FLONASE SENSIMIST ALLERGY RELIEF Drug Patent Profile

Which patents cover Flonase Sensimist Allergy Relief, 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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty 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. Four 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:	120
US Patents:	3
Applicants:	1
NDAs:	1

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 three US patents.

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			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y

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
African Regional IP Organization (ARIPO)	1422	6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl)oxy!-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothioic acid s-fluoromethyl ester as an anti-inflammatory agent.
Argentina	032361	DERIVADOS DE ANDROSTANO Y SALES Y SOLVATOS DE LOS MISMOS, SU USO PARA LA FABRICACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN TALES COMPUESTOS, PROCESO PARA LA PREPARACION DE DICHOS COMPUESTOS, E INTERMEDIARIOS UTILES EN LA PREPARACION DE TALES COMPUESTOS
Argentina	032471	DERIVADO DE ANDROSTANO Y SOLVATOS DEL MISMO, SU USO PARA LA FABRICACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN, PROCESOS PARA PREPARAR TALES DERIVADOS, INTERMEDIARIOS UTILES EN LA PREPARACION DE TALES DERIVADOS, PROCESOS PARA PREPARAR TALES INTERMEDIARIOS, Y COMPUESTOS INTER
Argentina	038348	FORMULACIONES FARMACEUTICAS PARA ADMINISTRACION POR INHALACION
Argentina	038686	FORMULACIONES DE DERIVADOS DE ANDROSTANO Y AGONISTAS DEL ADRENORECEPTOR BETA 2 ANTIINFLAMATORIOS
Argentina	063555	DERIVADOS DE ANDROSTANO, SU USO EN LA FABRICACION DE MEDICAMENTOS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y PROCESOS PARA PREPARARLOS

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	CA 2008 00022	Denmark
1305329	SZ 12/2008	Austria		PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1305329	326	Finland
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	C 2008 007	Romania		PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111

Last updated: July 6, 2026

Investment Scenario and IP Fundamentals Analysis for FLONASE SENSIMIST ALLERGY RELIEF (Fluticasone Furoate Nasal Spray)

Flonase Sensimist Allergy Relief (active ingredient: fluticasone furoate) is an intranasal corticosteroid positioned in the U.S. allergy market alongside OTC competitors (mometasone, fluticasone propionate, budesonide). For an investment or licensing view, the decisive factors are (1) what patent estate still constrains generics/biosimilars in the U.S., (2) how much of market value is protected by formulation and device claims rather than the core API, and (3) the regulatory timeline for OTC switching, labeling changes, and generic entry risk.

No complete, accurate patent-expiration and Orange Book status mapping for this specific OTC product name can be produced from the information available in this session. Under the operating constraints, an incomplete or potentially wrong IP calendar is not included.

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What patents protect Flonase Sensimist (fluticasone furoate) nasal spray in the US?

Featured snippet answer: A complete, product-specific U.S. patent and exclusivity map for “Flonase Sensimist Allergy Relief” requires current Orange Book and patent list retrieval tied to the exact NDA/ANDA product code. That mapping is not available in this session, so a numbered patent-by-patent estate cannot be stated here without risking errors.

What typically matters for IP in intranasal fluticasone products

For intranasal corticosteroids, the enforceable IP landscape often splits into:

• Composition/formulation patents (particle size, surfactants, vehicle, preservatives, osmolarity/pH, droplet distribution)
• Device and delivery-mechanism patents (spray plume characteristics, nozzle geometries)
• Method-of-use patents (specific dosing regimens, pediatric indications if claimed)
• Medical benefit claims (symptom relief targets, timing claims tied to clinical endpoints)

Where “Sensimist” usually creates legal differentiation

“Sensimist” branding generally indicates a particular formulation and delivery profile distinct from other fluticasone brands (including earlier fluticasone propionate products). In practice, that means the enforceable moat, if any, is more likely to sit in formulation/device claims than in the underlying corticosteroid molecule itself.

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When does Flonase Sensimist lose exclusivity and what are generic entry risks?

Featured snippet answer: A defensible exclusivity and generic entry scenario depends on the exact U.S. reference product listing, relevant Orange Book patents, and any pediatric exclusivity or other statutory exclusivities. Those inputs are not available in this session, so no expiration dates or Paragraph IV window can be stated.

Generic entry risk drivers investors track

Even without a precise patent calendar, market entry risk usually follows these mechanics:

• If core formulation/device patents expire, generics can often launch with bioequivalence using the same API and similar spray characteristics
• If remaining patents are narrow to a specific formulation parameter or device geometry, litigation risk can shift to “design-around” feasibility
• OTC status can increase substitution speed once labeling permits interchangeability and pharmacist/consumer substitution accelerates

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What is the Orange Book status of Flonase Sensimist Allergy Relief?

Featured snippet answer: Orange Book status is specific to the NDA/ANDA product listed under the exact reference and dosage form. A current Orange Book table for Flonase Sensimist is not available in this session.

How investors use Orange Book status in practice

An Orange Book view is typically used to:

• Identify “Orange Book-listed” patents that must be addressed by ANDA filers
• Determine which patents appear most vulnerable to paragraph IV challenges
• Estimate the likelihood of delayed launches via litigation stay or settlement

Without the Orange Book listing, any claim about “listed patents” or “remaining patents” would be speculative.

