DYMISTA Drug Patent Profile

Which patents cover Dymista, and when can generic versions of Dymista launch?

Dymista is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in twenty-seven countries.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dymista

A generic version of DYMISTA was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28^th, 2017.

Summary for DYMISTA

International Patents:	57
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	13
Patent Applications:	70
Drug Prices:	Drug price information for DYMISTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYMISTA
What excipients (inactive ingredients) are in DYMISTA?	DYMISTA excipients list
DailyMed Link:	DYMISTA at DailyMed

See drug prices for DYMISTA

See drug sales revenues for DYMISTA

Recent Clinical Trials for DYMISTA

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	Phase 1
St. Paul's Sinus Centre	Phase 4
MEDA Pharma GmbH & Co. KG	Phase 4

See all DYMISTA clinical trials

Pharmacology for DYMISTA

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

Paragraph IV (Patent) Challenges for DYMISTA

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 DYMISTA

DYMISTA is protected by one US patents.

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

Expired US Patents for DYMISTA

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 DYMISTA

When does loss-of-exclusivity occur for DYMISTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

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

See the table below for additional patents covering DYMISTA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2779633	ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS)
European Patent Office	2075000	Combinaison d'azélastine et du ciclésonide (Combination of azelastine and ciclesonide)
Denmark	2075000
World Intellectual Property Organization (WIPO)	03105856
Cyprus	1116693
Austria	428428

Supplementary Protection Certificates for DYMISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	175 5006-2013	Slovakia		PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
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	1390033-7	Sweden		PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215

Market Dynamics and Financial Trajectory for DYMISTA

Last updated: October 21, 2025

Introduction

DYMISTA (azelastine hydrochloride and fluticasone propionate), a novel intranasal corticosteroid-antihistamine combination, has established itself within the allergy and allergic rhinitis treatment landscape. Market dynamics surrounding DYMISTA are driven by clinical efficacy, regulatory strategies, competitive positioning, and evolving market needs. Analyzing its financial trajectory requires understanding its market penetration, pipeline developments, and broader industry trends impacting its growth.

Market Overview

DYMISTA, developed jointly by Mylan (now part of Viatris) and Mundipharma, entered a competitive segment characterized by an increasing prevalence of allergic rhinitis globally. The global allergic rhinitis therapeutics market was valued at approximately USD 9.4 billion in 2021 and is projected to grow at a CAGR of around 4.2% through 2030, propelled by rising awareness and healthcare infrastructure expansion, particularly in emerging markets [1].

The drug’s primary markets include the United States, Europe, and select Asia-Pacific countries. Its positioning as a treatment for moderate to severe allergic rhinitis provides a niche yet significant market share, especially among patients inadequately managed with monotherapy.

Market Dynamics Influencing DYMISTA

1. Clinical Efficacy and Patient Preference

DYMISTA's unique formulation combines an antihistamine (azelastine) with a corticosteroid (fluticasone), offering rapid symptom relief and addressing multiple pathways of allergic inflammation. Clinical trials demonstrate superior efficacy over monotherapies in multiple symptom domains [2]. This efficacy enhances its market appeal among physicians seeking comprehensive treatment options, particularly for patients with refractory symptoms.

2. Competitive Landscape

DYMISTA faces competition from established intranasal corticosteroids (e.g., fluticasone, mometasone) and antihistamines (e.g., loratadine, cetirizine), both of which benefit from broad OTC availability and entrenched prescriber habits. Recently, physiological challenges such as generics, new delivery platforms (e.g., nasal sprays with improved bioavailability), and novel fixed-dose combinations have intensified competition [3].

3. Regulatory Factors and Approvals

Regulatory approval status remains pivotal. DYMISTA is approved by the FDA and EMA, which facilitates access in major markets. Patent protection and exclusivity periods influence its pricing power and market penetration strategies. Any imminent patent expiries threaten potential price erosion, prompting companies to pursue line extensions or new formulations.

4. Pricing and Reimbursement Policies

Pricing strategies vary across markets, heavily influenced by reimbursement policies. In the US, DYMISTA’s positioning as a prescription product with proven efficacy allows for premium pricing, but cost-sensitive healthcare systems in Europe and emerging markets may limit optimal reimbursement, impacting sales volume.

5. Adoption Trends and Physician Prescribing Behavior

Physicians tend to reserve combination therapies like DYMISTA for refractory cases. The drug’s growth trajectory relies on prescriber awareness campaigns, evidence dissemination, and real-world data supporting its clinical advantages.

