FLUTICASONE PROPIONATE Drug Patent Profile

When do Fluticasone Propionate patents expire, and what generic alternatives are available?

Fluticasone Propionate is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Taro Pharm Inds, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, and Teva Pharms Usa. and is included in twenty-two NDAs.

The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fluticasone Propionate

A generic version of FLUTICASONE PROPIONATE was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for FLUTICASONE PROPIONATE

US Patents:	0
Applicants:	14
NDAs:	22
Finished Product Suppliers / Packagers:	67
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	365
Patent Applications:	5,456
Drug Prices:	Drug price information 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
Cosette	FLUTICASONE PROPIONATE	fluticasone propionate	CREAM;TOPICAL	077055-001	Jun 30, 2006	AB	RX	No	No
Hikma	FLUTICASONE PROPIONATE	fluticasone propionate	SPRAY, METERED;NASAL	077570-001	Jan 16, 2008		DISCN	No	No
Teva Pharms Usa	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213948-001	Dec 13, 2021	AB	RX	No	No

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.