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How strong is the patent estate for fluticasone furoate nasal spray (and how does it compare with fluticasone propionate)?

Featured snippet answer: Patent strength can be compared only with a side-by-side claim chart of remaining Orange Book-listed patents for the relevant U.S. reference products. That dataset is not available in this session.

Framework for patent strength scoring (used by investors)

Investors commonly score:

• Remaining term on key claim families (composition/formulation vs device)
• Claim breadth (functional language vs specific parameter ranges)
• Litigation history (settlements, adverse rulings, consistent enforcement)
• “Design-around” risk (can a generic match performance without infringing?)

Market reality investors model

Even if a molecule is off-patent, brand equity and consumer familiarity can slow price erosion. Conversely, intranasal OTC brands with interchangeable dosing and overlapping symptom claims can compress pricing quickly when generics are cleared.

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What formulations and delivery systems are protected for Flonase Sensimist?

Featured snippet answer: Product-specific formulation and device claim coverage requires the exact patent family list tied to the fluticasone furoate nasal spray “Sensimist” product. That list is not provided in this session.

Typical formulation differentiators in intranasal corticosteroids

Investors evaluating “Sensimist-style” assets look for protections around:

• Excipients and vehicle (stabilizers, polymers, surfactants)
• Particle size and suspension characteristics
• Preservative system and pH ranges
• Spray plume pattern and droplet size distribution
• Heat or viscosity stabilization for shelf life and consistent actuation

Delivery system differentiators

Delivery IP often focuses on:

• Nozzle geometry
• Pump mechanism tolerances
• Metering chamber design
• Actuation consistency across temperature ranges

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What patent litigation affects fluticasone furoate nasal spray and related OTC generics?

Featured snippet answer: Litigation impact is product and jurisdiction specific and requires a docket-level listing of ANDA/Paragraph IV cases against the relevant reference product. That information is not available in this session.

What investors need from litigation dockets (what would be analyzed)

• Whether any cases were filed under Paragraph IV against Orange Book patents
• Whether there was a settlement triggering a 30-month stay or earlier agreed launch date
• Whether any court rulings narrowed or invalidated claims
• Whether injunctions were sought and granted

Absent docket data, litigation conclusions would be unreliable.

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What FDA regulatory status applies to Flonase Sensimist (OTC vs prescription) and how does it shape market exposure?

Featured snippet answer: The FDA regulatory posture for fluticasone nasal spray determines labeling interchangeability and substitution rates. A precise OTC status timeline and any FDA labeling exclusivity metrics for this specific product cannot be listed without the product’s current regulatory history, which is not present in this session.

How investors model regulatory exposure

• OTC monograph or NDA-to-OTC switching, if applicable, changes the substitution and distribution channel economics
• Pediatric labeling changes can expand addressable population if supported by evidence and labeling
• Citizen petitions, REMS-like changes (rare for intranasals), or labeling restrictions can affect growth trajectories

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How does Flonase Sensimist compare with major intranasal competitors (pricing, substitutability, and patent/IP posture)?

Featured snippet answer: A complete investment-grade comparison requires current U.S. market price/volume data and the corresponding IP calendars for each comparator product. That information is not available in this session.

Comparator set typically used in intranasal allergy portfolios

Investors usually compare across:

• Fluticasone furoate nasal products (brands using different formulations)
• Fluticasone propionate nasal sprays (including prescription and OTC versions)
• Mometasone furoate (e.g., Nasonex class)
• Budesonide nasal spray

In this session, no validated price or patent calendar data can be produced.

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What commercial metrics and revenue sensitivity matter for an intranasal OTC investment case?

Featured snippet answer: For OTC allergy intranasals, profitability sensitivity is driven by net price, trade terms, promotional cadence, and generic substitution velocity. A quantified model requires current sales, channel mix, and pricing data, which are not provided here.

Core drivers for downside and upside scenarios

• Generic arrival timing relative to consumer brand entrenchment
• Gross margin impact from promotional intensity and payer-like OTC pricing pressure
• Shelf presence and retailer planogram allocations
• Form-factor expansion (seasonal bundling, store brands, multi-packs)
• Litigation and labeling changes that can reduce retailer confidence or consumer switching

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Key Takeaways

• Flonase Sensimist Allergy Relief is an OTC intranasal corticosteroid powered by fluticasone furoate, where IP and formulation/device differentiation typically matter more than the molecule itself.
• An investment-grade view depends on the exact U.S. Orange Book listing, remaining patents, and any statutory exclusivities tied to the specific reference product. Those artifacts are not available in this session, so no expiration calendar, Paragraph IV risk window, or litigation-driven launch dates are stated.
• Commercial outcomes for intranasal OTC assets track generic substitution speed, retailer adoption, and promotional intensity more than prescription-specific dynamics.

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FAQs

1. What drives market substitution speed for OTC intranasal corticosteroids?
2. How do formulation and device patents differ from method-of-use patents in intranasal generics?
3. What settlement terms are typical in ANDA Paragraph IV cases for nasal sprays?
4. How do OTC labeling changes affect retailer distribution and consumer switching?
5. What metrics best predict gross margin compression after generic entry for allergy sprays?

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References

1. (No citations provided; the session does not include Orange Book, FDA, or docket sources needed to support specific patent, exclusivity, or regulatory statements.)