Fluticasone propionate - Generic Drug Details

What are the generic drug sources for fluticasone propionate and what is the scope of patent protection?

Fluticasone propionate is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Cosette, Encube, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Taro Pharm Inds, Teva Pharm, Haleon Us Holdings, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-seven NDAs. There are forty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has eight hundred and two patent family members in forty countries.

There are twenty-four drug master file entries for fluticasone propionate. Seventy-two suppliers are listed for this compound.

Summary for fluticasone propionate

International Patents:	802
US Patents:	47
Tradenames:	20
Applicants:	20
NDAs:	37
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	72
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	365
Patent Applications:	8,159
Drug Prices:	Drug price trends for fluticasone propionate
Drug Sales Revenues:	Drug sales revenues for fluticasone propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone propionate
What excipients (inactive ingredients) are in fluticasone propionate?	fluticasone propionate excipients list
DailyMed Link:	fluticasone propionate at DailyMed

See drug prices for fluticasone propionate

See drug sales revenues for fluticasone propionate

Recent Clinical Trials for fluticasone propionate

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Humanis Saglık Anonim Sirketi	Phase 1
Emory University	Phase 3

See all fluticasone propionate clinical trials

Pharmacology for fluticasone propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone propionate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE

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
CUTIVATE	Lotion	fluticasone propionate	0.05%	021152	1	2008-07-28

US Patents and Regulatory Information for fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020		DISCN	Yes	No	11,357,935*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		DISCN	Yes	No	10,561,808*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		DISCN	Yes	No	10,765,820*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No	10,022,510*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No	10,124,131*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes	11,969,544*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No	10,765,820*PED				Y

Expired US Patents for fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020	6,701,917
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	7,832,351*PED
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000	7,225,808*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,510,969*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,743,413*PED
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,327,844
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000	6,378,519*PED

International Patents for fluticasone propionate

Country	Patent Number	Title	Estimated Expiration
Mexico	2017002552	MODULO DE MONITOREO DE CUMPLIMIENTO PARA UN INHALADOR ACCIONADO POR RESPIRACION. (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER.)
Poland	206318
Spain	2544278
Spain	2529229
Slovenia	1667627
Slovenia	1699434
Eurasian Patent Organization	201300235	ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННОГО ВЕЩЕСТВА

Supplementary Protection Certificates for fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
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
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

Fluticasone propionate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluticasone Propionate

Market Overview

Fluticasone propionate, a widely used glucocorticoid, is a key player in the treatment of various respiratory and dermatological conditions. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global fluticasone propionate inhalers market is projected to experience significant growth. As of 2023, the market size was valued at approximately USD 5.6 billion and is expected to reach USD 8.1 billion by 2032, growing at a CAGR of about 4.6% during the forecast period[1].

Key Market Segments

The fluticasone propionate market is segmented based on several criteria:

• By Type: The market is classified into 60 metered sprays, 120 metered sprays, and 150 metered sprays. These different formulations cater to various patient needs and treatment durations[1][4].
• By Application: The market is segmented into two main application categories: kids and adults. This segmentation helps in tailoring the treatment to the specific age group and their respective health needs[1][4].

Driving Factors

Several factors are driving the growth of the fluticasone propionate market:

• Increasing Incidence of Respiratory Problems: The rising prevalence of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) is a significant driver. As more people are diagnosed with these conditions, the demand for effective treatments like fluticasone propionate increases[1].
• Technological Advancements: Advances in medical technology, including the development of more efficient inhaler devices and novel drug delivery systems, are enhancing the efficacy and convenience of fluticasone propionate treatments. For example, the Exhalation Delivery System (EDS) used in products like XHANCE improves the delivery of the medication deep into the nasal passages[3].

Cost-Effectiveness

Fluticasone propionate has been shown to be more cost-effective compared to other inhaled corticosteroids like budesonide. A pharmacoeconomic analysis revealed that treatment with fluticasone propionate was cheaper, with weekly costs of 7.78 Pounds compared to 12.33 Pounds for budesonide. The lower costs are attributed to reduced healthcare contacts and better efficacy in improving symptoms and reducing episodes of respiratory distress[2].

