Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

What are the generic drug sources for azelastine hydrochloride; fluticasone propionate and what is the scope of freedom to operate?

Azelastine hydrochloride; fluticasone propionate is the generic ingredient in two branded drugs marketed by Apotex, Padagis Israel, Teva Pharms Usa Inc, and Mylan Speciality Lp, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for azelastine hydrochloride; fluticasone propionate

International Patents:	57
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	6
Clinical Trials:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azelastine hydrochloride; fluticasone propionate
DailyMed Link:	azelastine hydrochloride; fluticasone propionate at DailyMed

Recent Clinical Trials for azelastine hydrochloride; fluticasone propionate

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	Phase 1
Wuhan Union Hospital, China	Phase 4
Zheng Liu ENT	Phase 4

See all azelastine hydrochloride; fluticasone propionate clinical trials

Pharmacology for azelastine hydrochloride; fluticasone propionate

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for azelastine hydrochloride; fluticasone propionate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AC	Antiallergic agents, excl. 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

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYMISTA	Nasal Spray	azelastine hydrochloride; fluticasone propionate	137 mcg/50 mcg per spray	202236	1	2014-06-13

US Patents and Regulatory Information for azelastine hydrochloride; fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111-001	Feb 18, 2021	AB	RX	No	No
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,168,620*PED				Y
Teva Pharms Usa Inc	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208436-001	Apr 8, 2025	AB	RX	No	No
Apotex	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	207712-001	Apr 28, 2017	AB	RX	No	Yes

Expired US Patents for azelastine hydrochloride; fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,901,585

International Patents for azelastine hydrochloride; fluticasone propionate

Country	Patent Number	Title	Estimated Expiration
Austria	428428
Australia	2003244799	COMBINATION OF AZELASTINE AND STEROIDS
Australia	2009243420	Combination of azelastine and steroids
Australia	2009243422	Combination of azelastine and steroids
Brazil	0312128	Formulação, produto farmacêutico, embalagem de pressão. mdi, pulverizador nasal, processos para preparar um produto farmacêutico e uma formulação e métodos para profilaxia ou tratamento em um mamìfero tal como um humano, de condições para as quais a administração de um ou mais anti-histamìnico e/ou um ou mais esteróides é indicada e para tratamento de irritação do distúrbios do nariz ou do olho e de distúrbios das vias aéreas
Brazil	122014030154

Supplementary Protection Certificates for azelastine hydrochloride; fluticasone propionate

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
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	CA 2013 00023	Denmark		PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215
1519731	PA2013023	Lithuania		PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1519731	40/2013	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 20130215
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Market dynamics and financial trajectory for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Last updated: April 24, 2026

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE is a combination intranasal therapy used primarily for allergic rhinitis and is sold under brand products in multiple markets. Commercial trajectory is shaped by (1) competitive pressure from established intranasal corticosteroids and antihistamine monotherapies, (2) switching dynamics toward fixed-dose combination regimens, (3) payer design that rewards formulary positioning, and (4) patent and exclusivity milestones tied to specific brand and formulation lines.

Below is the market-and-finance view investors and R&D strategists use: market drivers, competitive structure, pricing/reimbursement mechanics, and the financial trajectory signals that typically track for this class and specific combination format.

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What is the category and demand driver profile for this combination?

Therapeutic category

• Intranasal fixed-dose combination: antihistamine (azelastine) + intranasal corticosteroid (fluticasone).
• Primary use: allergic rhinitis, with symptom reduction focused on nasal congestion, rhinorrhea, sneezing, and itching.

Demand drivers

• Persistent prevalence of allergic rhinitis in developed markets and rising diagnosis rates in emerging markets.
• Guideline-driven movement toward combination regimens when monotherapy does not control symptoms.
• Patient adherence advantages when a single product replaces separate antihistamine and steroid dosing.
• Seasonal peaks (spring, fall) that drive quarterly and annual demand volatility.

What typically sustains unit volume

• Fixed-dose convenience and clinical differentiation versus either agent alone.
• Line extensions that improve dosing ease and patient tolerability (brand-level formulation specifics are critical).
• Broad payer adoption once a product establishes clinical-equivalent or superior outcomes under real-world formularies.

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How does competition shape market share and prescribing behavior?

Direct competitive set (same care setting)

• Other intranasal fixed-dose combinations (where present by market).
• Intranasal corticosteroid monotherapies (large installed base).
• Intranasal antihistamine monotherapies.
• Oral antihistamines in milder or comorbidity-driven cases.

Mechanics of share shift

• Physicians often start with monotherapy; combination uptake increases when:
  • Symptoms persist after initial steroid or antihistamine use.
  • Patient has comorbid ocular symptoms or multi-season symptom patterns.
  • Payer rules do not block combination access via step edits.
• Switchers frequently cite faster congestion relief and broader symptom coverage as justification.

Market structure implication

• Because intranasal corticosteroids already dominate baseline prescribing, the combination’s growth tends to come from:
  • Add-on switches
  • Steady capture from failing monotherapy
  • Replacement of multi-drug regimens with one product

Risks to share capture

• Aggressive generic entry for intranasal corticosteroids can cap price growth across the class.
• Competitive combinations that win preferential formulary placement can redirect switchers.

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What payer and pricing dynamics determine revenue trajectory?

Payer rules that typically govern performance

• Formulary status (preferred vs non-preferred)
• Prior authorization (PA) or step therapy (ST) criteria
• Quantity limits and days-supply rules (especially in seasonal programs)
• Patient copay management tied to rebate structures

Price corridor realities

• Intranasal rhinitis products are exposed to:
  • Competitive benchmarking against generics of intranasal corticosteroids
  • Rebate pressure in exchange for preferred formulary placement
• As the intranasal market matures, net price tends to compress faster than list price.

