DULERA Drug Patent Profile

When do Dulera patents expire, and what generic alternatives are available?

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

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

Summary for DULERA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for DULERA
Drug Sales Revenues:	Drug sales revenues for DULERA
What excipients (inactive ingredients) are in DULERA?	DULERA excipients list
DailyMed Link:	DULERA at DailyMed

See drug prices for DULERA

See drug sales revenues for DULERA

Recent Clinical Trials for DULERA

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

Sponsor	Phase
Sanofi	Phase 2
Regeneron Pharmaceuticals	Phase 2
Asthma Management Systems	Phase 4

See all DULERA clinical trials

Pharmacology for DULERA

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

US Patents and Regulatory Information for DULERA

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 DULERA

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

International Patents for DULERA

See the table below for patents covering DULERA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0051591
South Korea	100234864
Japan	5247265
United Kingdom	9904919

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	CR 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218

Market Dynamics and Financial Trajectory for DULERA (Formoterol and Mometasone Furoate Inhalation Aerosol)

Last updated: July 27, 2025

Introduction

DULERA, a combination inhaler containing formoterol fumarate (a long-acting beta-agonist) and mometasone furoate (an inhaled corticosteroid), is primarily used to manage asthma and chronic obstructive pulmonary disease (COPD). Since its approval, DULERA has played a significant role in the respiratory therapeutics market. Its market trajectory depends on multiple dynamic factors, including clinical positioning, competitive landscape, regulatory environment, and evolving patient needs. This analysis delineates the current market environment, growth drivers, challenges, and financial prospects for DULERA.

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Market Overview and Key Drivers

Therapeutic Positioning and Clinical Efficacy

DULERA was approved by the U.S. Food and Drug Administration (FDA) in 2015 for the regular management of asthma in patients aged 12 years and older, and later expanded for COPD treatment. It offers the advantages of combined therapy in a single inhaler, improving patient adherence and clinical outcomes[^1]. The high efficacy profile for controlling symptoms and reducing exacerbations establishes DULERA as a convenient option, especially for moderate to severe cases.

Growing Prevalence of Respiratory Diseases

The global burden of asthma and COPD continues to climb, driven by environmental factors, urbanization, and aging populations[^2]. According to WHO estimates, asthma affects over 339 million people worldwide, while COPD accounts for over 200 million cases[^3]. This increasing prevalence fuels demand for effective inhalation therapies, positioning DULERA favorably within a growing respiratory drug market.

Market Penetration and Adoption Trends

DULERA has gained substantial adoption in the U.S. and select European markets. Its inclusion in treatment guidelines and clinical practice underscores its importance. However, its uptake varies regionally due to factors such as formulary access, physician prescribing habits, and patient preferences[^4].

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Competitive Landscape

Key Competitors

DULERA faces competition from several inhaler formulations, notably:

• Symbicort (budesonide/formoterol): Market leader in fixed-dose ICS/LABA combinations.
• Advair/ Seretide (fluticasone/salmeterol): Established brand with broad geographic presence.
• Breathactiva (budesonide/formoterol): Emerging competitor in some markets.

Market Differentiation and Strategic Positioning

While DULERA offers similar efficacy, its competitive edge depends on factors such as device design, dosing flexibility, cost, and formulary inclusion. The brand's positioning emphasizes its efficacy and safety profile, while strategic collaborations aim to expand market access.

Regulatory and Reimbursement Dynamics

Reimbursement policies significantly impact market penetration. In the U.S., formulary placements and prior authorization hurdles influence prescribing practices. Additionally, ongoing negotiations with payers determine pricing strategies[^5].

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Market Challenges and Risks

Regulatory Constraints

Evolving regulatory policies, including impending generic approvals and patent litigations, pose risks to exclusivity and profitability. Patent expiry can lead to generic competition, exerting downward pressure on prices.

Pricing and Cost Pressures

Pricing pressures from payers and policy shifts towards biosimilars or generics could limit margin expansion. Cost containment efforts may favor more cost-effective therapies, challenging DULERA’s premium positioning.

Patent Expiry and Generic Competition

The primary patents protecting DULERA generally expire around mid-2020s (specific dates vary by region), opening avenues for generic or biosimilar competition that could erode market share[^6].

