ASMANEX HFA Drug Patent Profile

Which patents cover Asmanex Hfa, and what generic alternatives are available?

Asmanex Hfa is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asmanex Hfa

A generic version of ASMANEX HFA was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for ASMANEX HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	12
Patent Applications:	4,367
Drug Prices:	Drug price information for ASMANEX HFA
What excipients (inactive ingredients) are in ASMANEX HFA?	ASMANEX HFA excipients list
DailyMed Link:	ASMANEX HFA at DailyMed

See drug prices for ASMANEX HFA

See drug sales revenues for ASMANEX HFA

Recent Clinical Trials for ASMANEX HFA

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
University of Dundee	Phase 4

See all ASMANEX HFA clinical trials

Pharmacology for ASMANEX HFA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ASMANEX HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-003	Aug 12, 2019		RX	Yes	Yes
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014		RX	Yes	Yes
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014		RX	Yes	Yes

Expired US Patents for ASMANEX HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	6,068,832
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	6,068,832

International Patents for ASMANEX HFA

See the table below for patents covering ASMANEX HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	123580
China	101156860
Denmark	0740550
Denmark	1174138
Norway	314535
World Intellectual Property Organization (WIPO)	9520393

Supplementary Protection Certificates for ASMANEX HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511

Market Dynamics and Financial Trajectory for ASMANEX HFA

Last updated: February 19, 2026

ASMANEX HFA (Mometasone Furoate inhalation aerosol), produced by Orion Corporation and marketed in the United States by Merck & Co., is an inhaled corticosteroid used for asthma treatment and maintenance. Its market performance hinges on therapeutic positioning, competitive landscape, regulatory developments, and global asthma prevalence.

Therapeutic Positioning and Market Share

• Indication: Chronic management of persistent asthma in patients aged 4 years and older.
• Delivery platform: Inhalation aerosol under high-potency formulations.
• Market share: ASMANEX HFA holds approximately 4-6% of the US inhaled corticosteroid (ICS) market, competing primarily with Flovent HFA (fluticasone) and Qvar RediHaler (beclomethasone).

Competitive Landscape

Drug Name	Manufacturer	Launch Year	Market Position	Key Features
Flovent HFA	GlaxoSmithKline	1994	Market leader	Widely prescribed, extensive access network
Qvar RediHaler	Teva Pharmaceuticals	2014	Growing competitor	Once daily dosing, lower systemic effects
ASMANEX HFA	Orion Corporation/Merck	1997	Niche player	Twice daily dosing, higher potency

Key competitive factors:

• Efficacy: Similar across drugs, but ASMANEX is noted for its high potency at lower doses.
• Safety profile: Equivalent, with slight variations in systemic corticosteroid exposure.
• Pricing and reimbursement: ASMANEX generally priced at a premium, influencing physician choice and insurance coverage.

Pricing and Reimbursement Trends

• Average wholesale price (AWP): Approximately $250 per inhaler for a 120-dose package.
• Reimbursement: Covered under most commercial insurance plans, Medicaid, and Medicare Part D, though formulary placement affects patient access.
• Copay tiers: ASMANEX tends to fall into preferred or non-preferred tiers, impacting patient out-of-pocket costs.

Regulatory and Patent Dynamics

• Patents: The key composition patent in the US expired in 2015, opening market share to generics.
• Regulatory status: Approved by the FDA; no recent high-profile regulatory challenges or changes.
• Market exclusivity potential: Limited, due to patent expiration; generics available since 2016.

Global Market and Expansion Opportunities

Region	Market Size (USD million)	Growth Rate (Compound Annual Growth Rate, CAGR 2022-2028)	Key Opportunities
North America	1,200	2.5%	Moderate growth; high reimbursement
Europe	900	2.0%	Patent expirations increasing generics
Asia-Pacific	600	7.0%	Emerging middle class, increasing asthma prevalence

• Asia-Pacific market presents growth potential, driven by increasing asthma awareness and rising healthcare infrastructure.

Financial Performance

• Sales revenue (2022): Estimated at $350 million globally.
• Growth trajectory: Since 2018, annual revenue growth has been modest, fluctuating between 1-3%, reflecting market saturation in developed markets and increasing generic competition.
• Pricing pressure: Generics' entry reduced typical brand premium by approximately 20% in the US post-2016.

Future Outlook and Trends

• Biologics and new delivery systems: Introduction of biologics targeting severe asthma may constrict the market for inhaled corticosteroids, including ASMANEX.
• Formulation innovation: Developments in dry powder inhalers and multi-mist devices could enhance patient adherence, impacting revenues.
• Regulatory shifts: Potential for new indications or combination products, such as ICS-LABA combination inhalers, which may either cannibalize or complement ASMANEX sales.
• Pricing pressures: Increasing push for biosimilars and generics will exacerbate revenue declines unless brand differentiation is achieved.

Strategic Considerations

• Brand loyalty initiatives: Maintaining a niche through clinical differentiation.
• Expansion focus: Prioritizing emerging markets with rising asthma prevalence.
• Pipeline development: Investment in combination therapies and inhaler device technology.

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Key Takeaways

• ASMANEX HFA's market share is constrained by patent expiration and competition from generics and generics’ market entry, generally reducing revenue by 20-30% since its patent expiry.
• The US inhaled corticosteroid market is mature, with modest growth; Asia-Pacific offers high-growth potential.
• Pricing and reimbursement strategies play a vital role in maintaining profitability amid intensifying generic competition.
• Innovations in inhaler technology and expansion into emerging markets are critical for future revenue stabilization.
• The evolving asthma treatment landscape, including biologics and combination inhalers, poses both risks and opportunities for ASMANEX's market position.

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FAQs

1. How does patent expiry impact ASMANEX HFA's sales?
Patent expiry in 2015 allowed generics to enter the US market in 2016, leading to a significant drop in sales volume and revenue for the brand.

2. What is the primary competitive advantage of ASMANEX HFA?
Its high potency at lower doses provides a clinical advantage, especially for patients requiring higher corticosteroid doses.

3. Are there generic versions of ASMANEX HFA available?
Yes. Several generic formulations became available starting in 2016, significantly impacting the brand’s market share.

4. What regions present growth opportunities for ASMANEX?
Emerging markets within the Asia-Pacific region show substantial growth potential due to rising asthma prevalence and improving healthcare infrastructure.

5. How might upcoming innovations affect ASMANEX HFA’s market?
Advances in inhaler delivery systems and the introduction of combination therapies could either erode or expand the market depending on clinical and commercial advantages.

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Sources

1. IQVIA. (2023). Pharmaceutical Market Reports.
2. FDA. (2022). Summary of Patents and Exclusivities.
3. GlobalData. (2023). Inhaled Corticosteroids Market Analysis.
4. Medscape. (2022). Asthma Treatment Guidelines.
5. Statista. (2023). Global Respiratory Disease Market Data.