & Sales Forecast. Research and Markets, 2017.
4. Fluticasone Furoate/Vilanterol Use Trends and Characteristics in India. PubMed, 2023.
5. Fluticasone Furoate; Vilanterol Trifenatate - Draft Guidance. FDA, 2016.