FLUTICASONE FUROATE - Generic Drug Details

What are the generic sources for fluticasone furoate and what is the scope of freedom to operate?

Fluticasone furoate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Haleon Us Holdings, and Glaxo Grp Ltd, and is included in four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate has one hundred and sixty-seven patent family members in twenty-four countries.

There are five drug master file entries for fluticasone furoate. Three suppliers are listed for this compound.

Summary for FLUTICASONE FUROATE

International Patents:	167
US Patents:	18
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	157
Patent Applications:	2,760
Drug Prices:	Drug price trends for FLUTICASONE FUROATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE FUROATE
What excipients (inactive ingredients) are in FLUTICASONE FUROATE?	FLUTICASONE FUROATE excipients list
DailyMed Link:	FLUTICASONE FUROATE at DailyMed

See drug prices for FLUTICASONE FUROATE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE

Constraining patent/regulatory exclusivity:

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971

Dosage:

POWDER;INHALATION

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FLUTICASONE FUROATE

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

Sponsor	Phase
Morten Hostrup, PhD	N/A
Novartis Pharmaceuticals	Phase 3
Assaf-Harofeh Medical Center	Phase 4

See all FLUTICASONE FUROATE clinical trials

Pharmacology for FLUTICASONE FUROATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE FUROATE

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

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

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 FUROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLONASE SENSIMIST ALLERGY RELIEF	Nasal Spray	fluticasone furoate	27.5 mcg	022051	1	2011-07-15

US Patents and Regulatory Information for FLUTICASONE FUROATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes

Expired US Patents for FLUTICASONE FUROATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018

EU/EMA Drug Approvals for FLUTICASONE FUROATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Avamys	fluticasone furoate	EMEA/H/C/000770 Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.	Authorised	no	no	no	2008-01-11
Glaxo Group Ltd.	Alisade	fluticasone furoate	EMEA/H/C/001019 Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.	Withdrawn	no	no	no	2008-10-06

International Patents for FLUTICASONE FUROATE

Country	Patent Number	Title	Estimated Expiration
Canada	2484592	DISPOSITIF DE DISTRIBUTION DE FLUIDE (A FLUID DISPENSING DEVICE)
South Africa	200410105	A fluid dispensing device
United Kingdom	0507224

Supplementary Protection Certificates for FLUTICASONE FUROATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111

FLUTICASONE FUROATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluticasone Furoate

Introduction to Fluticasone Furoate

Fluticasone furoate is a synthetic corticosteroid used in the treatment of various respiratory and skin conditions, including asthma, chronic obstructive pulmonary disease (COPD), and eczema. It is a key component in the pharmaceutical industry, particularly in the segment of inhaled corticosteroids.

Market Size and Growth

The global fluticasone market, which includes fluticasone furoate, is projected to experience significant growth over the coming years. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 5.5% from 2022 to 2030[3].

Historical and Forecast Periods

• The historical period for market analysis typically spans from 2019 to 2023, providing a baseline for current market conditions.
• The forecast period, from 2024 to 2031, indicates a promising outlook with continued growth driven by increasing demand for effective respiratory treatments[1][4].

Market Segmentation

By Product Type

Fluticasone furoate is one of the primary segments within the fluticasone market. In 2023, the fluticasone furoate segment accounted for a noticeable share of the global fluticasone market and is projected to experience significant growth in the near future[1].

By Application

The key applications of fluticasone furoate include:

• Antiasthmatic: This segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period.
• COPD Treatment Medicine: Increasing prevalence of COPD is driving the demand for fluticasone furoate.
• Eczema and Other Skin Conditions: Fluticasone furoate is also used in dermatological treatments, contributing to its market growth[4].

Regional Analysis

The fluticasone market, including fluticasone furoate, varies significantly across different regions due to factors such as raw material availability, regulatory environments, and healthcare infrastructure.

• North America: This region is expected to be a major contributor to the global market due to advanced healthcare systems and high demand for respiratory treatments.
• Europe: Europe also holds a significant share, driven by stringent regulatory standards and a strong pharmaceutical industry.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Market Drivers

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

Increasing Incidence of Respiratory Problems

The rising prevalence of asthma and COPD, particularly in urban areas due to air pollution, is a significant driver. This increase in respiratory problems necessitates more effective treatments, boosting the demand for fluticasone furoate[2].

