Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

What are the generic 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.

Azelastine hydrochloride; fluticasone propionate has fifty-seven patent family members in twenty-seven countries.

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
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No					Y
Apotex	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	207712-001	Apr 28, 2017	AB	RX	No	Yes
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

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
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012

International Patents for azelastine hydrochloride; fluticasone propionate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2075000	Combinaison d'azélastine et du ciclésonide (Combination of azelastine and ciclesonide)
Australia	2009243420	Combination of azelastine and steroids
European Patent Office	1519731	ASSOCIATION D'AZELASTINE ET DE FLUTICASONE (COMBINATION OF AZELASTINE AND FLUTICASONE)

Supplementary Protection Certificates for azelastine hydrochloride; fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218

Market Dynamics and Financial Trajectory for Azelastine Hydrochloride and Fluticasone Propionate

Last updated: July 28, 2025

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Introduction

The pharmaceutical market for azelastine hydrochloride and fluticasone propionate encompasses allergy and respiratory treatments, with a robust demand driven by increasing prevalence of allergic rhinitis, asthma, and chronic obstructive pulmonary disease (COPD). These compounds form core components of established drug classes—antihistamines and intranasal corticosteroids—posing both market stability and growth opportunities for pharmaceutical developers and investors.

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Market Overview

Azelastine hydrochloride, an antihistamine with both oral and intranasal formulations, and fluticasone propionate, an intranasal corticosteroid, together address respiratory inflammatory conditions. The global allergic rhinitis market alone was valued at approximately USD 10.4 billion in 2022 and is projected to expand at a Compound Annual Growth Rate (CAGR) of about 6.2% through 2030. This growth is underpinned by rising pollution levels, urbanization, and increased awareness and diagnosis of allergy-related ailments.

Market Drivers

• Rising Prevalence of Allergic Diseases: According to the World Allergy Organization, over 30% of the global population suffers from allergic rhinitis, with similarly high rates for asthma (around 262 million cases worldwide in 2019 [1]). The burden directly influences demand for medications like azelastine and fluticasone.

• Advancements in Delivery Technologies: Innovations in nasal spray formulations enhance drug bioavailability and patient compliance, fueling the market. For instance, the development of improved spray devices increases market penetration.

• Expanding Approvals and Line Extensions: Regulatory agencies have approved new indications and fixed-dose combinations, broadening the therapeutic use spectrum. Such expansions incentivize manufacturers to increase production and seek patent protections.

• Growing Aging Population: Elderly populations are more prone to respiratory conditions, enhancing pediatric and geriatric market segments for intranasal therapies.

• Patent Expiries and Generics: While key patents for flagship products have expired, multiple generics have entered markets, intensifying competition but also reducing consumer prices, thereby expanding access and volume sales.

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Competitive Landscape and Market Players

Major players include GlaxoSmithKline, Teva Pharmaceuticals, Novartis, and Mylan. These companies hold patents or market exclusivity for leading formulations, with ongoing R&D efforts aimed at improving delivery systems and combination therapies. The generic segment's expansion has intensified pricing pressures but simultaneously elevated accessible treatment rates.

Market Challenges

• Generic Competition and Price Erosion: The expiration of patent protections results in commodification of formulations, leading to downward pricing trends.

• Stringent Regulatory Environments: Evolving safety standards and approval processes, especially in emerging markets, increase time-to-market and operational costs.

• Patient Adherence and Satisfaction: Metered-dose nasal sprays' application complexity can hinder widespread adoption. Companies focus on patient-centric designs to counteract this.

• Market Saturation in Developed Countries: High market penetration reduces growth prospects but prompts companies to seek emerging markets for expansion.

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Financial Trajectory

Revenue Streams and Growth Potential

The combined market for azelastine and fluticasone-based therapies is expected to grow at a CAGR of approximately 6% over the next decade. Key revenue contributors are the nasal spray formulations, which account for over 70% of sales due to ease of use and favorable safety profiles.