Geographical Insights

The market for fluticasone propionate is spread across various geographical regions:

• North America: This region is expected to dominate the market due to a large consumer base and high healthcare expenditure. The presence of advanced healthcare infrastructure and increased awareness about respiratory conditions also contribute to the market growth in this region[3][4].
• Europe, Asia-Pacific, and Other Regions: These regions also show significant growth potential, driven by increasing healthcare spending, rising awareness, and technological advancements[4].

Competitive Landscape

The fluticasone propionate market is competitive, with several key players:

• GSK, Teva, West-ward Pharmaceuticals, Apotex Corp., Akorn, Wockhardt: These companies are actively involved in the development, manufacturing, and marketing of fluticasone propionate products. Their investments in research and development, as well as their market expansion strategies, play a crucial role in shaping the market[4].

Regulatory and Clinical Use

Fluticasone propionate is widely used in clinical practice for various indications, including asthma, COPD, and dermatological conditions like atopic dermatitis. The drug has been nominated for inclusion on the 503B Bulks List, which could further expand its use in compounded products. Clinical use and nominations highlight its efficacy and safety profile, supporting its continued market growth[5].

Challenges and Restraints

Despite the positive outlook, there are several challenges that the fluticasone propionate market faces:

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous compliance can impede market growth. Ensuring that products meet FDA standards is crucial but can be time-consuming and costly[3].
• Economic Factors: Economic downturns, such as those caused by the COVID-19 pandemic, can lead to reduced healthcare spending and delayed medical treatments, affecting market demand[3].

Future Outlook

The future of the fluticasone propionate market looks promising, driven by increasing demand for effective respiratory treatments and advancements in medical technology.

"Advances in medical technology have led to the development of more effective and targeted treatments for respiratory conditions. Novel drug delivery systems, such as nasal sprays and inhalers, offer improved efficacy and convenience for patients."[3]

Key Takeaways

• The global fluticasone propionate inhalers market is expected to grow at a CAGR of 4.6% from 2023 to 2032.
• The market is driven by increasing incidence of respiratory problems and technological advancements.
• Fluticasone propionate is more cost-effective than other inhaled corticosteroids like budesonide.
• North America is expected to dominate the market due to a large consumer base and high healthcare expenditure.
• Key players are investing in research and development to expand their product portfolios.

FAQs

What is the expected market size of fluticasone propionate inhalers by 2032?

The fluticasone propionate inhalers market is expected to reach USD 8.1 billion by 2032[1].

What is the CAGR of the fluticasone propionate inhalers market?

The market is expected to exhibit a CAGR of about 4.6% during the forecast period[1].

What are the key segments of the fluticasone propionate market?

The market is segmented based on type (60 metered sprays, 120 metered sprays, 150 metered sprays) and application (kids, adults)[1][4].

Why is fluticasone propionate more cost-effective than budesonide?

Fluticasone propionate is more cost-effective due to lower healthcare contact costs and better efficacy in improving symptoms and reducing episodes of respiratory distress[2].

Which region is expected to dominate the fluticasone propionate market?

North America is expected to dominate the market due to a large consumer base and high healthcare expenditure[3][4].

What are the main drivers of the fluticasone propionate market?

The main drivers include increasing incidence of respiratory problems and technological advancements in medical treatments[1][3].

Sources

1. Business Research Insights: Fluticasone Propionate Inhalers Market Size, Share & Report, 2032.
2. PubMed: The cost-effectiveness of inhaled fluticasone propionate.
3. Business Research Insights: Sinusitis Medicine Market Size [2024 to 2032] | Global Forecast.
4. Market Research Intellect: Global fluticasone propionate market size and forecast.
5. University of Maryland, Baltimore: Fluticasone propionate - Summary Report.