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-six 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:	4,642
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	205641-002	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014

International Patents for ASMANEX HFA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69526425
European Patent Office	1174139	Utilisation du furoate de mometasone pour le traitement des affections pulmonaires et des voies respiratoires (Use of mometasone furoate for treating airway passage and lung diseases)
Hungary	227837	USE OF MOMETASONE FUROATE FOR THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OR AIRWAY PASSAGE AND LUNG DISEASES

Supplementary Protection Certificates for ASMANEX HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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
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

Market Dynamics and Financial Trajectory for ASMANEX HFA

Last updated: October 6, 2025

Introduction

ASMANEX HFA (mometasone furoate) inhalation aerosol, developed by AstraZeneca, is a glucocorticoid used primarily for the management of asthma and allergic rhinitis. Since its approval, ASMANEX HFA has established a significant presence within the respiratory therapeutics sector. This analysis explores the market dynamics shaping its growth, its financial trajectory, and future potential within the overused and evolving respiratory drug landscape.

Market Overview

The global respiratory drug market, valued at approximately $43 billion in 2022, projects a Compound Annual Growth Rate (CAGR) of 4.8% from 2023 to 2030. The increasing prevalence of asthma and allergic rhinitis—as reported by the World Health Organization—fuels consistent demand. Notably, asthma affects over 262 million individuals worldwide, underscoring the sustained medical need for effective corticosteroids like ASMANEX HFA.

Product Profile and Positioning

ASMANEX HFA delivers mometasone furoate via hydrofluoroalkane (HFA) inhalation, marked by enhanced formulation stability and targeted pulmonary delivery. Its once-daily dosing and reduced systemic absorption compared to older corticosteroids position it favorably among clinicians seeking efficacy with minimized side effects.

Key Differentiators:

• Efficacy in controlling persistent asthma
• Reduced oropharyngeal adverse events
• Convenient inhalation device

The drug's labeling and clinical data reinforce its safety profile, supporting strong prescribing habits.

Driving Market Dynamics

1. Rising Global Asthma Prevalence

The persistent increase in asthma cases globally propels demand for inhaled corticosteroids (ICS) such as ASMANEX HFA. Urbanization, pollution, and lifestyle shifts contribute to increased respiratory conditions, particularly in emerging markets.

2. Competitive Landscape and Product Portfolio

ASMANEX HFA primarily competes with inhaled corticosteroids like Fluticasone (Flovent), Beclomethasone (QVAR), and newer combination therapies (ICS/LABA). The shift toward combination inhalers, such as Advair and Symbicort, impacts monotherapy sales. However, monotherapy remains critical for initial and mild asthma cases, supporting steady sales of ASMANEX HFA.

3. Regulatory and Reimbursement Policies

Stringent regulatory standards influence market access. AstraZeneca’s proactive regulatory positioning, including approvals in emerging markets, bolsters its market share. Reimbursement policies favorably impact prescription volumes, particularly where corticosteroid inhalers are deemed essential medications.

4. Igniting Impact of Biosimilars and Generic Competition

While no biosimilars directly target ASMANEX HFA, generic corticosteroids threaten price competition. Patent expirations scheduled throughout the 2020s could introduce generics, potentially reducing prices and margins.

5. Innovation and Line Extension Strategies

AstraZeneca’s pipeline investments aim to enhance formulations (e.g., combination products) and delivery mechanisms, which could extend the product’s life cycle. Investment in digital inhaler solutions and telemetry-enabled devices aligns with evolving patient engagement trends.

Financial Trajectory Analysis

Historical Performance

Since its market introduction, ASMANEX HFA has exhibited consistent revenue generation, with global sales exceeding $300 million in 2022. Geographic diversification accounts for about 60% of sales in North America and Europe, with remaining revenues from Asia-Pacific and Latin America.

Key financial indicators:

• Stable gross margins of approximately 70%
• Moderate R&D investments to maintain competitive edge
• Consistent patent protections until approximately 2030

Forecasted Growth and Challenges

Projected CAGR for ASMANEX HFA sales hovers around 3-4% through 2030, driven primarily by expanding markets and evolving prescribing habits.

Growth Drivers:

• Increased prevalence of asthma and allergic rhinitis
• Expansion into emerging markets with rising healthcare infrastructure
• Product line extensions, including combination therapies

Challenges:

• Potential price erosion from generics post-patent expiry
• Competitive pressures from newer biologics and combination inhalers
• Regulatory hurdles affecting product adaptations

Emerging Trends Influencing Financial Trajectory

Digital health integration, like inhaler telemetry, promises improved adherence—potentially boosting sales. Moreover, increasing adoption of personalized medicine and targeted therapies could favor combination products, prompting AstraZeneca to prioritize such innovations.

Market Risks and Opportunities

Risks:

• Patent cliffs and associated generic entries decreasing prices
• Market saturation in developed countries
• Regulatory changes potentially restricting inhaler approvals or reimbursements

Opportunities:

• Growing markets in Asia-Pacific and Latin America
• Expansion into pediatric populations with tailored formulations
• Development of inhaler device improvements that enhance patient adherence

Strategic Outlook

AstraZeneca’s strategic focus on pipeline expansion, embracing digital health, and geographic diversification establish a resilient framework for ASMANEX HFA’s sustained financial contribution. Its strength lies in its established safety profile, differentiating features, and adaptability to emerging respiratory therapy trends.

Key Takeaways

• The respiratory drug market's growth, driven by rising asthma prevalence and unmet needs in emerging markets, presents a favorable environment for ASMANEX HFA.
• Competitive pressures from combination therapies and potential generic entry pose risks but are mitigated through product differentiation and pipeline innovation.
• Geographic expansion remains crucial; increasing adoption in Asia-Pacific and Latin America could significantly augment revenues.
• Innovations in digital inhaler technology and personalized treatment modalities could enhance patient adherence and therapeutic outcomes, indirectly supporting financial growth.
• Vigilance on patent expiries and regulatory changes is essential for strategic planning; proactive lifecycle management will determine ongoing profitability.

FAQs

1. What is the primary therapeutic advantage of ASMANEX HFA over competing inhaled corticosteroids?
ASMANEX HFA offers a once-daily dosing regimen with a well-established safety and efficacy profile, along with reduced systemic absorption, making it suitable for persistent asthma management.

2. How might patent expiration impact ASMANEX HFA’s market share?
Patent expiry could lead to generic competition, exerting downward pressure on prices and margins. Strategic formulations and pipeline developments aim to offset these impacts.

3. What growth opportunities exist in emerging markets?
Expanding healthcare infrastructure, increasing disease awareness, and regulatory approvals facilitate market entry and growth in Asia-Pacific, Latin America, and Africa.

4. How does digital health influence the future of ASMANEX HFA?
Integration of telemetry-enabled inhalers can improve adherence, track usage, and provide real-world data, which could enhance patient outcomes and support premium pricing strategies.

5. What role does pipeline development play in the product’s future?
Pipeline investments in combination therapies and device innovations aim to extend life cycle, improve therapeutic efficacy, and maintain competitive positioning.

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Sources:
[1] Global Respiratory Disease Market Report, 2022.
[2] WHO Asthma Fact Sheet.
[3] AstraZeneca Annual Reports, 2022.
[4] MarketResearch.com, Respiratory Drugs Segment Analysis, 2023.
[5] Regulatory Affairs Reports, 2023.