Impact of Patent Expirations

Patent expiries within the next 3-5 years will lead to increased generic sales. For example, the blockbuster Flonase (fluticasone propionate) had patents expired in multiple markets since 2014 [2], prompting a shift toward price-based competition, but also expanding treatment access.

R&D and Pipeline Developments

Investments in R&D aim to develop bioequivalent generics, combination therapies, and drug delivery innovations. Such endeavors bolster long-term revenues by prolonging market exclusivity and enhancing efficacy.

Emerging Markets and Access

Markets in Latin America, Asia-Pacific, and Africa present significant growth opportunities. Rising disposable incomes and health awareness are increasing prescription volumes, although market entry is challenged by regulatory complexities and pricing controls.

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Regulatory and Policy Influences

Regulatory agencies such as the FDA and EMA have streamlined approval pathways for biosimilars and generics, potentially accelerating market entry and competition. Conversely, recent policies emphasizing drug pricing transparency and cost control may cap revenue growth in regulated markets.

Future Outlook

• Growth through Innovative Formulations: Sustained R&D will focus on nasal spray devices with enhanced delivery and reduced dosing frequency, boosting user adherence and retention.

• Expansion into New Indications: Research into allergic conjunctivitis, nasal polyps, and other inflammatory conditions may diversify revenue streams.

• Digital and Data-Driven Strategies: Incorporating telemedicine and digital therapeutics can increase market reach and improve treatment outcomes, indirectly elevating product demand.

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Conclusion: Market and Financial Outlook

The pharmaceutical market for azelastine hydrochloride and fluticasone propionate remains resilient despite patent expiries and competitive pressures. Revenue growth will be primarily driven by expansion into emerging markets, innovation in drug delivery, and pipeline diversification. Companies adopting aggressive R&D, strategic partnerships, and market penetration strategies will position themselves to capitalize on the ongoing demand spike.

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Key Takeaways

• The global allergy and respiratory treatment markets are expected to grow steadily, with CAGR around 6%, fueled by disease prevalence and technological advancements.
• Patent expiries are catalyzing a transition toward a fragmented landscape dominated by generics, influencing revenue trajectories and pricing strategies.
• Innovation in delivery devices and combination therapies remains critical for sustaining market share and enhancing patient adherence.
• Emerging markets present lucrative opportunities, though regulatory hurdles and pricing policies require strategic navigation.
• Continuous R&D investment in pipeline development and digital health solutions will be pivotal for long-term financial growth.

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FAQs

1. How will patent expirations impact the revenues of azelastine hydrochloride and fluticasone propionate?
Patent expirations will likely reduce revenues from branded formulations. However, the influx of generics can expand overall market volume by lowering prices and increasing accessibility, partially offsetting revenue declines for original patentees.

2. What are the key innovations driving growth in this segment?
Advancements include nasal spray devices with improved delivery mechanisms, combination therapies for broader indications, and personalized medicine approaches, all improving efficacy and patient adherence.

3. Which regions present the highest growth prospects for these drugs?
Emerging markets in Asia-Pacific, Latin America, and Africa offer significant growth potential due to increasing disease prevalence, rising incomes, and expanding healthcare infrastructure.

4. How do regulatory policies influence the market trajectory?
Stringent regulations can delay product launches but also ensure safety and efficacy, maintaining market integrity. Streamlined approval pathways for biosimilars and generics facilitate faster market entry, intensifying competition.

5. What strategic moves should pharmaceutical companies prioritize to capitalize on this market?
Investing in innovation, entering emerging markets, developing biosimilars and combination therapies, and leveraging digital health solutions are critical strategies to sustain competitive advantage and financial growth.

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References

[1] World Allergy Organization. "The Global Surveillance of Allergic Disease." 2019.

[2] U.S. Food and Drug Administration. “Patent Expiration Data for Fluticasone Propionate,” 2014.

[3] MarketWatch. "Allergic Rhinitis Market Size and Growth Analysis," 2022.

[4] Deloitte. "Pharmaceutical Patents and Market Strategies," 2021.

Note: The data and projections referenced are based on industry reports, market analyses, and published statistics as of 2022–2023, with ongoing updates anticipated pending new regulatory and scientific developments.