FLOVENT DISKUS 50 Drug Patent Profile

Which patents cover Flovent Diskus 50, and what generic alternatives are available?

Flovent Diskus 50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 50 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 50

A generic version of FLOVENT DISKUS 50 was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for FLOVENT DISKUS 50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	19
Patent Applications:	5,456
DailyMed Link:	FLOVENT DISKUS 50 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 50

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 50 clinical trials

Pharmacology for FLOVENT DISKUS 50

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 50

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 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000

International Patents for FLOVENT DISKUS 50

See the table below for patents covering FLOVENT DISKUS 50 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8402317
China	1066036
France	2485542

Supplementary Protection Certificates for FLOVENT DISKUS 50

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 50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flovent Diskus 50

Introduction

Flovent Diskus 50, a medication containing fluticasone propionate, is a widely used inhaled corticosteroid for the treatment of asthma. This article delves into the market dynamics and financial trajectory of Flovent Diskus 50, including its current status, market trends, and the financial implications for its manufacturer, GSK.

Current Status of Flovent Diskus 50

Flovent Diskus 50 is part of the Flovent family of products, which also includes Flovent HFA. These medications are controller therapies used to manage asthma symptoms and prevent exacerbations[1].

Market Discontinuation and Authorized Generics

In a significant move, GSK has announced the discontinuation of the branded versions of Flovent HFA and Flovent Diskus. However, to ensure continued patient access and affordability, GSK has launched an authorized generic for Flovent HFA in May 2022 and plans to launch an authorized generic for Flovent Diskus in October 2023. These authorized generics are expected to provide lower-cost alternatives for patients in the US[1].

Market Size and Growth

The global fluticasone propionate inhalers market, which includes products like Flovent Diskus, was valued at approximately USD 5.6 billion in 2023. This market is projected to grow to USD 8.1 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 4.6% during this period. The growth is driven by increasing incidence of respiratory problems and technological advancements in inhaler devices[3].

Key Market Segments

The fluticasone propionate inhalers market is segmented based on type and application. The types include 60, 120, and 150 metered sprays, while the applications are categorized into use for kids and adults. Understanding these segments is crucial for manufacturers to tailor their products and marketing strategies[3].

Technological Advancements

The inhaler market is witnessing significant technological advancements, including the development of digital inhalers. For instance, Teva Pharmaceuticals has introduced digital inhalers like AirDuo Digihaler and ArmonAir Digihaler, which feature built-in sensors to track usage. Such innovations can impact the market dynamics by offering patients more sophisticated and user-friendly options[5].

Environmental Considerations

Metered dose inhalers (MDIs), including those containing fluticasone propionate, have environmental implications due to the use of hydrofluorocarbons (HFCs) as propellants. Regulatory pressures to reduce HFC emissions may influence the development and adoption of alternative propellants or inhaler types, such as dry powder inhalers (DPIs)[4].

Financial Performance of GSK

GSK's financial performance has been robust, with significant growth in various segments. In 2022, GSK reported a total EPS of 371.4p, up from 109.6p in 2021, largely due to the gain from the demerger of the Consumer Healthcare business and other factors like increased profits and fair value gains on investments. The company's adjusted operating margin was 27.8%, with adjusted operating profit growth of 26% on an annualized basis[2].

Impact of Authorized Generics on Revenue

The launch of authorized generics for Flovent HFA and Flovent Diskus is expected to impact GSK's revenue from these products. While the branded versions will be discontinued, the authorized generics will provide a more affordable option, potentially maintaining patient loyalty and market share. This strategy aligns with GSK's commitment to ensuring the affordability of their medicines[1].

Competitive Landscape

The respiratory medication market is highly competitive, with several players offering a range of products. The introduction of authorized generics and the ongoing development of new technologies and formulations will continue to shape the competitive landscape. Companies like Teva Pharmaceuticals, with their digital inhalers, pose a competitive challenge to traditional inhaler products like Flovent Diskus[5].

Regulatory Environment

Regulatory changes and environmental regulations, such as those related to HFC propellants, can significantly impact the market. Manufacturers must comply with these regulations, which may involve investing in research and development to create more environmentally friendly products[4].

Patient Access and Affordability

Ensuring patient access and affordability is a critical aspect of the market dynamics for Flovent Diskus 50. The launch of authorized generics is a step towards achieving this goal. Additionally, healthcare policies and reimbursement strategies play a crucial role in making these medications accessible to a broader patient population[1].

Future Outlook

The future outlook for Flovent Diskus 50 and similar products is positive, driven by growing demand for respiratory medications and advancements in technology. However, the market will continue to be influenced by regulatory changes, environmental considerations, and competitive pressures.

Key Takeaways

• Market Growth: The global fluticasone propionate inhalers market is expected to grow to USD 8.1 billion by 2032.
• Authorized Generics: GSK is launching authorized generics for Flovent HFA and Flovent Diskus to ensure affordability.
• Technological Advancements: Digital inhalers and alternative propellants are changing the market landscape.
• Regulatory Environment: Compliance with environmental and healthcare regulations is crucial.
• Financial Performance: GSK's financials are strong, with significant growth in various segments.

FAQs

Q: What is the expected market size of fluticasone propionate inhalers by 2032? A: The market is expected to reach USD 8.1 billion by 2032[3].

Q: Why is GSK discontinuing the branded versions of Flovent HFA and Flovent Diskus? A: GSK is discontinuing the branded versions to launch authorized generics, providing patients with potentially lower-cost alternatives[1].

Q: What are the key drivers of the fluticasone propionate inhalers market? A: The key drivers include increasing incidence of respiratory problems and technological advancements[3].

Q: How do environmental regulations impact the inhaler market? A: Environmental regulations, particularly those related to HFC propellants, influence the development and adoption of alternative inhaler types and propellants[4].

Q: What is the significance of digital inhalers in the market? A: Digital inhalers, such as those introduced by Teva Pharmaceuticals, offer advanced features like built-in sensors, enhancing patient compliance and management of respiratory conditions[5].

Sources

1. Asthma and Allergy Foundation of America: Flovent HFA and Flovent Diskus Asthma Medicines Being Discontinued.
2. GSK: Full-year and fourth quarter 2022 results announcement.
3. Business Research Insights: Fluticasone Propionate Inhalers Market Size, Share & Report, 2032.
4. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry.
5. Teva Pharmaceuticals: TEVA REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS.