fluticasone furoate - Profile

What are the generic sources for fluticasone furoate and what is the scope of freedom to operate?

Fluticasone furoate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Haleon Us Holdings, and Glaxo Grp Ltd, and is included in four NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate has one hundred and twenty patent family members in twenty-three countries.

Summary for fluticasone furoate

International Patents:	120
US Patents:	11
Tradenames:	4
Applicants:	3
NDAs:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone furoate

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

Dosage:

SPRAY, METERED;NASAL

^*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.

Paragraph IV (Patent) Challenges for FLUTICASONE FUROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLONASE SENSIMIST ALLERGY RELIEF	Nasal Spray	fluticasone furoate	27.5 mcg	022051	1	2011-07-15

US Patents and Regulatory Information for fluticasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y

Expired US Patents for fluticasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014

EU/EMA Drug Approvals for fluticasone furoate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Avamys	fluticasone furoate	EMEA/H/C/000770Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.	Authorised	no	no	no	2008-01-11
Glaxo Group Ltd.	Alisade	fluticasone furoate	EMEA/H/C/001019Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.	Withdrawn	no	no	no	2008-10-06

International Patents for fluticasone furoate

Country	Patent Number	Title	Estimated Expiration
Norway	20044495
Australia	2003253367	A FLUID DISPENSING DEVICE
European Patent Office	1868731	DISPOSITIF DE DISTRIBUTION DE FLUIDE (A FLUID DISPENSING DEVICE)
Australia	2003224153	A FLUID DISPENSING DEVICE
China	101723143	Fluid dispensing device
European Patent Office	1501576	DISPOSITIF DE DISTRIBUTION DE FLUIDE (A FLUID DISPENSING DEVICE)

Supplementary Protection Certificates for fluticasone furoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Fluticasone Furoate Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What Is Fluticasone Furoate?

Fluticasone furoate (FF) is a synthetic corticosteroid used primarily in the treatment of allergic rhinitis, asthma, and related respiratory conditions. It is a potent anti-inflammatory agent administered via inhalers and nasal sprays. Marketed under brand names such as Relovair, Arnuity Ellipta, and others, FF has a patent expiry timeline and competitive landscape that influence investment potential.

Market Position and Revenue Drivers

• Global Market Size: The inhaled corticosteroids (ICS) market reached approximately $8.2 billion in 2022 with a compound annual growth rate (CAGR) of 4.5% (Grand View Research, 2022).
• Key Indications: Asthma and allergic rhinitis. FF’s unique potency and dosing frequency provide competitive advantages in these segments.
• Major Brands: GSK’s Arnuity Ellipta dominates the nasal inhaler market, with revenues exceeding $1 billion in 2022 (GSK Annual Report, 2022).

Patent and Regulatory Status

• Patent Duration: Patent expiry is expected between 2025 and 2028, depending on jurisdiction. GSK filed for additional patents and formulations extending exclusivity periods.
• Regulatory Approvals: Approved in the U.S., Europe, and Japan. Regulatory status subject to local drug approval processes, with potential for biosimilar or generic competition post-expiry.
• Pipeline Developments: GSK continues to explore combination regimens and new delivery mechanisms to extend commercial viability.

Competitive Landscape and Market Dynamics

Competitor	Product	Market Share (2022)	Patent Status	Key Differentiator
GSK	Arnuity Ellipta	70%	Patent protected until 2026	Less frequent dosing, high potency
Teva	Fluticasone propionate nasal spray	15%	Generic, post-patent	Lower price point
Mylan	Multiple generic FF formulations	10%	Pending biosimilars	Cost competitiveness

Financials and Investment Considerations

Revenue Trends

• GSK’s respiratory division reported $4.2 billion in inhaled corticosteroids revenue in 2022.
• FF-specific sales accounted for approximately 20%-25% of this segment.

Cost Structure

• Production costs primarily involve API synthesis and inhaler device manufacturing.
• R&D investments focus on formulation improvements and new indication approvals.

Brand Strategy and Market Penetration

• GSK invests in physician education and direct-to-consumer advertising.
• Expansion into emerging markets presents growth opportunities, though price sensitivity remains a concern.

Risks and Challenges

• Patent Cliff: Approaching patent expiry increases exposure to generics, potentially eroding market share.
• Competitive Substitutes: Developments in biologics and alternative therapies for asthma could reduce reliance on ICS.
• Regulatory Risks: Post-market safety issues or new regulations could impact sales.
• Pricing Pressure: Reimbursement policies and cost-cutting initiatives pressurize margins.

Investment Outlook

• Short-term (1-3 years): Stable revenue from existing patents, with potential growth from market expansion.
• Mid to Long-term (4-8 years): Revenue risks increase as patent expiry approaches; success depends on pipeline assets and market share retention.

Key Takeaways

• Fluticasone furoate remains a high-margin product for GSK, with a dominant market position until 2026.
• Patent expiration and generic competition pose a significant risk beyond 2025.
• Growth hinges on expanding indications, geographic markets, and pipeline development.
• Competitive landscape is mature, with several generic entrants prepared to capitalize on patent cliffs.
• Cost control, marketing, and pipeline progress are critical factors influencing investment returns.

FAQs

Q1: What is the remaining patent life for fluticasone furoate?
A1: Patents are expected to expire between 2025 and 2028, varying by jurisdiction.

Q2: How vulnerable is the product to generic competition?
A2: Highly vulnerable post-patent expiry, with multiple generics and biosimilars entering the market.

Q3: What are the primary growth prospects for FF?
A3: Expansion into emerging markets, new formulations, and potential new indications.

Q4: What regulatory risks exist for FF?
A4: Safety concerns, label updates, or new regulatory restrictions could impact sales.

Q5: How does FF compare to other corticosteroids in efficacy?
A5: It is considered more potent and has a longer dosing interval, offering clinical advantages over some competitors.

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References:

[1] Grand View Research. (2022). Inhaled Corticosteroids Market Size, Share & Trends Analysis.
[2] GSK Annual Report. (2022). GSK Plc.
[3] U.S. Food and Drug Administration. (2022). Approved Drugs Database.