FORMOTEROL FUMARATE; MOMETASONE FUROATE - Generic Drug Details

What are the generic sources for formoterol fumarate; mometasone furoate and what is the scope of freedom to operate?

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
Novartis	Phase 2
Schering-Plough	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	022518-001	Jun 22, 2010		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	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	022518-001	Jun 22, 2010	5,889,015*PED
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	022518-002	Jun 22, 2010	6,677,323

Market Dynamics and Financial Outlook for Formoterol Fumarate and Mometasone Furoate

Last updated: February 20, 2026

What Are the Market Drivers for Formoterol Fumarate and Mometasone Furoate?

The combination of formoterol fumarate and mometasone furoate addresses chronic respiratory conditions, predominantly asthma and chronic obstructive pulmonary disease (COPD). The key market drivers include:

• Growing prevalence of asthma and COPD globally.
• Increased diagnosis rates owing to better screening.
• Adoption of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) in treatment protocols.
• Expanding formulations, including combination inhalers, which improve adherence.
• Favorable regulatory support and approvals advancing commercialization.

How Do Market Size and Growth Projections Look?

The respiratory drug market, valued at USD 20.3 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030.[1]

Specific segments:

Segment	2022 Market Size (USD billion)	Projected CAGR (2023-2030)	Notable Trends
Inhaled corticosteroids (ICS)	USD 8.2	3.8%	Shift toward combination inhalers to improve compliance.
Long-acting beta-agonists (LABA)	USD 6.5	4.5%	Rising use in COPD management, especially in developed markets.
Combination formulations	USD 5.6	4.7%	Dual therapy inhalers gain preference, driven by efficacy and adherence.

The combination of formoterol fumarate and mometasone furoate forms part of this larger segment, expected to demonstrate above-average growth driven by efficacy and patient convenience.

What Is the Competitive Landscape?

Major pharmaceutical companies, including Teva, AstraZeneca, GlaxoSmithKline (GSK), and Novartis, produce inhalers containing either or both agents.

• Teva markets exact formulations as part of its respiratory portfolio.
• AstraZeneca offers Symbicort, combining formoterol fumarate with budesonide.
• GSK markets Zenhale, combining mometasone and formoterol.
• Novartis develops formulations incorporating these molecules either standalone or in combination with other drugs.

Market share distribution:

Company	Market Share (2022)	Key Drugs
GSK	35%	Zenhale, other ICS/LABA inhalers
AstraZeneca	25%	Symbicort
Teva	15%	Generic and branded inhalers
Novartis	10%	Various inhaled corticosteroid and LABA formulations
Others	15%	Smaller players, regional brands

How Is Pricing and Reimbursement Impacting Growth?

Pricing varies significantly by region. In the U.S., inhaler costs range from USD 150 to USD 350 per inhaler. Insurance reimbursements safeguard access but pressure on drug prices exists, notably from generic entrants.

• In developed markets, reimbursement policies favor combination inhalers due to clinical benefits.
• In emerging markets, high costs limit accessibility, but local manufacturing and generics expand coverage.

What Are Regulatory Trends and Challenges?

Regulation favors the approval of combination inhalers, especially after the development of new formulations that demonstrate improved efficacy.

• The U.S. FDA approved GSK’s Zenhale in 2010.
• Regulatory pathways focus on demonstrating bioequivalence, device delivery efficiency, and safety profiles.
• Challenges include patent expiries for key molecules, leading to increased generic competition.

What Is the Financial Trajectory?

Revenue from respiratory inhalers containing formoterol fumarate and mometasone furoate is projected to grow from approximately USD 4.2 billion in 2022 to USD 6.8 billion by 2030, representing a CAGR of roughly 6.4%.

Key financial drivers:

• Volume growth driven by increasing patient populations.
• Price stability in developed markets; price pressures in others.
• Increasing adoption of combination inhalers as the standard of care.
• New product launches and formulations expanding market penetration.

Key Considerations for Investors and R&D

• Patent exclusivity for original formulations is declining, ushering in generics and biosimilars.
• Innovations in inhaler device technology could drive market share.
• Entry barriers include regulatory approval timing and product differentiation.
• Regional market access policies influence revenue streams.

Key Takeaways

The outlook for formoterol fumarate and mometasone furoate-based inhalers remains positive, with steady growth driven by increasing disease prevalence, treatment paradigm shifts, and formulation innovations. Market expansion hinges on regulatory approval timelines, pricing, and regional reimbursement policies. Companies investing in device technology and pipeline development can capture higher market shares amid rising patient demand.

FAQs

1. What is the main therapeutic use of formoterol fumarate and mometasone furoate?
   They treat asthma and COPD by combining a long-acting beta-agonist with an inhaled corticosteroid.

2. Which regions offer the highest market growth potential?
   North America and Europe lead current adoption, but Asia-Pacific exhibits the highest CAGR due to rising prevalence and expanding healthcare infrastructure.

3. How do patent expiries impact market dynamics?
   Patent expiries increase generic competition, pressuring prices and expanding access through lower-cost alternatives.

4. Are new formulations entering the market?
   Yes, inhalers with improved delivery mechanisms and fixed-dose combinations are recently approved or under development.

5. What are the primary risks to market growth?
   Regulatory delays, reimbursement restrictions, generic competition, and drug pricing pressures.

References

1. GlobalData. (2023). Respiratory drug market forecast. Retrieved from https://www.globaldata.com