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Last Updated: December 22, 2024

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FLONASE SENSIMIST ALLERGY RELIEF Drug Patent Profile


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Which patents cover Flonase Sensimist Allergy Relief, and when can generic versions of Flonase Sensimist Allergy Relief launch?

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

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Summary for FLONASE SENSIMIST ALLERGY RELIEF
Drug patent expirations by year for FLONASE SENSIMIST ALLERGY RELIEF
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FLONASE SENSIMIST ALLERGY RELIEF
Generic Entry Date for FLONASE SENSIMIST ALLERGY RELIEF*:
Constraining patent/regulatory exclusivity:
NDA:
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
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLONASE SENSIMIST ALLERGY RELIEF is ⤷  Subscribe.

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

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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
China 1901958 A fluid dispensing device ⤷  Subscribe
New Zealand 562288 A fluid dispensing device with an actuator that actuates the dispenser when a minimum force is applied in a direction transverse to the dispenser ⤷  Subscribe
Austria 453421 ⤷  Subscribe
China 1930054 A fluid dispensing device ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 2018C/022 Belgium ⤷  Subscribe 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
2506844 LUC00077 Luxembourg ⤷  Subscribe 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 SPC011/2008 Ireland ⤷  Subscribe SPC011/2008: 20081105, EXPIRES: 20230110
2506844 SPC/GB18/020 United Kingdom ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.