FLOVENT HFA Drug Patent Profile

Which patents cover Flovent Hfa, and when can generic versions of Flovent Hfa launch?

Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-nine patent family members in seventeen countries.

The generic ingredient in FLOVENT HFA 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 Hfa

A generic version of FLOVENT HFA was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for FLOVENT HFA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	38
Patent Applications:	5,456
Drug Prices:	Drug price information for FLOVENT HFA
Drug Sales Revenues:	Drug sales revenues for FLOVENT HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLOVENT HFA
DailyMed Link:	FLOVENT HFA at DailyMed

See drug prices for FLOVENT HFA

See drug sales revenues for FLOVENT HFA

Recent Clinical Trials for FLOVENT HFA

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

Sponsor	Phase
Glenmark Pharmaceuticals Ltd. India	Phase 3
Children's Hospital Medical Center, Cincinnati	Phase 2
Becro Ltd.	Phase 1

See all FLOVENT HFA clinical trials

Pharmacology for FLOVENT HFA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for FLOVENT HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLOVENT HFA	Inhalation Aerosol	fluticasone propionate	0.22 mg/inh	021433	1	2021-10-29
FLOVENT HFA	Inhalation Aerosol	fluticasone propionate	0.11 mg/inh	021433	1	2016-12-23

US Patents and Regulatory Information for FLOVENT HFA

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 HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004		RX	Yes	Yes
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004		RX	Yes	Yes	7,500,444*PED				Y
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes	7,500,444*PED				Y

Expired US Patents for FLOVENT HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,161,724*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004	6,161,724*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	5,674,472*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,170,717*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,431,168*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	6,510,969*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	7,107,986*PED

International Patents for FLOVENT HFA

See the table below for patents covering FLOVENT HFA around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	988	Valve for Aerosol container.
Australia	718576
Australia	5390196
South Korea	20000069749
Australia	755977
Peru	6399	VALVULA PARA RECIPIENTE DE AEROSOL
Hungary	9802278

Supplementary Protection Certificates for FLOVENT HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

FLOVENT HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: FLOVENT HFA

Introduction

FLOVENT HFA, a widely used inhaler for managing asthma, has been a cornerstone in respiratory care for many years. However, recent developments have significantly impacted its market dynamics and financial trajectory.

Discontinuation of Brand-Name FLOVENT HFA

In 2024, GlaxoSmithKline (GSK) announced the discontinuation of the brand-name version of FLOVENT HFA. This decision was influenced by several factors, including regulatory changes and financial considerations.

Regulatory Changes

The American Rescue Plan Act, effective from January 1, 2024, introduced regulatory changes that provided a financial disincentive for brand-name drug manufacturers. Additionally, the Federal Trade Commission (FTC) issued a warning letter to GSK and other drug manufacturers, alleging that the patent for FLOVENT was "improperly or inaccurately listed," which could delay the entry of lower-cost generic alternatives[1].

Financial Considerations

The discontinuation of the brand-name FLOVENT HFA was also driven by financial factors. GSK shifted focus to manufacturing an authorized generic version of the medication, fluticasone propionate. Despite the expectation that generic medications would be more cost-effective, the authorized generic version of FLOVENT HFA has been found to be more expensive than the previous brand-name version in some cases[1].

Impact on Patients and Healthcare System

The discontinuation of FLOVENT HFA has had significant implications for patients and the healthcare system.

Increased Hospitalizations

Data from over 3 million people who had been using FLOVENT HFA showed a 17.5% increase in asthma-related hospitalizations in the three months after the medication was discontinued. This increase rose to 24.1% in the following three to six months. ICU admissions for asthma also saw a 17.4% increase during this period[1].

Patient Experiences

Patients like Burton Hayes, who had been successfully managing their asthma with FLOVENT HFA, experienced a deterioration in their condition after switching to the generic alternative. This highlights the challenges patients face when their established treatment regimens are disrupted[1].

Market Size and Growth

Despite the discontinuation of the brand-name FLOVENT HFA, the market for fluticasone propionate inhalers remains robust.

Global Market Size

The global fluticasone propionate inhalers market was valued at approximately USD 5.6 billion in 2023 and is expected to reach USD 8.1 billion by 2032. This growth is driven by increasing incidence of respiratory problems and technological advancements in the field[3].

Market Segmentation

The market is segmented based on type (60 metered sprays, 120 metered sprays, 150 metered sprays) and application (kids, adults). This segmentation indicates a diverse market catering to different patient needs[3].

Financial Performance of GSK

GSK's financial performance has been influenced by the discontinuation of FLOVENT HFA and the transition to its authorized generic version.

Revenue and Profit

In 2022, GSK reported strong financial performance, with total continuing operating profit increasing significantly due to fair value gains on investments and milestone income from disposals. However, the transition to generic versions of medications like FLOVENT HFA has introduced new financial dynamics, including potential impacts on revenue and profit margins[2].

Adjusted Operating Profit

GSK's adjusted operating profit for 2023 showed a growth of 8% at actual exchange rates (AER) and 12% at constant exchange rates (CER), partly offset by increased investment in research and development and new product launches[5].

Environmental Considerations

The production and use of inhalers like FLOVENT HFA also have environmental implications.

HFC Propellants

Inhalers containing hydrofluorocarbons (HFCs) such as HFC-134a and HFC-227ea contribute to greenhouse gas emissions. The U.S. market for these inhalers is significant, with approximately 1,284 metric tons of HFC-134a and 207 metric tons of HFC-227ea sold in 2020. Efforts are underway to explore alternative propellants to reduce environmental impact[4].

Key Takeaways

• Discontinuation Impact: The discontinuation of FLOVENT HFA has led to increased hospitalizations and challenges for patients.
• Market Growth: The global fluticasone propionate inhalers market is expected to grow to USD 8.1 billion by 2032.
• Financial Dynamics: GSK's financial performance has been influenced by the transition to generic versions and regulatory changes.
• Environmental Concerns: The use of HFC propellants in inhalers raises environmental concerns, prompting research into alternative propellants.

FAQs

What led to the discontinuation of FLOVENT HFA?

The discontinuation was driven by regulatory changes from the American Rescue Plan Act and a warning letter from the FTC regarding the patent listing, along with financial considerations.

How has the discontinuation of FLOVENT HFA affected patients?

Patients have experienced increased asthma-related hospitalizations and ICU admissions, and some have reported a deterioration in their condition after switching to the generic alternative.

What is the expected growth of the fluticasone propionate inhalers market?

The market is expected to reach USD 8.1 billion by 2032, growing at a CAGR of 4.6%.

What are the key segments of the fluticasone propionate inhalers market?

The market is segmented based on type (metered sprays) and application (kids, adults).

How does the use of HFC propellants in inhalers impact the environment?

The use of HFC propellants contributes to greenhouse gas emissions, with approximately 1,491 metric tons of HFCs sold in the U.S. in 2020, prompting research into alternative propellants.

Sources

1. ABC News: Discontinuation of popular asthma medication, Flovent linked to increased hospitalization[1].
2. GSK: Full-year and fourth quarter 2022 results announcement[2].
3. Business Research Insights: Fluticasone Propionate Inhalers Market Size, Share & Report, 2032[3].
4. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry[4].
5. GSK: Q4 2023 Announcement[5].