FLOVENT DISKUS 250 Drug Patent Profile

Which patents cover Flovent Diskus 250, and what generic alternatives are available?

Flovent Diskus 250 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 250 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 250

A generic version of FLOVENT DISKUS 250 was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT DISKUS 250

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	19
Patent Applications:	2,539
DailyMed Link:	FLOVENT DISKUS 250 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 250

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

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

See all FLOVENT DISKUS 250 clinical trials

Pharmacology for FLOVENT DISKUS 250

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 250

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 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 250

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	6,536,427*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	4,335,121*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	6,792,945*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	7,225,808*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	6,378,519*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	5,873,360*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	7,389,775*PED

International Patents for FLOVENT DISKUS 250

See the table below for patents covering FLOVENT DISKUS 250 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H04220266	INHALER
Ireland	862287
Cyprus	2014	Medicament pack
Norway	910836
Austria	A203186
Finland	110991
Greece	910100096

Supplementary Protection Certificates for FLOVENT DISKUS 250

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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117

Market Dynamics and Financial Trajectory for FLOVENT DISKUS 250

Last updated: July 30, 2025

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Introduction

FLOVENT DISKUS 250, an inhaled corticosteroid-based pharmaceutical, is a prominent treatment for asthma and chronic obstructive pulmonary disease (COPD). Its market relevance stems from its efficacy, inhalation delivery system, and position within the respiratory therapeutic landscape. This analysis examines the current market dynamics, competitive landscape, regulatory environment, and financial trajectory influencing FLOVENT DISKUS 250’s positioning and growth potential.

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Market Overview and Therapeutic Landscape

The global respiratory drugs market is valued at approximately USD 45 billion as of 2023, exhibiting a compound annual growth rate (CAGR) of 4.5%. Key drivers include increasing prevalence of respiratory diseases, rising awareness, and advancement in inhalation therapies (1). FLOVENT DISKUS 250, containing fluticasone propionate, faces competition from other inhaled corticosteroids (ICS) and combination therapies, but maintains a strong foothold due to its well-established efficacy and delivery mechanism.

The demand for inhaled steroids remains robust, especially in developed markets such as North America and Europe, driven by high diagnosis rates of asthma and COPD. Emerging markets show potential for growth, fueled by urbanization, air pollution, and increasing healthcare access.

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Market Dynamics

1. Competitive Landscape

FLOVENT DISKUS competes primarily with drugs like Budesonide, Beclomethasone, and combination inhalers containing LABAs. Key competitors include AstraZeneca’s Symbicort and GlaxoSmithKline’s Seretide/Advair. Market dominance is reinforced by brand loyalty, physician prescribing patterns, and product efficacy profiles.

2. Regulatory Environment

Regulatory pathways influence market access and expansion timelines. The FDA and EMA maintain stringent approval processes for respiratory drugs, emphasizing safety profiles and real-world evidence. Recent regulations in some regions aim to promote generic substitution, potentially impacting FLOVENT’s market share unless protected via patent exclusivity.

3. Patent Life and Intellectual Property

FLOVENT DISKUS 250 benefits from a patent expiry slated around 2025-2027, prompting a focus on lifecycle management strategies such as formulation improvements and combination products to sustain revenue streams.

4. Pricing and Reimbursement

Pricing strategies influence revenue, especially amid increasing pressure for cost containment by payers. In the U.S., reimbursement policies favor high-value treatments, which benefits FLOVENT’s premium positioning. Internationally, pricing variability remains a challenge, with regulatory hurdles affecting access in emerging markets.

5. Technological Innovations

Advances in inhaler devices, such as smart inhalers with digital tracking, could redefine market dynamics. Integrating FLOVENT with these innovations may improve adherence and outcomes, thus fostering market retention.

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Financial Trajectory

1. Revenue Trends

Historical sales data indicates steady growth for FLOVENT DISKUS, driven predominantly by mature markets. For instance, in 2022, sales reached approximately USD 1.2 billion globally, reflecting a CAGR of about 3-4% over five years.

