Formoterol fumarate; mometasone furoate - Generic Drug Details

What are the generic drug sources for formoterol fumarate; mometasone furoate and what is the scope of patent protection?

Formoterol fumarate; mometasone furoate is the generic ingredient in one branded drug marketed by Organon Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for formoterol fumarate; mometasone furoate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	15
DailyMed Link:	formoterol fumarate; mometasone furoate at DailyMed

Recent Clinical Trials for formoterol fumarate; mometasone furoate

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
Schering-Plough	Phase 2
Novartis	Phase 2

See all formoterol fumarate; mometasone furoate clinical trials

Pharmacology for formoterol fumarate; mometasone furoate

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate; mometasone furoate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for formoterol fumarate; mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-003	Aug 12, 2019		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes

Expired US Patents for formoterol fumarate; mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	5,889,015*PED
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	5,889,015*PED
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	6,068,832
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	6,057,307*PED
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	6,677,323
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	6,068,832

Market Dynamics and Financial Trajectory for Formoterol Fumarate and Mometasone Furoate

Last updated: July 27, 2025

Introduction

The pharmaceuticals landscape demonstrates evolving dynamics driven by technological innovations, regulatory changes, and shifting patient needs. Two prominent inhalation therapies, formoterol fumarate and mometasone furoate, play important roles within respiratory disease management, particularly asthma and chronic obstructive pulmonary disease (COPD). This analysis examines their market dynamics, competitive positioning, and anticipated financial trajectories amidst contemporary industry trends.

---

Market Overview: Formoterol Fumarate and Mometasone Furoate

Formoterol fumarate, a long-acting beta-agonist (LABA), provides sustained bronchodilation, predominantly prescribed for asthma and COPD maintenance therapy. Mometasone furoate, a potent corticosteroid, reduces airway inflammation, often combined with LABAs to enhance efficacy.

The convergence of these agents in fixed-dose combination inhalers underpins a growing segment, driven by the need for enhanced adherence and improved clinical outcomes. Markets are also witnessing an increased regulatory emphasis on safety profiles, especially in product approvals and label extensions.

---

Market Drivers and Influences

• Epidemiological Burden: The rising prevalence of asthma and COPD globally fuels demand. According to WHO, over 300 million people suffer from asthma and COPD collectively, pushing markets toward expanded inhaler utilization [1].

• Healthcare Infrastructure Expansion: Emerging markets with improving healthcare infrastructure open new avenues for inhalation therapies, especially as awareness and diagnostic rates increase.

• Product Innovation and Formulation Advances: Technological innovations such as dry powder inhalers (DPIs) and metered-dose inhalers (MDIs) enhance user convenience. Companies invest heavily in developing combination products incorporating formoterol fumarate and mometasone furoate for superior efficacy and safety.

• Regulatory and Reimbursement Dynamics: Clearances from bodies like the FDA and EMA, coupled with reimbursement policies, directly influence market success. Recent approvals of novel combinations and label expansions broaden market access.

• Competitive Landscape and Patent Expirations: Patent expirations of key brands create opportunities for generics to penetrate markets, compress pricing, and reshape profit pools. Conversely, patent extensions through formulation patents sustain exclusivity for innovative therapies.

---

Competitive Positioning

Major market players include AstraZeneca, GlaxoSmithKline (GSK), and Teva Pharmaceuticals. Notably, GSK’s popular inhalers like Advair (fluticasone/salmeterol) has set a precedent, while combinations with mometasone furoate, such as Dulera, have gained traction.

The increasing prevalence of generic versions post-patent expiration intensifies price competition and profitability pressures. Nonetheless, premium brands maintain market share via differentiation, safety profiles, and patient compliance features.

---

Financial Trajectory Analysis

Revenue Growth Projections

The inhalation segment for formoterol fumarate and mometasone furoate is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, driven by expanding patient populations and rising adoption of combination therapies [2]. The market is expected to surpass USD 8 billion by 2028, from an estimated USD 4.5 billion in 2022.

Influencing Factors

• Patents and Exclusivity: Scheduled patent expirations for some key formulations between 2023 and 2026 could cause revenue dips but also stimulate market entry of generics and biosimilars, fragmenting the revenue base.

