FLOVENT Drug Patent Profile

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

Flovent is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in four NDAs. There is one patent protecting this drug.

The generic ingredient in FLOVENT 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

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

Summary for FLOVENT

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	38
Patent Applications:	5,455
Drug Prices:	Drug price information for FLOVENT
Drug Sales Revenues:	Drug sales revenues for FLOVENT
What excipients (inactive ingredients) are in FLOVENT?	FLOVENT excipients list
DailyMed Link:	FLOVENT at DailyMed

See drug prices for FLOVENT

See drug sales revenues for FLOVENT

Recent Clinical Trials for FLOVENT

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 clinical trials

US Patents and Regulatory Information for FLOVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-001	Mar 27, 1996		DISCN	No	No
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000		RX	Yes	Yes
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-001	Nov 7, 1997		DISCN	No	No
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes					Y

Expired US Patents for FLOVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-001	Mar 27, 1996
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-003	Nov 7, 1997
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-002	Nov 7, 1997
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-001	Nov 7, 1997

International Patents for FLOVENT

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

Country	Patent Number	Title	Estimated Expiration
Australia	6729881
Hong Kong	58385	ANDROSTANE CARBOTHIOATES
South Africa	8100976
Ecuador	SP941097	CARBOTIOATOS DE ADROSTANO Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN

Supplementary Protection Certificates for FLOVENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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

FLOVENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flovent

Introduction

Flovent, a widely used asthma medication, has been a staple in the treatment of asthma for over two decades. However, recent developments have significantly impacted its market dynamics and financial trajectory.

Market Impact of Discontinuation

Discontinuation of Brand-Name Flovent

As of January 1, 2024, GlaxoSmithKline (GSK) discontinued the production of the brand-name Flovent inhaler, replacing it with authorized generic versions. This decision was influenced by regulatory changes and financial considerations[4].

Increase in Asthma-Related Hospitalizations

The discontinuation of Flovent has led to a notable increase in asthma-related hospitalizations. Data from over 3 million users showed a 17.5% increase in hospitalizations in the three months following the discontinuation, and a 24.1% increase in the subsequent three to six months. ICU admissions also saw a significant rise, highlighting the critical need for effective and accessible asthma treatments[1].

Patient and Healthcare Provider Challenges

The switch to generic alternatives has posed challenges for patients and healthcare providers. Despite the generic versions being functionally identical, issues with affordability, insurance coverage, and ease of use have arisen. For example, the generic version, fluticasone propionate, has been found to be more expensive in some cases, contrary to expectations[1][4].

Financial Considerations

Pricing and Affordability

The brand-name Flovent had seen significant price hikes since 2014, making it vulnerable to cost pressures. The authorized generic version was expected to be cheaper, with a list price of $177.99 for the Flovent HFA inhaler, compared to $337.77 for the brand-name version. However, the actual cost to patients can vary due to discounts, rebates, and insurance adjustments[4].

Impact on GSK's Financial Performance

GSK's decision to discontinue Flovent and switch to generic versions is part of a broader strategy to manage costs and optimize profitability. The company has seen strong growth in other therapeutic areas, such as Specialty Medicines and Vaccines, which has helped offset the impact of discontinuing Flovent. In Q3 2024, GSK reported a strong performance in Specialty Medicines, with sales increasing by 19%, despite a decline in Vaccines sales[5].

Regulatory and Market Factors

FTC Warning and Patent Issues

The discontinuation of Flovent was also influenced by a warning letter from the Federal Trade Commission (FTC) regarding the improper listing of Flovent's patent. This could have delayed the entry of lower-cost generic competitors. Regulatory changes from the American Rescue Plan Act, effective January 1, 2024, provided a financial disincentive for brand-name drug manufacturers, further contributing to GSK's decision[1].

Market Size and Growth

The U.S. asthma drugs market, which includes Flovent and its generic alternatives, is projected to grow significantly. The market size was valued at $8.95 billion in 2023 and is expected to surpass $14.75 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 5.12%. The global asthma drugs market is also anticipated to grow, reaching $40.17 billion by 2033[3].

Consumer and Healthcare Provider Perspectives

Ease of Use and Patient Compliance

Flovent's popularity was partly due to its ease of use, especially for children, who could use it with a spacer device. The generic alternatives, while functionally the same, may require more effort to use, particularly for young children. This change has affected patient compliance and overall health outcomes[1].

Expert Opinions

Dr. Robyn Cohen, a pediatric pulmonologist, highlighted the significance of Flovent in pediatric care and the challenges posed by its discontinuation. "Flovent was by far the most commonly prescribed asthma controller medication for decades," she noted, emphasizing the need for accessible and effective treatments[1].

Key Takeaways

• Discontinuation Impact: The discontinuation of Flovent has led to increased asthma-related hospitalizations and ICU admissions.
• Financial Considerations: The switch to generic versions aims to reduce costs but has introduced affordability and accessibility issues.
• Regulatory Factors: FTC warnings and regulatory changes have influenced GSK's decision to discontinue the brand-name Flovent.
• Market Growth: The U.S. and global asthma drugs markets are expected to grow significantly over the next decade.
• Patient and Provider Challenges: The change has affected patient compliance and ease of use, particularly for children.

FAQs

Q: Why did GSK discontinue the brand-name Flovent?

A: GSK discontinued the brand-name Flovent due to regulatory changes, patent issues, and financial considerations, including a warning from the FTC and the impact of the American Rescue Plan Act[1][4].

Q: What are the consequences of discontinuing Flovent?

A: The discontinuation has led to a significant increase in asthma-related hospitalizations and ICU admissions, as well as challenges in affordability and ease of use for patients[1].

Q: How does the generic version of Flovent compare to the brand-name version?

A: The generic version, fluticasone propionate, is functionally identical to Flovent but has been found to be more expensive in some cases and may require more effort to use, especially for children[1][4].

Q: What is the projected growth of the U.S. asthma drugs market?

A: The U.S. asthma drugs market is expected to grow from $8.95 billion in 2023 to over $14.75 billion by 2033, with a CAGR of 5.12%[3].

Q: How has the discontinuation of Flovent affected GSK's financial performance?

A: Despite the discontinuation of Flovent, GSK has seen strong growth in other therapeutic areas, such as Specialty Medicines, which has helped offset the impact[5].

Sources

1. ABC News: "Discontinuation of popular asthma medication, Flovent, linked to increased hospitalization"[1].
2. GSK Press Release: "Full-year and fourth quarter 2022 results announcement"[2].
3. Biospace: "U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033"[3].
4. USA Today: "Discontinued Flovent inhalers replaced with generics starting Jan. 1"[4].
5. GSK Q3 2024 Results Announcement: "Q3 2024 sales and core earnings growth driven by strong performance of Specialty Medicines"[5].