Forecasts suggest moderate growth through 2025, contingent on patent protection remaining intact and successful market penetration in emerging regions. The imminent patent expiry may induce revenue erosion unless countered with reformulations or combination therapies.

2. Impact of Patent Expiry

Patent loss in key markets could lead to a significant decline in sales due to generic competition. Historically, generic inhalers enter the market approximately 6-12 months post-patent expiry, often causing a 20-40% drop in revenue over two years (2).

To mitigate this, the manufacturer’s diversification into combination inhalers and new formulations is critical. For example, Fluticasone propionate's integration into fixed-dose combinations with LABAs has demonstrated a potential revenue uplift, cushioning patent expiry impacts.

3. R&D and Pipeline Development

Investment in R&D enhances long-term financial outlook. New delivery systems or enhanced formulations promise increased market share. Pipeline candidates focusing on biologics or novel inhalation devices could open new therapeutic avenues with higher margins.

4. Geographic Expansion

Expanding into Asian markets, particularly China and India, offers substantial growth potential. These markets exhibit rising prevalence rates and increasing willingness to adopt inhalable therapies, promising future revenue streams.

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Challenges and Risk Factors

• Generic Market Entry: Patent expiry exposes FLOVENT to generics, risking steep sales declines.
• Pricing Pressures: Healthcare policy shifts toward biosimilars and generics could compress margins.
• Regulatory Delays: New formulations or device innovations face lengthy approval processes.
• Market Penetration: Achieving market penetration in low-income regions requires strategic pricing and education campaigns.

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Opportunities for Growth

• Lifecycle Management: Developing fixed-dose combination therapies and reformulations.
• Technological Integration: Incorporating digital inhalers and telemedicine for adherence.
• Market Expansion: Focusing on pediatric indications and COPD management programs.
• Partnerships and Collaborations: Licensing agreements with local pharma firms in emerging markets.

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Conclusion

FLOVENT DISKUS 250 offers a resilient revenue base within the inhaled corticosteroid market, supported by its established efficacy and strong regulatory positioning. Yet, imminent patent expiration, competitive pressures, and shifting reimbursement landscapes demand proactive lifecycle management and innovation. With strategic expansion into emerging markets and investment in technological advancements, the long-term financial trajectory can be sustained or even enhanced.

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Key Takeaways

• Market stability stems from FLOVENT’s proven efficacy amid rising prevalence of respiratory diseases.
• Patent expiration (~2025-2027) presents significant revenue risks but can be mitigated through new formulations and combination therapies.
• Competitive landscape requires continuous differentiation via delivery device innovation and digital health integration.
• Emerging markets represent considerable growth opportunities, particularly with local manufacturing and tailored pricing strategies.
• Long-term success hinges on balancing patent protections, innovation, and strategic geographic expansion.

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FAQs

1. When is the patent for FLOVENT DISKUS 250 expected to expire?
The patent expiry is anticipated around 2025-2027, opening the marketplace for generic competitors.

2. How does FLOVENT DISKUS compare to its competitors in efficacy?
Clinical trials have demonstrated comparable efficacy to other ICS inhalers, with a favorable safety profile, maintaining its strong standing among inhaled corticosteroids.

3. What strategies are pharmaceutical companies employing to prolong FLOVENT’s market share post-patent expiry?
Developing combination inhalers, reformulating with enhanced delivery systems, and expanding into emerging markets are primary strategies.

4. What role do technological innovations play in FLOVENT’s future prospects?
Smart inhalers and digital adherence tools improve patient outcomes, creating opportunities for brand differentiation and increased compliance.

5. How are regulatory agencies impacting the future availability of FLOVENT DISKUS 250?
Stringent safety and efficacy standards guide approvals, while evolving policies may influence pricing and market access, especially in cost-sensitive regions.

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References

1. Global Respiratory Drugs Market Report, 2023. MarketsandMarkets.
2. Patent expiry and generic entry analysis, IMS Health, 2022.