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flonase sensimist allergy relief Drug Patent Profile

When do Flonase Sensimist Allergy Relief patents expire, and what generic alternatives are available?

Flonase Sensimist Allergy Relief is a drug marketed by Haleon Us Holdings and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-one patent family members in twenty-three countries.

The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Flonase Sensimist Allergy Relief

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 15, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for flonase sensimist allergy relief

International Patents:	121
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	1,431
DailyMed Link:	flonase sensimist allergy relief at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for flonase sensimist allergy relief

Constraining patent/regulatory exclusivity:

8,347,879

NDA:

022051

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.

Pharmacology for flonase sensimist allergy relief

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for FLONASE SENSIMIST ALLERGY RELIEF

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 flonase sensimist allergy relief

flonase sensimist allergy relief is protected by four US patents.

This potential generic entry date is based on patent 8,347,879.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,347,879		Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,147,461		Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,062,264		Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	9,320,862		Y

Expired US Patents for flonase sensimist allergy relief

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	6,858,596
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	9,320,862
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	7,101,866
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	7,541,350

EU/EMA Drug Approvals for flonase sensimist allergy relief

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 flonase sensimist allergy relief

See the table below for patents covering flonase sensimist allergy relief around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	063555	DERIVADOS DE ANDROSTANO, SU USO EN LA FABRICACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y PROCESOS PARA PREPARARLOS
Poland	1723052
China	1930054	A fluid dispensing device
Canada	2417826	DERIVES DE 17-BETA-CARBOTHIOATE-17-ALPHA-ARYLCARBONYLOXYLOXY ANDROSTANE UTILISES COMME ANTI-INFLAMMATOIRES (17.BETA.-CARBOTHIOATE 17.ALPHA.-ARYLCARBONYLOXYLOXY ANDROSTANE DERIVATIVE AS ANTI-INFLAMMATORY AGENTS)

Supplementary Protection Certificates for flonase sensimist allergy relief

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
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	CA 2008 00022	Denmark
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

Flonase sensimist allergy relief Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLONASE SENSIMIST Allergy Relief

Introduction to FLONASE SENSIMIST

FLONASE SENSIMIST, introduced by GSK Consumer Healthcare, is a revolutionary over-the-counter (OTC) treatment for seasonal and perennial allergic rhinitis. This product stands out with its unique MistPro™ technology, providing a fine, gentle, yet powerful mist spray that offers non-drowsy, 24-hour relief from various allergy symptoms[1][2].

Market Need and Demand

Allergies affect a significant portion of the population, with over 50 million Americans suffering from them. This widespread prevalence creates a substantial market demand for effective allergy relief products. FLONASE SENSIMIST addresses this need by offering a comprehensive solution that targets multiple inflammatory substances, unlike many OTC allergy pills that only act on histamine[1].

Unique Selling Points

Advanced Technology

FLONASE SENSIMIST utilizes MistPro™ technology, which delivers a gentle and powerful mist spray. This technology ensures consistent dosing and minimal drip, making it a preferred choice for consumers seeking a user-friendly and effective product[1][2].

Multi-Symptom Relief

Unlike single-ingredient antihistamines, FLONASE SENSIMIST acts on six key inflammatory substances, including histamine, prostaglandins, cytokines, tryptases, chemokines, and leukotrienes. This multi-action approach provides relief from a wide range of symptoms such as sneezing, runny nose, itchy nose, nasal congestion, and itchy, watery eyes[1][2].

Ergonomic Design

The product features a scent-free, alcohol-free formula and a short nozzle, making it less invasive and more comfortable to use. These design elements enhance the user experience and contribute to its market appeal[1].

Market Competition

The allergy relief market is highly competitive, with several well-known brands such as Zyrtec, Claritin, Allegra, and Nasacort. However, FLONASE SENSIMIST differentiates itself through its unique technology and comprehensive symptom relief. It is positioned as a more complete solution compared to traditional OTC allergy pills that often fail to address nasal congestion[2].

Financial Performance and Projections

Current Market Size

While specific financial data for FLONASE SENSIMIST alone is not publicly available, the broader market for fluticasone propionate products, which includes inhalers and nasal sprays, provides some context. The global fluticasone propionate inhalers market was valued at approximately USD 5.6 billion in 2023 and is expected to grow to USD 8.1 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 4.6%[3].

