FLOVENT DISKUS 50 Drug Patent Profile

Which patents cover Flovent Diskus 50, and what generic alternatives are available?

Flovent Diskus 50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 50 is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flovent Diskus 50

A generic version of FLOVENT DISKUS 50 was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT DISKUS 50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	19
Patent Applications:	571
DailyMed Link:	FLOVENT DISKUS 50 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 50

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

Sponsor	Phase
Becro Ltd.	Phase 1
Respirent Pharmaceuticals Co Ltd.	Phase 1
Respirent Pharmaceuticals Co Ltd.	Phase 3

See all FLOVENT DISKUS 50 clinical trials

Pharmacology for FLOVENT DISKUS 50

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 50

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	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000	6,536,427*PED
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000	4,335,121*PED
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000	6,792,945*PED

International Patents for FLOVENT DISKUS 50

See the table below for patents covering FLOVENT DISKUS 50 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H04220266	INHALER
Ireland	862287
Cyprus	2014	Medicament pack

Supplementary Protection Certificates for FLOVENT DISKUS 50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117

Market Dynamics and Financial Trajectory for FLOVENT DISKUS 50

Last updated: July 29, 2025

Introduction

FLOVENT DISKUS 50, a medication developed by GlaxoSmithKline (GSK), represents a significant player within the respiratory therapeutic category, specializing in asthma and chronic obstructive pulmonary disease (COPD) management. Its active component, fluticasone propionate, is a potent inhaled corticosteroid that has established a predominant position across global markets. This analysis delineates the market dynamics influencing FLOVENT DISKUS 50 and projects its financial trajectory amid evolving pharmaceutical landscapes.

Market Overview

FLOVENT DISKUS 50 predominantly addresses respiratory ailments, which afflict approximately 339 million individuals globally, with prevalence rates rising due to environmental and lifestyle factors [1]. The demand for inhaled corticosteroids (ICS) like fluticasone correlates strongly with increasing incidence of asthma and COPD, regions’ healthcare policies, and advancements in drug delivery technologies.

Competitive Landscape

GSK maintains a dominant position through FLOVENT DISKUS, which faces competition from several long-acting corticosteroids (ICS) brands, such as Seretide (Fluticasone/Salmeterol) by AstraZeneca and Symbicort (budesonide/formoterol) by AstraZeneca. The market share erosion or growth hinges on efficacy, safety profiles, pricing strategies, and regulatory approvals.

Regulatory Environment

Regulatory agencies such as the FDA and EMA have tightened safety parameters around inhaled corticosteroids, especially concerning oral corticosteroid-sparing protocols and pneumonia risk assessment [2]. Such regulations influence clinician prescribing habits and insurer reimbursement policies, directly impacting FloVENT DISKUS 50’s sales trajectory.

Market Penetration and Adoption

Historically, FloVENT DISKUS has enjoyed robust adoption owing to its once-daily dosing and targeted delivery system, which improve adherence. However, uptake varies by region, influenced by factors like healthcare infrastructure, patient awareness, and formulary placements.

Market Dynamics Influencing FLOVENT DISKUS 50

1. Rising Prevalence of Respiratory Diseases

Increasing global asthma and COPD prevalence drives sustained demand for inhaled corticosteroids. Urbanization, pollution, smoking, and aging populations contribute to this trend, offering a prolonged growth outlook for FLOVENT DISKUS 50.

2. Innovation and Formulation Updates

Technological advancements in inhaler devices, such as improved airflow mechanics and digital tracking, escalate competition but also provide opportunities for FLOVENT DISKUS 50 to enhance adherence and clinical outcomes. GSK’s continuous research on drug reformulation underpins its competitive edge.

3. Pricing and Reimbursement Policies

Pricing pressures, especially in generic-friendly markets like the US and Europe, influence margins. Reimbursement policies favoring cost-effective therapies further pressure prices but can expand access, facilitating broader adoption of FLOVENT DISKUS 50.

4. Patent Expiry and Generic Competition

The expiration of primary patents on Fluticasone Propionate compounds is imminent in key markets, risking erosion of exclusivity. However, GSK’s strategic pipeline investments and lifecycle management (e.g., new delivery systems or combination products) aim to mitigate revenue losses.

