FLOVENT DISKUS 100 Drug Patent Profile

When do Flovent Diskus 100 patents expire, and what generic alternatives are available?

Flovent Diskus 100 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in FLOVENT DISKUS 100 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 100

A generic version of FLOVENT DISKUS 100 was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for FLOVENT DISKUS 100

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 100 at DailyMed

Recent Clinical Trials for FLOVENT DISKUS 100

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

Sponsor	Phase
Respirent Pharmaceuticals Co Ltd.	Phase 1
Becro Ltd.	Phase 1
Becro Ltd.	Phase 3

See all FLOVENT DISKUS 100 clinical trials

Pharmacology for FLOVENT DISKUS 100

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for FLOVENT DISKUS 100

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 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000		RX	Yes	Yes

Expired US Patents for FLOVENT DISKUS 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000

International Patents for FLOVENT DISKUS 100

See the table below for patents covering FLOVENT DISKUS 100 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8402317
China	1066036
France	2485542
Netherlands	193930
Bulgaria	60700
United Kingdom	2088877	ANDROSTANE 17 CARBOTHIOATES

Supplementary Protection Certificates for FLOVENT DISKUS 100

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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

FLOVENT DISKUS 100 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flovent Diskus 100

Introduction

Flovent Diskus, a widely used inhaled corticosteroid, has been a cornerstone in the treatment of asthma for over two decades. However, recent changes in the market dynamics, particularly the introduction of authorized generic versions, have significantly impacted the drug's financial trajectory.

Discontinuation of Branded Flovent Diskus

As of January 1, 2024, GlaxoSmithKline (GSK) has discontinued the manufacturing of branded Flovent Diskus (all strengths) for the U.S. market. This decision follows the launch of authorized generic versions of Flovent Diskus in October 2023, which are designed to provide patients with a potentially lower-cost alternative[1][4].

Authorized Generic Versions

The authorized generic versions of Flovent Diskus contain the same active ingredient, fluticasone propionate, in the same device and with the same instructions for use as the branded version. This transition is intended to ensure minimal disruption for patients while offering a more affordable option. The authorized generic of Flovent HFA, for example, is priced at $177.99, significantly lower than the branded version's price of $264.26 for the 100mcg dosage[4].

Market Impact

The discontinuation of the branded Flovent Diskus and the introduction of its generic counterparts are expected to have several market implications:

Affordability

One of the primary drivers behind this change is affordability. The authorized generic versions are likely to be more cost-effective for patients, especially those with insurance coverage that favors generic medications. However, the actual cost savings will depend on individual insurance plans and benefit designs[1][4].

Market Size and Growth

The global fluticasone propionate inhalers market, which includes Flovent Diskus, is projected to grow significantly. By 2032, the market is expected to reach USD 8.1 billion, up from approximately USD 5.6 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 4.6%. This growth is driven by increasing incidence of respiratory problems and technological advancements in inhaler technology[3].

Competition

The introduction of authorized generics increases competition in the market, which can lead to better pricing and more options for patients. However, it also poses challenges for GSK in terms of maintaining market share and revenue from these products.

Financial Trajectory

Revenue Impact

The transition from branded to authorized generic versions is expected to impact GSK's revenue from Flovent Diskus. While the company aims to maintain supply and minimize disruption, the shift to generics typically results in lower revenue per unit sold. However, GSK's overall financial performance is diversified across various product lines, including vaccines, oncology, and other specialty areas, which helps mitigate the impact[2][5].

Cost Savings

GSK anticipates cost savings from the discontinuation of branded products. The reduction in manufacturing and marketing costs for branded Flovent Diskus can be redirected to other areas, such as research and development or the promotion of other products.

Investor Perspective

From an investor perspective, GSK's decision reflects a strategic move to prioritize profitability and patient affordability. The company's financial reports indicate strong growth in operating profit and earnings per share, partly due to the successful launch of new products and the optimization of existing ones. The discontinuation of branded Flovent Diskus and the launch of authorized generics align with GSK's commitment to affordability and patient access[2][5].

Patient and Healthcare Provider Impact

Availability and Access

Patients and healthcare providers can expect minimal disruption in the availability of Flovent Diskus, as the authorized generic versions are designed to be functionally equivalent to the branded products. However, there may be initial adjustments as patients and providers adapt to the new packaging and labeling[1][4].

Insurance Coverage

The affordability of the authorized generic versions will depend on insurance coverage. Patients may need to check with their insurance providers to understand the extent of coverage and any potential changes in copays or out-of-pocket costs[4].

Technological and Regulatory Environment

Technological Advancements

The fluticasone propionate inhalers market is driven by technological advancements, which improve the efficacy and user experience of inhalers. These advancements are expected to continue, offering better treatment options for patients with respiratory conditions[3].

Regulatory Considerations

Regulatory environments play a crucial role in the pharmaceutical industry. The approval and regulation of generic versions ensure that these products meet the same safety and efficacy standards as their branded counterparts. GSK's decision to launch authorized generics is in line with regulatory requirements and industry standards[1].

Key Takeaways

• Discontinuation of Branded Flovent Diskus: As of January 1, 2024, GSK has stopped manufacturing branded Flovent Diskus in the U.S. market.
• Authorized Generic Versions: Authorized generics of Flovent Diskus are now available, offering a potentially lower-cost alternative.
• Market Growth: The global fluticasone propionate inhalers market is expected to grow to USD 8.1 billion by 2032.
• Financial Impact: The transition is expected to impact GSK's revenue but will also result in cost savings.
• Patient and Provider Impact: Minimal disruption is expected, but patients should check their insurance coverage.

FAQs

What is the reason behind GSK discontinuing the branded Flovent Diskus?

GSK has discontinued the branded Flovent Diskus to introduce authorized generic versions, which are expected to be more affordable for patients.

How will the authorized generic versions of Flovent Diskus affect patients?

The authorized generic versions will provide patients with a potentially lower-cost alternative that is functionally equivalent to the branded product.

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

The global fluticasone propionate inhalers market is expected to reach USD 8.1 billion by 2032, with a CAGR of 4.6%.

How will the discontinuation of branded Flovent Diskus impact GSK's revenue?

The transition to authorized generics is expected to reduce revenue per unit sold, but GSK's diversified product portfolio will help mitigate this impact.

What are the key factors driving the growth of the fluticasone propionate inhalers market?

Increasing incidence of respiratory problems and technological advancements in inhaler technology are the primary drivers of market growth.

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. USA Today: "Discontinued Flovent inhalers replaced with generics starting Jan. 1"
5. GSK: "Investor Information - 2023 Annual Report"