FLONASE Drug Patent Profile

When do Flonase patents expire, and when can generic versions of Flonase launch?

Flonase is a drug marketed by Haleon Us Holdings and is included in three NDAs. There are four patents protecting this drug.

The generic ingredient in FLONASE is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Flonase

Indicators of Generic Entry

Summary for FLONASE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	24
Patent Applications:	5,455
Drug Prices:	Drug price information for FLONASE
Drug Sales Revenues:	Drug sales revenues for FLONASE
What excipients (inactive ingredients) are in FLONASE?	FLONASE excipients list
DailyMed Link:	FLONASE at DailyMed

See drug prices for FLONASE

See drug sales revenues for FLONASE

Recent Clinical Trials for FLONASE

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
University of South Florida	Phase 3
St. Paul's Sinus Centre	Phase 4

See all FLONASE clinical trials

US Patents and Regulatory Information for FLONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994		DISCN	Yes	No
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 ALLERGY RELIEF	fluticasone propionate	SPRAY, METERED;NASAL	205434-001	Jul 23, 2014		OTC	Yes	No
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 FLONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994

International Patents for FLONASE

See the table below for patents covering FLONASE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	A67481
Denmark	147022
Italy	1170717	CARBOTIOATI ANDROSTANICI PROCEDIMENTO PER PREPARARLI E COMPOSIZIONI FARMACEUTICHE CHE LI CONTENGONO
Japan	S56138200	ANDROSTANE CARBOTHIOATE COMPOUND
Netherlands	191792
Canada	1205464	CARBOTHIOATES D'ANDROSTANE (ANDROSTANE CARBOTHIOATES)
Spain	8502447

Supplementary Protection Certificates for FLONASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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	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	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND 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

FLONASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of FLONASE

Introduction to FLONASE

FLONASE, a brand name for fluticasone propionate, is a widely used nasal spray for the treatment of allergic rhinitis and other respiratory conditions. It is a corticosteroid that reduces inflammation and congestion in the nasal passages.

Global Nasal Spray Market Overview

The global nasal spray market, which includes products like FLONASE, has been experiencing significant growth. In 2022, the market size was valued at $25.30 billion and is projected to reach $49.54 billion by 2030, growing at a CAGR of 8.8% from 2023 to 2030[1].

Market Segmentation and FLONASE's Position

Product Type

The corticosteroids segment, which includes FLONASE, led the market by product type in 2022. This segment is driven by the increasing incidence of allergic conditions and respiratory infections[1].

Distribution Channels

The market is segmented into drug stores & retail pharmacies, hospital pharmacies, and online pharmacies. The drug stores & retail pharmacies segment has seen significant growth due to the increasing number of retail pharmacies and the convenience they offer[1].

Regional Market Performance

North America

North America held the largest market share in 2022, with the U.S. being a major contributor. FLONASE, being a popular brand in this region, benefits from the high adoption rates of nasal sprays for treating common allergies and respiratory issues[1][4].

Europe and Asia Pacific

Europe accounted for the second-highest market share in 2022, driven by the higher adoption of nasal sprays for treating the common cold and other allergies. The Asia Pacific region is expected to be the fastest-growing market during the forecast period, driven by strategic partnerships and improving healthcare infrastructure[1].

Drivers of Market Growth

Increasing Funding for R&D

Private organizations are increasingly funding research and development activities for new medicines, including nasal sprays. This funding boosts the development and approval of new products, contributing to market growth[1].

Growing Demand for Generic and OTC Products

The demand for generic and over-the-counter (OTC) nasal sprays is rising due to their relatively lower costs and increasing availability. FLONASE, available in both prescription and OTC forms, benefits from this trend[1][3].

Rising Incidence of Respiratory Diseases

The growing incidence of acute and chronic respiratory diseases, particularly among the geriatric population, is a significant driver of the market. FLONASE, with its efficacy in treating allergic rhinitis, is well-positioned to capitalize on this trend[3].

Financial Performance of Key Players

GlaxoSmithKline (GSK)

GSK, the manufacturer of FLONASE, is one of the major players in the global nasal spray market. While specific financial data for FLONASE is not always disclosed separately, the overall performance of GSK's respiratory segment is indicative of the market's health.

Competitive Landscape

The nasal spray market is highly competitive, with major players including Johnson & Johnson, Bayer AG, GSK, and Viatris, Inc. These companies are constantly engaged in the development and approval of new products, which drives market competition and innovation[1].

Technological Advances and Innovations

Technological advances in inhalation and nasal spray devices are enhancing the efficacy and user experience of products like FLONASE. These innovations include better delivery systems and formulations that improve patient compliance and treatment outcomes[3].

Challenges and Restraints

Despite the growth, the market faces challenges such as regulatory hurdles and the need for continuous innovation to stay competitive. Additionally, the rise of generic alternatives can impact the sales of branded products like FLONASE[4].

Key Takeaways

• The global nasal spray market is projected to grow significantly, driven by increasing funding for R&D, growing demand for generic and OTC products, and the rising incidence of respiratory diseases.
• FLONASE, as a leading corticosteroid nasal spray, benefits from these trends and is well-positioned in the market.
• North America and Europe are key regions for FLONASE, with the Asia Pacific region expected to show rapid growth.
• Technological advances and innovations are crucial for maintaining market competitiveness.

FAQs

1. What is the projected growth rate of the global nasal spray market? The global nasal spray market is expected to grow at a CAGR of 8.8% from 2023 to 2030[1].

2. Which segment led the nasal spray market by product type in 2022? The corticosteroids segment, which includes FLONASE, led the market by product type in 2022[1].

3. What are the key drivers of the nasal spray market growth? Key drivers include increasing funding for R&D, growing demand for generic and OTC products, and the rising incidence of respiratory diseases[1][3].

4. Which region is expected to be the fastest-growing market for nasal sprays? The Asia Pacific region is expected to be the fastest-growing market during the forecast period[1].

5. Who are the major players in the global nasal spray market? Major players include Johnson & Johnson, Bayer AG, GSK, and Viatris, Inc.[1].

Sources:

1. Fortune Business Insights - Nasal Spray Market Size, Growth | Trends Analysis [2030].
2. Optinose - Optinose Reports First Quarter 2023 Financial Results and ....
3. Emergen Research via Biospace - Inhalation and Nasal Spray Market Size to Reach USD 46.79 Billion ....
4. Transparency Market Research - Nasal Corticosteroids Market Size, Share & Trends Report, 2034.
5. ARS Pharmaceuticals - ARS Pharmaceuticals Reports Third Quarter 2024 Financial Results ....