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 FOUGERA PHARMS on May 14^th, 2004.

Summary for FLOVENT DISKUS 250

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	19
Patent Applications:	5,455
DailyMed Link:	FLOVENT DISKUS 250 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 250

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

Sponsor	Phase
Respirent Pharmaceuticals Co Ltd.	Phase 1
Becro 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	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	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
Spain	8402317
China	1066036
France	2485542

Supplementary Protection Certificates for FLOVENT DISKUS 250

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

FLOVENT DISKUS 250 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flovent Diskus 250

Introduction

Flovent Diskus, a widely used inhaled corticosteroid medication for treating asthma, has been a staple in the pharmaceutical market since its introduction in 2000. However, recent changes in the market, regulatory environment, and generic competition are significantly impacting its market dynamics and financial trajectory.

Historical Context and Market Presence

Flovent Diskus, developed by GlaxoSmithKline (GSK), has been a dominant player in the asthma treatment market. It was introduced as a maintenance treatment for asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older[4].

Sales and Revenue

Historically, Flovent Diskus has generated substantial revenue for GSK. For instance, the total U.S. sales of similar respiratory products, such as Advair Diskus, were approximately $3 billion for the 12 months ending April 2021, indicating the significant market value of these medications[5].

Transition to Authorized Generics

In a strategic move to maintain market presence and profitability, GSK introduced authorized generics of Flovent HFA and Flovent Diskus. The authorized generic of Flovent HFA was launched in May 2022, and the authorized generic of Flovent Diskus was launched in October 2023. Effective January 1, 2024, GSK discontinued manufacturing the branded versions of these products in the U.S. market[3][4].

Impact on Pricing and Affordability

The transition to authorized generics is expected to provide patients with potentially lower-cost alternatives. For example, the wholesale acquisition cost of the authorized generic version of Flovent HFA is significantly lower than the branded version, with a price difference of about 50%[3].

Regulatory Changes and Medicaid Rebates

A significant regulatory change affecting the pricing strategy of Flovent Diskus is the removal of the cap on Medicaid rebates. Previously, rebates were capped at the total price of the drug, but the new policy eliminates this cap. This change prompted GSK to switch to authorized generics to avoid large penalties due to price increases over the years[3].

Competitive Landscape

The introduction of generic versions of respiratory medications is altering the competitive landscape. For instance, Lannett Company, Inc. has received FDA acceptance for its Abbreviated New Drug Application (ANDA) for a generic version of Advair Diskus, a product similar to Flovent Diskus. This generic competition is expected to further reduce prices and impact the market share of branded products[5].

Market Projections and Growth

Despite the transition to generics, the demand for asthma medications is expected to continue growing. The population with asthma and COPD has been growing at an average annual rate of about 1.3%, which supports the ongoing need for these medications. However, the growth in sales of HFC-based inhalers, such as those used in Flovent Diskus, is projected to be moderate due to potential transitions to alternative propellants like HFC-152a in the future[1].

Financial Implications

The financial trajectory of Flovent Diskus is likely to be impacted by the transition to authorized generics and the introduction of generic competitors. While the authorized generics may maintain some market share and profitability, the overall revenue from Flovent Diskus is expected to decline as generic versions become more prevalent. The removal of the Medicaid rebate cap and the associated penalties also influence GSK's pricing and revenue strategies[3][5].

Patient Impact and Supply Chain

The transition from branded to authorized generics is expected to have minimal disruption for patients. The authorized generics contain the same medicine, in the same familiar device, and with the same instructions for use as the branded versions. This ensures continuity in treatment without significant changes for patients[4].

Industry Expert Insights

Industry experts view the transition to authorized generics as a strategic move to maximize profitability. David Amsellem, a financial analyst at Piper Sandler, noted that this strategy helps companies avoid large rebates to Medicaid and maintain market presence despite regulatory changes[3].

Environmental Considerations

The use of HFC propellants in inhalers like Flovent Diskus has environmental implications due to their high global warming potential. The EPA has been monitoring HFC consumption, and there is a potential shift towards alternative propellants in the future, which could further impact the market dynamics of these products[1].

Key Takeaways

• Transition to Authorized Generics: GSK has introduced authorized generics of Flovent Diskus to maintain market presence and profitability.
• Pricing and Affordability: Authorized generics offer lower-cost alternatives, reducing the financial burden on patients.
• Regulatory Changes: The removal of the Medicaid rebate cap has significant implications for pricing strategies.
• Competitive Landscape: Generic competition is increasing, impacting the market share of branded products.
• Market Projections: Demand for asthma medications continues to grow, but sales of HFC-based inhalers may be moderate due to potential transitions to alternative propellants.
• Financial Implications: Revenue from Flovent Diskus is expected to decline with the introduction of generic competitors and regulatory changes.

FAQs

What is the difference between Flovent Diskus and its authorized generic?

The authorized generic of Flovent Diskus contains the same medicine, in the same device, and with the same instructions for use as the branded version but is priced lower.

Why is GSK discontinuing the branded version of Flovent Diskus?

GSK is discontinuing the branded version to avoid large penalties due to price increases under the new Medicaid rebate policy and to maintain profitability through authorized generics.

How will the transition to authorized generics affect patients?

The transition is expected to have minimal disruption for patients, as the authorized generics are identical to the branded versions in terms of medicine, device, and instructions.

What are the environmental implications of HFC propellants in inhalers like Flovent Diskus?

HFC propellants have a high global warming potential, and there is a potential shift towards alternative propellants in the future to reduce environmental impact.

How does the competitive landscape affect the market dynamics of Flovent Diskus?

The introduction of generic versions of respiratory medications increases competition, reducing prices and impacting the market share of branded products like Flovent Diskus.

Sources

1. Market Characterization of the U.S. Metered Dose Inhaler Industry - Prepared by ICF International for the U.S. Environmental Protection Agency (EPA)[1].
2. Cost-effectiveness of combination fluticasone propionate–salmeterol - PMC[2].
3. Asthma inhaler Flovent to be replaced by generic version in January - CBS News[3].
4. Flovent HFA and Flovent Diskus Asthma Medicines Being Discontinued - Asthma and Allergy Foundation of America[4].
5. Lannett Announces FDA Acceptance, As A Priority Original ANDA Of The Generic Advair Diskus Filing - BioSpace[5].