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.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There is one drug master file entry 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

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	13
Patent Applications:	59
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

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
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 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	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	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731	PA2013023	Lithuania		PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
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
1519731	C20130025 00090	Estonia		PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013

Last updated: July 21, 2026

Dymista (azelastine hydrochloride/fluticasone propionate) market dynamics and financial trajectory (2024–2029)

Executive summary: Dymista is a prescription intranasal combination (azelastine HCl + fluticasone propionate) positioned for allergic rhinitis. Financial trajectory is shaped by (1) generic and therapeutic competition in intranasal corticosteroid (ICS) and antihistamine classes, (2) reimbursement and formulary pull-through for “preferred” intranasal options, and (3) ongoing demand stability in chronic seasonal allergy indications. A precise 2024–2029 revenue forecast cannot be stated without complete, source-backed commercial datapoints (net sales by brand, channel mix, geography, and payer coverage), which are not present in the provided inputs.

What is Dymista’s commercial status and who sells it today?

Dymista (azelastine hydrochloride/fluticasone propionate) is marketed as a fixed-dose intranasal therapy for allergic rhinitis. Its commercial profile is driven by a combination of:

• Targeted symptom control for nasal congestion and rhinorrhea through dual pharmacology (antihistamine + corticosteroid).
• Differentiation versus single-agent intranasal corticosteroids and versus antihistamine-only products.
• Real-world payer behavior that often shifts patients to preferred intranasal corticosteroids and selected combinations after step edits.

Which geographies and channels matter most for Dymista pricing and uptake?

For intranasal allergy franchises, the revenue driver mix usually concentrates in:

• US commercial formularies (tier placement, prior authorization, step therapy).
• Managed care contracting for branded “combination” products versus generics of individual components.
• Retail vs mail order for chronic seasonal use patterns.

How do market dynamics in allergic rhinitis affect Dymista demand?

Allergic rhinitis is a mature market with high prescribing volume and aggressive payer management. Dymista’s demand response is typically most sensitive to:

1. Formulary tiering of intranasal corticosteroids and combination products.
2. Competitor substitution behavior after generic entry of component drugs and availability of alternative fixed-dose combinations.
3. Patient and physician preference for devices, dosing simplicity, and clinician familiarity.

What competitive classes pressure Dymista?

Dymista competes across multiple substitution vectors:

• Single-agent ICS: often preferred due to generic availability and clinical guideline familiarity.
• Fixed-dose ICS/antihistamine combinations: compete on symptom coverage and dosing convenience.
• Antihistamine-only intranasals: compete for congestion/rhinorrhea symptom segments depending on patient phenotype.

How does payer design (PA and step edits) impact Dymista retention?

In allergy, payers commonly:

• Prefer lower-cost ICS options on formulary.
• Use step therapy to require failure or inadequate response on a preferred agent before covering combination therapy.
• Apply prior authorization to higher-cost brands, particularly when generics exist for component molecules.

Net effect is a revenue model that depends on maintaining:

• Clinical positioning (combination efficacy narrative for refractory symptoms).
• Dosing adherence and patient persistence.
• Continued formulary access or negotiated contracting.

What patents protect Dymista and how does exclusivity shape pricing power?

A drug’s market dynamics are anchored to two exclusivity layers:

• Patent exclusivity (composition-of-matter, formulations, device/system features, and method-of-use).
• Regulatory exclusivity and exclusivity-like market protection through data and Orange Book listings (US) or equivalent regimes elsewhere.

However, a correct, litigation-grade mapping of Dymista’s patent estate requires a specific, source-backed Orange Book and patent list. No such list is included in the provided inputs. Under the operating constraints, a complete and accurate patent-expiration timeline cannot be produced.

When does Dymista lose exclusivity, and what generic entry risks exist?

Generic entry risk for combination intranasals usually hinges on:

• Availability of generic versions of both components with the same dosing and formulation.
• Any remaining protectable formulation, method-of-use, or device/pump patents.
• Whether challengers can design around claimed features (particle size, spray characteristics, composition ranges, or dosing regimens).

A precise “lose exclusivity” date and likely generic launch scenarios cannot be stated without the Dymista US Orange Book patent and exclusivity listings and any Paragraph IV history.

What formulations are protected for Dymista, and do device/pump characteristics matter?

For intranasal combination products, formulation protection can cover:

• Specific blend ratios and concentration ranges.
• Excipients that affect spray plume geometry and deposition in the nasal cavity.
• Particle distribution and suspension characteristics.
• Delivery device integration that improves reproducibility of dosing.

Device and formulation protection can influence how easily bios and generics (for small-molecule drugs, “AB-rated” generics) can be substituted and whether they can meet bioequivalence requirements to the reference product.

A detailed mapping of formulation and device claims requires patent numbers and claim scope that are not in the provided inputs.

How does Dymista compare with leading allergic rhinitis alternatives on market performance?

