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-three 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
Respirent Pharmaceuticals Co 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	4,335,121*PED
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000	7,389,775*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	7,225,808*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
South Korea	850000969
Czech Republic	283168	Inhalační přístroj (INHALATOR)
Ireland	51394	ANDROSTANE CARBOTHIOATES
China	1066036

Supplementary Protection Certificates for FLOVENT DISKUS 250

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117

Market Dynamics and Financial Trajectory for FLOVENT DISKUS 250

Last updated: February 4, 2026

Market Overview

FLOVENT DISKUS 250, a corticosteroid inhaler with the active ingredient fluticasone propionate at a 250 mcg dosage, is used primarily for maintenance therapy in asthma and COPD. Its market position is influenced by the growing prevalence of respiratory diseases globally, with an increasing shift towards long-term inhaled corticosteroids (ICS) as foundational treatments.

Market Size and Growth Drivers

The global inhaled corticosteroids market was valued at approximately USD 7.5 billion in 2020. It is projected to grow at a CAGR of 4-6% through 2027. Rising asthma and COPD prevalence, especially in aging populations and regions with increasing pollution, drives demand for inhaled therapies.

Key growth factors include:

• Rising respiratory disease incidence: The WHO estimates 262 million asthma cases and 251 million COPD cases worldwide in 2019.
• Enhanced awareness: Better diagnosis and management have elevated the use of ICS inhalers like FLOVENT.
• Pharmaceutical pipeline: Ongoing development of combination inhalers and personalized medicine approaches.

Competitive Landscape

Major competitors include:

• Seretide/Advair (fluticasone/salmeterol): Most widely prescribed combination inhaler.
• Breo Ellipta (fluticasone/vilanterol): Popular for its once-daily dosing.
• Symbicort (budesonide/formoterol): Alternative combination with sustained demand.

FLOVENT's market share is challenged but remains significant due to brand loyalty, prescriber preference, and formulary placements, especially in the U.S. and Europe.

Pricing and Reimbursement

Pricing for FLOVENT varies regionally, with U.S. retail prices around USD 250–350 for a 120-dose canister. Reimbursement policies influence prescribing patterns; insurance coverages generally favor established brand providers like FLOVENT due to formulary agreements.

Patent and Regulatory Status

FLOVENT DISKUS 250's patent protection expired in the U.S. in 2013, leading to generic competition. Its exclusivity in key markets has diminished, pushing the brand toward reliance on market share, formulary positioning, and physician loyalty rather than patent protection.

Financial Trajectory

Though exact sales data for FLOVENT DISKUS 250 are proprietary, trends indicate:

• Market saturation: The inhaled corticosteroid segment tends toward maturity with slow overall growth.
• Revenue stability in existing markets: Established markets maintain steady revenues through brand loyalty and chronic therapy adherence.
• Generic erosion: Post-patent expiry, revenue declines unless offset by new formulations or combination products.

Forecasting suggests:

• North American revenues likely decline modestly over the next 3–5 years due to patent expiries and generic competition.
• Emerging markets offer growth opportunities, with CAGR estimates of 5-7% due to increasing respiratory disease burdens and expanding healthcare infrastructure.
• New formulations, such as inclusion in combination inhalers, may augment the product line's lifecycle.

Implications for Investors and R&D

Investors should consider that FLOVENT DISKUS 250's revenue is subject to patent cliffs, competitive pressure, and formulary dynamics. R&D efforts to develop new delivery systems, combination drugs, or biobetters could extend market relevance.

Key Market Risks

• Price pressures from generics and biosimilars.
• Regulatory hurdles in emerging markets.
• Competition from innovative inhaler devices and biologics targeting severe asthma and COPD.

Summary

FLOVENT DISKUS 250 functions within a mature yet still expanding respiratory therapeutics market, driven mainly by disease prevalence rather than innovation. Its future financial trajectory depends on market penetration, formulary access, and pipeline innovation to mitigate patent and generic threats.

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Key Takeaways

• The inhaled corticosteroids market is expanding modestly, with regional variations.
• FLOVENT DISKUS 250 faces patent expiries and generic competition in key markets.
• Revenues are stabilizing in mature markets but remain vulnerable to pricing pressures.
• Growth opportunities exist in emerging markets and through drug combination strategies.
• Innovation and formulary positioning are critical for maintaining market share.

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FAQs

1. What factors influence FLOVENT DISKUS 250’s market share?
Market share depends on prescriber preference, formulary inclusion, competitive pricing, and patient adherence. Brand loyalty remains significant, but generic competition has eroded exclusivity.

2. How has patent expiration impacted FLOVENT DISKUS 250?
Patent expiry in 2013 led to the entry of generic fluticasone inhalers, reducing pricing power and revenue. The brand now relies on clinical efficacy and formulary placement to sustain sales.

3. What are the primary competitors to FLOVENT DISKUS 250?
Advair/Seretide, Breo Ellipta, and Symbicort are the main competitors, offering both monotherapy and combination inhalers with similar active ingredients.

4. What are the growth prospects in emerging markets?
Emerging markets may see 5-7% CAGR driven by increasing respiratory disease prevalence, improving healthcare access, and expanding insurance coverage.

5. What R&D avenues could sustain FLOVENT’s market position?
Developing new delivery devices, creating combination therapies, and integrating digital inhaler technologies can extend product lifecycle and enhance adherence.

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References

1. Research and Markets. "Inhaled Corticosteroids Market Analysis." (2021)
2. World Health Organization. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases." (2019)
3. IQVIA. "Global Respiratory Drugs Market Insights." (2022)
4. U.S. Patent and Trademark Office. "Patent Expiry Dates for FLOVENT." (2013)
5. EvaluatePharma. "Pharmaceutical Sales Forecasts." (2022)

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