Technological Advancements

Advancements in inhaler technology and the development of more efficient delivery systems are enhancing the efficacy of fluticasone furoate, making it a preferred choice among healthcare providers[2].

Regulatory and Environmental Factors

Environmental and safety regulations play a crucial role in shaping the chemical and pharmaceutical industries. Compliance with these regulations ensures the production of high-quality, environmentally friendly products, which in turn supports market growth[1].

Market Restraints

Despite the positive outlook, there are several restraints that could impact the market:

Cost and Accessibility

High costs associated with advanced inhaler technologies and the medication itself can limit accessibility, especially in developing regions. This can act as a barrier to market growth[5].

Competition from Generic Alternatives

The presence of generic alternatives and other corticosteroids can pose a competitive threat to branded fluticasone furoate products. Companies must continuously innovate and differentiate their products to maintain market share[1].

Financial Trajectory

Market Value

The global fluticasone propionate inhalers market, which includes fluticasone furoate, was valued at approximately USD 5.6 billion in 2023 and is expected to reach USD 8.1 billion by 2032, growing at a CAGR of 4.6%[2].

Revenue and CAGR

The overall fluticasone market is projected to grow at a CAGR of 5.5% from 2022 to 2030. This growth is driven by the increasing demand for fluticasone furoate in various therapeutic applications[3].

Key Players and Strategies

Major companies such as GSK, Teva, and others are focusing on strategy building to strengthen their product portfolios and expand their business in the global market.

• GSK: Known for its strong presence in the respiratory segment, GSK continues to innovate and expand its offerings, including fluticasone furoate products.
• Teva: Teva is another key player that is investing in technological advancements and strategic partnerships to enhance its market position[1][4].

Technological Trends

The market is witnessing significant technological advancements, particularly in inhaler devices. These advancements include the development of more efficient and user-friendly inhalers, which improve the delivery and efficacy of fluticasone furoate.

"Technological development and advancement are expected to deliver profitable opportunities for the market," highlighting the importance of innovation in driving market growth[2].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the pharmaceutical market. Patients and healthcare providers are increasingly seeking treatments that are not only effective but also convenient and safe. Fluticasone furoate, with its proven efficacy and safety profile, aligns well with these preferences.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the fluticasone market. While there was an initial disruption in supply chains and manufacturing, the pandemic also highlighted the importance of respiratory health, leading to increased demand for treatments like fluticasone furoate[1].

SWOT Analysis

Strengths

• Proven efficacy and safety profile.
• Strong demand driven by increasing respiratory problems.
• Technological advancements in delivery systems.

Weaknesses

• High costs associated with advanced inhaler technologies.
• Competition from generic alternatives.

Opportunities

• Growing demand in emerging markets.
• Expanding applications in dermatology and other areas.

Threats

• Regulatory changes and compliance issues.
• Economic fluctuations affecting healthcare expenditure.

Key Takeaways

• The fluticasone furoate market is expected to grow significantly, driven by increasing demand for respiratory treatments.
• Technological advancements and regulatory compliance are key drivers.
• Major players like GSK and Teva are focusing on innovation and strategic expansion.
• The market faces challenges from high costs and competition from generics.

FAQs

What is the expected CAGR of the fluticasone furoate market from 2022 to 2030?

The fluticasone market, including fluticasone furoate, is projected to grow at a CAGR of 5.5% from 2022 to 2030[3].

Which segment is expected to dominate the fluticasone furoate market?

The antiasthmatic segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[1].

What are the key drivers of the fluticasone furoate market?

Key drivers include the increasing incidence of respiratory problems, technological advancements, and regulatory and environmental factors[2].

Which region is expected to dominate the global fluticasone furoate market?

North America and Europe are expected to be major contributors, with the Asia-Pacific region showing rapid growth[1][4].

How does the COVID-19 pandemic impact the fluticasone furoate market?

The pandemic has highlighted the importance of respiratory health, leading to increased demand for treatments like fluticasone furoate, despite initial supply chain disruptions[1].

Sources

1. Global Fluticasone Market Report 2024 Edition - Cognitivemarketresearch.com
2. Fluticasone Propionate Inhalers Market Size, Share & Report, 2032 - Businessresearchinsights.com
3. Fluticasone Market Report | Global Forecast From 2023 To 2032 - Dataintelo.com
4. Global fluticasone market size and forcast - Marketresearchintellect.com
5. The cost-effectiveness of inhaled fluticasone propionate - PubMed.ncbi.nlm.nih.gov