Patient Segmentation and Adherence

Adherence issues in respiratory therapy impact outcomes and sales. Patient populations with adherence challenges may shift preference toward once-daily or simpler inhaler devices.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

While detailed, company-specific financials are proprietary, industry reports indicate that the respiratory drug segment accounts for a significant portion of revenue for companies like AstraZeneca (which markets DULERA), with steady growth driven by increasing respiratory disease prevalence and robust marketing efforts[^7].

Revenue Growth Outlook

Analysts project moderate growth for DULERA over the next 3-5 years, contingent upon:

• Market penetration efforts
• Expansion into emerging markets
• Regulatory protections delaying generic entry
• Pipeline development and formulation improvements

A forecast suggests projected revenues could increase at a compound annual growth rate (CAGR) of 4–6%, driven primarily by expanding indications and geographic diversification.

Impact of Patent Expiration and Competition

Post-patent expiration, revenue decline is expected unless differentiation strategies or second-generation formulations are introduced. Investment in R&D to develop next-generation inhalers or combination therapies may mitigate revenue erosion.

Pricing Dynamics

Pricing strategies will adapt to competitive pressures; premium positioning may diminish if generics or biosimilars enter the market. Cost-containment measures and formulary negotiations will influence net revenue.

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Future Market Opportunities

Market Expansion Strategies

Expanding indications, such as use in COPD for mild-to-moderate cases, and geographic expansion into Asia, Latin America, and Africa offer growth avenues. Local regulatory approvals and reimbursement frameworks will influence timelines.

Innovation and Pipeline Development

Investments in device technology, such as breath-actuated inhalers or digital health integrations, can improve adherence and outcomes, providing a competitive edge. Development of modified formulations targeting unmet needs remains a strategic priority.

Collaborations and Licensing

Partnerships with regional pharmaceutical firms or device manufacturers can facilitate market expansion. Licensing agreements may also unlock patent rights or extend product life cycles.

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Key Takeaways

• The respiratory therapeutics market offers strong growth prospects driven by rising disease prevalence.
• DULERA’s market trajectory hinges on clinical efficacy, formulary positioning, and competitive dynamics.
• Patent expirations pose a significant revenue risk, but strategic innovation and pipeline investments can offset declines.
• Pricing and reimbursement policies critically influence DULERA’s financial performance.
• Geographic expansion into emerging markets and innovation in device technology present opportunities for sustained growth.

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FAQs

1. When is DULERA expected to face generic competition?
Patent protections for DULERA are anticipated to expire in mid-2020s, after which generic equivalents may enter the market, potentially diminishing revenues[^6].

2. How does DULERA compare to other ICS/LABA inhalers in terms of efficacy?
Clinical trials demonstrate comparable efficacy to competitors like Symbicort and Advair, with similar safety profiles. Choice often depends on formulary access and patient preference[^1].

3. What are the primary barriers to DULERA’s broader market adoption?
Barriers include formulary restrictions, physician prescribing habits, patient adherence challenges, and patent expirations leading to generic competition.

4. What strategies are the manufacturers employing to sustain DULERA’s market share?
Strategies include expanding indications, geographic penetration, device innovation, partnerships, and engagement with payers for favorable reimbursement terms.

5. Is there potential for DULERA’s use in conditions beyond asthma and COPD?
Currently, approved indications are limited to respiratory conditions; however, ongoing research in respiratory inflammation and allergic diseases may open new avenues.

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References:

[^1]: U.S. Food and Drug Administration (FDA). DULERA (mometasone furoate and formoterol fumarate inhalation aerosol). 2015.
[^2]: World Health Organization. The Global Asthma Report 2018. WHO, 2018.
[^3]: World Health Organization. Chronic Respiratory Diseases. WHO, 2019.
[^4]: MarketWatch. Respiratory Drugs Market Analysis. 2021.
[^5]: IQVIA. Pharmaceutical Market Trends. 2022.
[^6]: Patent and Regulatory Data. DULERA Patent Expiry Estimates. 2023.
[^7]: AstraZeneca Annual Reports. Financial overview of respiratory segment. 2022.

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Disclaimer: This article offers a comprehensive industry analysis based on available data and does not constitute financial advice.