Dymista’s commercial positioning is typically strongest versus:

• Patients inadequately controlled on single-agent therapy.
• Clinicians seeking a single prescription for dual symptom mechanisms.
• Populations with both congestion and rhinorrhea where combination therapy aligns with perceived clinical needs.

Its commercial headwinds include:

• Generic ICS penetration and low-cost substitution at the pharmacy counter.
• Competition from other combination intranasals that may have stronger payer access or lower net costs.
• Broader guideline-based shifts toward preferred stepwise treatment pathways.

A data-backed comparison requires brand-level and competitor net sales, TRx, and share-of-voice metrics that are not present in the provided inputs.

What drives Dymista pricing and reimbursement trends?

Pricing and reimbursement are shaped by:

• Net-to-gross contracting behavior with payers and pharmacy benefit managers.
• Formulary placement and prior authorization strictness.
• Existence of lower-cost generics for component therapies.
• Patient out-of-pocket cost sensitivity, especially under high-deductible insurance plans.

What reimbursement patterns are common for allergy intranasals?

• Preferred tiering often favors generics or therapeutically equivalent preferred agents.
• Combination products frequently sit on non-preferred tiers unless outcomes data or formulary agreements justify coverage.
• Step therapy can reduce switching resistance by requiring use of lower-cost alternatives first.

What is Dymista’s financial trajectory under base-case market conditions (2024–2029)?

A forecastable financial trajectory needs:

• Current annual net sales.
• Channel split (retail vs specialty).
• Prescription trends and net price erosion assumptions.
• Expected generic competitor launches and formulary tightening cycles.

Those datapoints are not included in the provided inputs. Under the constraints, a numeric trajectory or revenue forecast cannot be produced.

How does patent litigation and FDA review affect Dymista’s commercial outlook?

In the intranasal small-molecule category, commercial swings most often occur due to:

• Paragraph IV challenges and settlement-driven “authorized generic” entries.
• Court injunctions that delay generic launch (and thus preserve revenue temporarily).
• FDA approvals that expand generic supply quickly, compressing net prices.

A litigation and FDA review timeline for Dymista cannot be provided without the underlying case docket, FDA approval records, and patent challenge history.

What Orange Book status does Dymista have, and what does it mean for exclusivity?

Orange Book status is decisive for generic entry risk:

• Listed patents tied to approval and exclusivity (including those still “in force”).
• Expiration and carve-outs that determine when ANDA applicants can file and when generics can launch.
• Pediatric exclusivity and other regulatory exclusivities that extend effective market protection.

No Orange Book listing details are included in the provided inputs, so an accurate status summary cannot be stated.

What business scenarios determine Dymista’s next 12 to 36 months revenue?

For an established branded allergy intranasal, the near-term business envelope typically depends on four measurable factors:

1. Formulary changes: tier shifts or PA expansion.
2. Net price erosion: contracting and switching pressures after competitor actions.
3. Utilization: TRx and persistence patterns during peak allergy seasons.
4. Competitive substitution: uptake of other combination products and preferred generics.

A scenario matrix with quantified impacts cannot be created without current base metrics (net sales and TRx trends).

Key tables for decision makers (revenue drivers and risks)

Table: Primary revenue drivers for Dymista

Driver	Why it matters	What to monitor
Formulary placement	Determines whether patients can access the brand without step edits	Payer tier changes, PA/step policy updates
Relative net price	Drives PBM contracting and pharmacy uptake vs generics	Net price vs class; rebate and discount movements
Competitive substitution	Moves TRx when cheaper options are covered	Share shifts vs leading ICS and combination options
Seasonality and persistence	Allergy demand is seasonal but repeat use supports stability	Peak season TRx; refill and switch rates
Device/user experience	Affects adherence and persistence	Patient reported outcomes and adherence proxies

Table: Main downside risks

Risk	Mechanism	Commercial impact channel
Generic entry or deeper substitution	Lower-cost alternatives displace combination brand	TRx decline and net price compression
Steeper payer restrictions	Step therapy reduces brand starts	Reduced initiation and slower conversion
Competitor contract wins	Competitor becomes preferred in payer networks	Share loss at pharmacies

Key Takeaways

• Dymista’s market dynamics are dominated by payer-managed substitution in allergic rhinitis, where generic ICS options and step-therapy structures can limit branded combination uptake.
• Financial trajectory depends more on formulary access, net contracting, and patient persistence than on incremental clinical differentiation alone.
• A quantified 2024–2029 revenue and market-share trajectory requires brand net sales, TRx trends, competitor launch events, and Orange Book/patent timelines; those source details are not present in the provided inputs.

FAQs

1. How do formulary step edits typically affect intranasal combination brands like Dymista?
2. What competitive factors most often cause TRx switching from Dymista to preferred intranasal corticosteroids?
3. How do net price and rebate structures influence Dymista’s profitability even when prescription demand is stable?
4. What Orange Book listings and patent categories most determine generic launch timing for intranasal fixed-dose combinations?
5. What indicators (TRx, persistence, PA rates) best predict Dymista revenue momentum into the next allergy season?

References

No sources were provided in the prompt, and no cited materials are included.

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