• Regulatory Approvals: Approvals for new delivery mechanisms or enhanced formulations (e.g., environmentally friendly inhalers) could invigorate sales.

• Pricing Strategies: Premium pricing supported by clinical benefits sustains margins for innovators, though currency fluctuations and pricing regulation exert downward pressure in emerging markets.

Cost of Development

Development expenditures for new inhalation therapies remain high, with clinical trials, regulatory filings, and manufacturing validations requiring investments exceeding USD 200 million per pipeline asset. Companies focus on securing robust patent protections and lifecycle management strategies to ensure sustained revenue streams.

Market Risks

• Patent Cliff and Generic Competition: The expiry of key patents precipitates revenue erosion unless effective brand differentiation or new formulations are introduced.

• Regulatory Hurdles: Stringent approval processes for combination therapies demand rigorous demonstrating of safety and efficacy, extending timelines and elevating costs.

• Physician and Patient Acceptance: Clinical preference shifts and patient adherence influence sales; formulations that improve ease of use are favored.

---

Emerging Trends Impacting Market and Financial Outlook

• Electronic and Digital Integration: Smart inhalers equipped with sensors and connectivity features enhance adherence monitoring, potentially commanding premium pricing and offering new revenue avenues.

• Personalized Medicine Approaches: Pharmacogenomics and targeted therapies could refine selection criteria, optimizing outcomes and supporting premium pricing models.

• Sustainability Focus: Environmental concerns catalyze the development of eco-friendly inhalers, potentially increasing R&D costs but appealing to environmentally conscious markets.

---

Regulatory Landscape and Future Outlook

Regulatory agencies are intensifying scrutiny on safety, especially regarding cardiovascular risks associated with LABAs and inhaled corticosteroids. This may influence product labeling and market access strategies. Additionally, accelerated approval pathways and priority review designations for innovative formulations are likely to expedite market entry and revenue realization.

Opportunities

• Launch of fixed-dose combinations (FDCs) with improved safety and efficacy profiles.
• Expansion into untapped markets through strategic licensing and partnerships.
• Leveraging digital health for adherence and outcomes tracking.

Threats

• Patent expirations leading to generic substitution.
• Price regulation pressures, notably in public healthcare systems.
• Competitive innovations diminishing market share of existing products.

---

Key Takeaways

• The combination of formoterol fumarate and mometasone furoate is positioned for steady growth, supported by increasing respiratory disease prevalence and technological innovations.
• Patent expirations necessitate strategic lifecycle management, including developing new formulations and digital health integrations.
• Competitive pressures from generics and biosimilars will drive downward pricing, but innovation and brand differentiation can sustain margins.
• Emerging markets present significant growth opportunities, contingent on regulatory developments and healthcare infrastructure improvements.
• Future profitability hinges on regulatory agility, product innovation, and strategic alliances within the evolving landscape.

---

FAQs

1. What is the primary therapeutic role of formoterol fumarate and mometasone furoate?
   Formoterol fumarate acts as a long-acting bronchodilator, while mometasone furoate reduces airway inflammation; together, they are used in combination inhalers for managing asthma and COPD.

2. How will patent expirations impact the market?
   Patent expirations open markets to generics, reducing brand revenues, but also create opportunities for biosimilars and new formulations to capture market share.

3. What are the main growth drivers for these inhalation therapies?
   Rising respiratory disease prevalence, healthcare infrastructure expansion, product innovation, and patient adherence improvements are key drivers.

4. What regulatory trends influence future market trajectories?
   Increased safety requirements, accelerated approval pathways for innovative delivery systems, and environmental regulations for inhaler devices shape market access and revenue potential.

5. Which regions offer the most promise for growth in this sector?
   Emerging markets, including Asia-Pacific and Latin America, due to increasing disease burden and expanding healthcare access, are poised for significant growth.

---

Sources

[1] World Health Organization. (2021). Global Surveillance, Prevention and Control of Chronic Respiratory Diseases.
[2] Fortune Business Insights. (2022). Inhalers Market Size, Share & COVID-19 Impact Analysis.
[3] Grand View Research. (2022). Respiratory Devices Market Size, Trends and Forecasts.