Implication for financial trajectory

• Revenue growth, when it occurs, usually depends on:
  • Unit growth that outpaces price erosion
  • Brand retention in preferred tiers
  • Sustained rebate economics with managed care contracts

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How do regulatory and exclusivity milestones affect the long-term financial path?

This combination’s brand economics are driven by exclusivity tied to:

• The original combination product approval and associated patent families
• Formulation/process patents that can extend brand protection beyond early-use composition coverage
• Local jurisdiction-specific patent term adjustments and regulatory exclusivity frameworks

Typical milestone effects

• Approaching expiration years:
  • Increased generic pipeline signaling
  • Payer behavior shifts toward substitution readiness
  • Brand promotional intensity rises to defend TRx and persistence
• After generic entry (if it occurs in a market):
  • Price erosion and share decline accelerate
  • Late-stage rebound is unlikely unless a brand line extension or new dosing paradigm is in place

Because exclusivity and patent scope are brand- and jurisdiction-specific, the financial trajectory should be tracked at the product line level, not just the active ingredients.

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What financial trajectory signals should investors track for this combination?

For AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE, the market-financial trajectory should be evaluated using measurable leading indicators:

1) Prescription and unit share momentum

• TRx or script share growth vs the intranasal corticosteroid baseline
• Seasonality pattern stability (does the product hold share during peak months)

2) Persistence and switching cohort behavior

• Continuation rates beyond first fill
• Switch-in rate from monotherapy and switch-out rate to other alternatives

3) Net pricing and contracting strength

• Evidence of net price stability versus list price drift
• Rebate rate changes tied to formulary negotiations

4) Market-level utilization intensity

• Growth in patients using combination therapy as a percent of treated allergic rhinitis population

5) Competitive response timing

• New product entrants’ effect on share after launch quarters
• Generic substitution impact onset timing by market

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How does the clinical positioning translate into adoption?

Clinical adoption pattern

• Combination therapy tends to be adopted when a patient needs both:
  • Rapid symptomatic relief (particularly congestion)
  • Sustained inflammatory control

Physician decision criteria

• Severity and symptom multiplicity (nasal blockage plus broader symptom burden)
• Prior treatment response
• Dosing simplicity and tolerability in real practice

Adoption ceiling

• If guidelines or payer pathways require monotherapy first, combination products face a ceiling on addressable volume.
• That ceiling rises when payers move the combination to earlier-line access.

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What are the biggest market risks to forecast accuracy?

1. Generic substitution timing in key markets
   Intranasal corticosteroids face genericization pressure; combination protection depends on jurisdiction-specific patent coverage.

2. Formulary tier deterioration
   Loss of “preferred” status typically drives immediate net revenue declines via TRx loss and rebate resets.

3. Competitive combination launches
   Alternative fixed-dose options can re-route switchers, especially if they win preferred access.

4. Seasonality and diagnosis volatility
   Uneven allergy seasons and changes in diagnosis rates can distort quarter-to-quarter demand.

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Market dynamics and financial trajectory: bottom-line interpretation

For AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE, the most likely financial trajectory in most therapeutic markets follows a pattern common to differentiated intranasal combination brands:

• Early-to-mid life: growth driven by switch from monotherapy, fortified by favorable payer placement and proven symptom coverage.
• Mature phase: slower growth with net price pressure as competitors gain traction and payers tighten rebate frameworks.
• Exclusivity endgame (if applicable): sharp compression risk tied to generic entry or formulary re-tiering unless the brand line extends.

The practical outcome is that revenue performance depends less on baseline allergic rhinitis prevalence and more on the combination product’s access position inside payer formularies and its ability to defend TRx through substitution threats.

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Key Takeaways

• AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE is a fixed-dose intranasal combination used for allergic rhinitis, with adoption driven by broader symptom coverage and switch potential from monotherapy.
• Market share and revenue trajectory are primarily governed by formulary tiering, PA/ST design, and net pricing mechanics rather than list price.
• The competitive battleground is the large intranasal corticosteroid monotherapy installed base plus antihistamine alternatives; combination growth requires overcoming payer and prescriber step hurdles.
• Long-term financial risk concentrates around exclusivity and patent-family endings that can trigger generic entry and rapid net revenue compression.
• Investors should monitor TRx momentum, persistence, and rebate-driven net price stability, with particular attention to seasonality and competitive launch timing.

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FAQs

1) What drives uptake of this azelastine and fluticasone combination?

Switching from monotherapy when symptoms persist, plus adherence benefits from single-product dosing and payer access that avoids restrictive step edits.

2) Why is net price more important than list price for this category?

Intranasal rhinitis products operate under rebate-heavy contracting; net price can compress quickly after formulary negotiations or generic threats.

3) How does seasonality affect revenue forecasts?

Demand peaks in allergy seasons can create strong quarterly volatility; forecasts should separate peak-month volume from underlying share momentum.

4) What is the largest structural risk to the financial trajectory?

Generic substitution and/or formulary re-tiering near exclusivity end, which can cause both price compression and TRx share loss.

5) What leading indicators best predict whether the product will grow or stall?

TRx share trend versus intranasal corticosteroid baseline, persistence after first fill, and net price stability tied to rebate and contract renewals.

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References (APA)

[1] FDA. (n.d.). Drug labels and approval information for azelastine and fluticasone combination products. U.S. Food & Drug Administration. https://www.fda.gov/
[2] EMA. (n.d.). European public assessment reports and product information for azelastine/fluticasone intranasal combinations. European Medicines Agency. https://www.ema.europa.eu/
[3] GINA. (n.d.). Global initiative for allergic rhinitis and related guidance resources. Global Initiative. https://www.ginasthma.org/