Revenue Growth

Given its unique features and strong market positioning, FLONASE SENSIMIST is likely to contribute significantly to GSK Consumer Healthcare's revenue. The product's approval for OTC availability in 2016 and its subsequent nationwide launch have likely boosted sales, although exact figures are not disclosed.

Market Segmentation

The market for fluticasone propionate products is segmented based on type (e.g., 60 metered sprays, 120 metered sprays) and application (kids, adults). FLONASE SENSIMIST, being part of this broader market, benefits from these segmentation strategies, catering to both adult and pediatric populations[3].

Driving Factors

Increasing Incidence of Respiratory Problems

The rising incidence of respiratory issues, including allergies and asthma, drives the demand for effective treatments like FLONASE SENSIMIST. This trend is expected to continue, supporting the growth of the market[3].

Technological Advancements

Continuous technological advancements in drug delivery systems, such as the MistPro™ technology used in FLONASE SENSIMIST, enhance product efficacy and user experience. These innovations are crucial for maintaining market competitiveness and attracting new consumers[3].

Consumer Feedback and Market Acceptance

Consumer feedback on FLONASE SENSIMIST has been positive, with many users reporting significant relief from their allergy symptoms. Testimonials highlight the product's effectiveness in managing severe allergies, improving quality of life for sufferers[2].

Sustainability Initiatives

GSK Consumer Healthcare has also emphasized sustainability with FLONASE products, including the introduction of recyclable paper packaging for Adult FLONASE and FLONASE SENSIMIST sprays. This initiative not only appeals to environmentally conscious consumers but also aligns with broader industry trends towards sustainability[4].

Key Takeaways

• Unique Technology: FLONASE SENSIMIST uses MistPro™ technology to deliver a gentle yet powerful mist spray.
• Comprehensive Relief: It acts on six key inflammatory substances, providing relief from multiple allergy symptoms.
• Market Demand: The product addresses a significant market need, given the high prevalence of allergies.
• Financial Growth: The broader fluticasone propionate market is expected to grow, with FLONASE SENSIMIST likely contributing to this growth.
• Consumer Acceptance: Positive consumer feedback and strong market positioning support its financial trajectory.

FAQs

What is the unique technology used in FLONASE SENSIMIST?

FLONASE SENSIMIST uses MistPro™ technology, which delivers a fine, gentle, yet powerful mist spray for effective allergy relief[1][2].

How does FLONASE SENSIMIST compare to other allergy medications?

FLONASE SENSIMIST acts on six key inflammatory substances, unlike most OTC allergy pills that only act on histamine, providing more comprehensive relief[1][2].

Is FLONASE SENSIMIST available for children?

Yes, FLONASE SENSIMIST is indicated for itchy, watery eyes in adults and children 12 years of age and older[2].

What are the key driving factors for the market growth of FLONASE SENSIMIST?

The increasing incidence of respiratory problems and technological advancements are key drivers for the market growth of FLONASE SENSIMIST[3].

Does FLONASE SENSIMIST have any sustainability initiatives?

Yes, GSK Consumer Healthcare has introduced recyclable paper packaging for Adult FLONASE and FLONASE SENSIMIST sprays, aligning with sustainability trends[4].

Sources

1. GSK Consumer Healthcare. GSK Consumer Healthcare Launches FLONASE® Sensimist™ Allergy Relief Nationwide. Retrieved from https://us.gsk.com/en-us/media/press-releases/gsk-consumer-healthcare-launches-flonase-sensimist-allergy-relief-nationwide/
2. FLONASE. FLONASE SENSIMIST. Retrieved from https://www.flonase.com/products/sensimist/
3. Business Research Insights. Fluticasone Propionate Inhalers Market Size, Share & Report, 2032. Retrieved from https://www.businessresearchinsights.com/market-reports/fluticasone-propionate-inhalers-market-110930
4. FLONASE. Multi-Symptom Allergy Relief Sprays and Caplets | FLONASE. Retrieved from https://www.flonase.com
5. Metro Market. Flonase Sensimist Allergy Relief Non Drowsy Fluticasone Furoate Medicine Gentle Mist Nasal Spray. Retrieved from https://www.metromarket.net/p/flonase-sensimist-allergy-relief-non-drowsy-fluticasone-furoate-medicine-gentle-mist-nasal-spray/0035310020215