Financial Trajectory

Revenue Performance

Since launch, DYMISTA has experienced steady adoption. In the US, it generated approximately USD 250 million in sales in 2021, with gradual growth observed in subsequent years [4]. Regulatory approvals in Europe and Asia-Pacific expanded its market footprint, though initial revenues there are lower due to market access and distribution hurdles.

Growth Drivers

• Expanding Indications: Potential research into pediatric use and broader allergic conditions could extend its market.
• Market Penetration Strategies: Enhanced marketing, clinical education, and placement in specialized allergy clinics bolster adoption.

Challenges to Growth

• Generic Competition: imminent patent expirations could dilute revenue streams unless supplemented by line extensions.
• Market Saturation: As a mature product, DYMISTA faces saturation in primary markets, necessitating innovation or repositioning.
• Pricing Pressures: Cost containment policies threaten premium pricing models.

Future Outlook

Projections suggest a compound annual growth rate of 3-5% in DYMISTA’s revenue over the next five years, conditioned upon successful market expansion and stabilization against generic erosion. Its financial trajectory will be significantly influenced by pipeline developments, potential new formulations, and market-specific reimbursement reforms.

Strategic Considerations

Pipeline and Line Extensions

Companies could pursue new dosage forms, such as once-daily options or combination formulations with newer antihistamines, to sustain growth. Moreover, expanding indications, like allergic conjunctivitis or non-allergic rhinitis, may diversify revenue streams.

Partnership and Licensing Opportunities

Strategic alliances in emerging markets can accelerate expansion, while licensing deals for innovative delivery platforms could foster differentiation.

Regulatory and Patent Strategy

Proactive patent management and pursuit of regulatory exclusivities remain critical to safeguarding revenue for DYMISTA and its successors.

Conclusion

DYMISTA’s market dynamics are shaped by a confluence of clinical efficacy, competitive pressures, regulatory landscapes, and pricing policies. Its financial trajectory appears steady, supported by expanding markets and robust clinical positioning but faces headwinds from generic competition and evolving reimbursement paradigms. Strategic innovation, market expansion, and continuous evidence generation will determine its long-term profitability and market standing.

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Key Takeaways

• Market Expansion: Growth prospects hinge on geographic expansion, especially in Asia-Pacific and South America, where allergy prevalence is rising.
• Competitive Differentiation: Demonstrating superior efficacy and patient adherence remains vital amidst increasing generic competition.
• Pipeline Development: Line extensions and new formulations can prolong the product lifecycle and sustain revenue.
• Reimbursement and Pricing: Navigating reimbursement policies will be critical to maintaining premium pricing and access.
• Regulatory Vigilance: Patents and exclusivities should be actively managed, with strategic planning for patent expirations and new approvals.

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FAQs

1. What therapeutic advantages does DYMISTA offer over monotherapy options?
DYMISTA combines an antihistamine and corticosteroid in a single nasal spray, providing rapid, comprehensive symptom relief for allergic rhinitis, especially in cases refractory to monotherapy, with improved patient adherence.

2. How imminent is the patent expiration for DYMISTA, and what are its implications?
Patent protection in key markets is generally projected to expire within the next 2-4 years, potentially leading to generic entrants that could significantly reduce revenue unless offset by line extensions or new formulations.

3. Which markets present the most growth opportunity for DYMISTA?
Emerging markets in Asia-Pacific, Latin America, and Eastern Europe offer the highest growth potential due to increasing allergy prevalence, expanding healthcare access, and urbanization trends.

4. How does the competitive landscape impact DYMISTA’s pricing power?
Intense competition from generic equivalents and alternative therapies exerts downward pressure on prices, especially in healthcare systems emphasizing cost containment, thereby challenging DYMISTA’s premium positioning.

5. Are there ongoing clinical studies that could influence DYMISTA’s future marketability?
Yes, studies exploring additional indications, pediatric safety, and combination regimens could enhance its application and boost sales, contingent on successful regulatory approvals and positive outcomes.

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Sources:

1. Market Data Forecasts: Allied Market Research, 2022.
2. Clinical Efficacy Studies: Journal of Allergy and Clinical Immunology, 2021.
3. Competitive Analysis Reports: IQVIA, 2022.
4. Sales Data Reports: Mylan (Viatris) Annual Reports, 2021-2022.