5. COVID-19 Pandemic Impact

The pandemic has reframed respiratory disease management, emphasizing telemedicine and e-prescriptions. While initial disruptions curtailed sales, increased respiratory health awareness may catalyze long-term demand for inhaled corticosteroids.

Financial Trajectory Analysis

Revenue Projections

GSK’s respiratory franchise, supported by FLOVENT DISKUS 50, posted revenues of approximately £1.2 billion annually pre-pandemic. Given the rising burden of respiratory diseases and consistent demand for ICS, forecasts indicate a compound annual growth rate (CAGR) of 3-5% over the next five years [3].

Margins and Cost Structures

Operating margins for GSK’s respiratory segment hover around 30%. Patent expirations and increased competition, especially from generic formulations, may compress margins by 5-8%. Conversely, investments in digital health integrations and delivery innovations could offset margin pressures via premium pricing.

Market Penetration Strategies

GSK’s strategy involves expanding into emerging markets, where asthma prevalence is rising but access remains limited. Pricing strategies tailored to economic contexts and local health policies can bolster sales of FloVENT DISKUS 50.

Pipeline and Lifecycle Management

Introduction of combination therapies (e.g., inhaled corticosteroid/long-acting beta-agonist) and remanufactured formulations are poised to sustain revenue streams. These innovations aim to extend FloVENT DISKUS’s lifecycle and capture evolving market segments.

Risks to Financial Trajectory

Key risks include patent cliffs, regulatory hurdles, and emergent generic competition. Market saturation in mature regions and potential adverse safety profiles impacting prescribing behaviors also pose threats to growth assumptions.

Future Outlook

The forecast for FLOVENT DISKUS 50 suggests a cautiously optimistic trajectory driven by increasing respiratory disease prevalence, technological innovation, and strategic lifecycle extensions. However, the competitive and regulatory landscape necessitates ongoing adaptation. GSK’s ability to innovate, penetrate emerging markets, and navigate patent challenges will be fundamental to its financial stability.

Key Takeaways

• Growing global respiratory disease burden underpins sustained demand for FLOVENT DISKUS 50, with regional disparities influencing market strategies.
• Innovation in inhaler technology and combination therapies remains critical for maintaining competitive edge and extending product lifecycle.
• Patent expirations necessitate proactive lifecycle management to mitigate revenue erosion.
• Pricing strategies and reimbursement policies significantly impact market penetration and profit margins.
• The evolving regulatory environment mandates continuous safety and efficacy assessments, influencing prescribing trends and market access.

FAQs

1. How does FLOVENT DISKUS 50 compare to other inhaled corticosteroids in terms of efficacy?
FLOVENT DISKUS 50 offers proven efficacy in reducing asthma and COPD exacerbations, with a well-established safety profile. Its once-daily dosing enhances adherence, often leading to better clinical outcomes compared to other ICS formulations.

2. What is the impact of patent expiry on FLOVENT DISKUS 50’s market share?
Patent expiry risks generic competition, which can substantially reduce sales margins and market share. GSK’s proactive lifecycle management, including new formulations and combination therapies, aims to offset this impact.

3. Are there recent regulatory changes affecting FLOVENT DISKUS 50 sales?
Yes. Regulatory agencies have increased scrutiny over ICS safety profiles, emphasizing pneumonia risk and appropriate prescribing. These changes influence clinician choices but have not significantly curtailed FLOVENT DISKUS 50’s market presence.

4. Which emerging markets present growth opportunities for FLOVENT DISKUS 50?
Regions such as China, India, and parts of Latin America exhibit rising respiratory disease prevalence and expanding healthcare infrastructure, offering significant growth prospects.

5. How does digital health innovation influence FLOVENT DISKUS 50’s future?
Integration of digital inhaler technology enhances adherence tracking and remote patient management, potentially leading to better clinical outcomes and increased demand for fluorinated corticosteroid inhalers like FLOVENT DISKUS 50.

References

[1] World Health Organization. (2022). Global Asthma Report.
[2] U.S. Food and Drug Administration. (2021). Safety Communications on Inhaled Corticosteroids.
[3] GSK Annual Report 2022.
[4] MarketWatch. (2022). Respiratory Drugs Market Analysis.