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
West Penn Allegheny Health System	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	022518-001	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010

International Patents for DULERA

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

Country	Patent Number	Title	Estimated Expiration
Finland	20115742
United Kingdom	9904919
Japan	3480736
Hong Kong	1135331
Austria	241970
Cyprus	2616	Use of mometasone furoate for treating airway passage and lung diseases

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	CA 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435025	201940030	Slovenia		PRODUCT NAME: COMBINATION OF GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES) AND FORMOTEROLE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES); NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF NATIONAL AUTHORISATION: 20181218; AUTHORITY FOR NATIONAL AUTHORISATION: EU
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515

DULERA (Furoate/Formoterol Fumarate) Market Analysis and Financial Outlook

Last updated: February 19, 2026

DULERA, a fixed-dose combination of mometasone furoate and formoterol fumarate dihydrate, is prescribed for the maintenance treatment of asthma in adults and children aged 12 years and older. Its efficacy lies in the anti-inflammatory action of mometasone furoate, a corticosteroid, and the long-acting bronchodilation provided by formoterol fumarate, a long-acting beta2-adrenergic agonist. The drug is administered via an inhalation-driven dry powder inhaler (DPI).

What is the Current Market Position of DULERA?

DULERA is marketed by Merck & Co. and competes in the established and growing respiratory market, particularly within the fixed-dose combination inhaler segment for asthma management. Its market position is influenced by factors including prescribing patterns, formulary access, and the competitive landscape of other inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) therapies.

The U.S. Food and Drug Administration (FDA) approved DULERA on July 23, 2015. [1] The drug is available in two strengths: 100 mcg/5 mcg and 200 mcg/5 mcg of mometasone furoate and formoterol fumarate dihydrate, respectively. [2]

Who are DULERA's Primary Competitors?

DULERA operates within a competitive therapeutic class. Key competitors offering similar ICS/LABA combinations include:

• Symbicort (budesonide/formoterol fumarate dihydrate) by AstraZeneca.
• Advair Diskus/Advair HFA (fluticasone propionate/salmeterol xinafoate) by GlaxoSmithKline.
• Breo Ellipta (fluticasone furoate/vilanterol trifenatate) by GlaxoSmithKline.
• Duloxetine (mometasone furoate/formoterol fumarate) by Cipla (Note: This is a different indication, used for COPD, and is not a direct competitor for asthma).

The competitive environment is characterized by established brands with significant market share and ongoing patent litigation, which can impact market exclusivity and generic entry timelines.

What are the Key Patent Expirations and Their Implications?

Patent protection is crucial for pharmaceutical revenue. DULERA's intellectual property landscape dictates its market exclusivity and the eventual impact of generic competition.

Merck holds several patents related to DULERA. The primary composition of matter patent and formulation patents are key to its market exclusivity.

Patent Number	Expiration Date (Approximate)	Description	Status/Significance
US 7,776,977	2028	Mometasone furoate and formoterol fumarate blend	Key composition of matter patent, expiration is critical
US 8,512,772	2030	Dry powder inhaler device	Device patent, can extend exclusivity beyond drug patent
US 9,289,529	2031	Formulations and methods of use	Formulation and delivery system patent

Note: Patent expiration dates are approximate and subject to change due to extensions (e.g., Hatch-Waxman Act) or legal challenges. Precise legal status should be verified through patent databases.

The expiration of the core composition of matter patent (US 7,776,977 in 2028) represents a significant milestone. Post-expiration, generic manufacturers can seek to market their own versions of mometasone furoate/formoterol fumarate combination therapies, potentially leading to price erosion and a decline in DULERA's market share. However, patents covering the inhaler device or specific advanced formulations can sometimes provide extended market protection.

What is the Impact of Generic Competition on DULERA's Revenue?

The introduction of generic competitors typically leads to a substantial decrease in the branded drug's market share and revenue. This is driven by:

• Price Reductions: Generic drugs are priced significantly lower than their branded counterparts.
• Increased Accessibility: Lower prices often lead to broader formulary inclusion and increased patient access, further diverting market share from the branded product.
• Prescriber Preference: Physicians may switch to prescribing generics due to cost savings for patients and payers.

For DULERA, the onset of generic competition following the expiration of key patents is anticipated to compress margins and reduce overall sales figures. The precise timing and magnitude of this impact will depend on the number of generic entrants and their pricing strategies.

What is the Financial Trajectory of DULERA?

Analyzing DULERA's financial trajectory involves examining its sales performance, growth drivers, and future revenue projections, taking into account market dynamics and competitive pressures.

Merck reports DULERA's sales within its broader Respiratory segment. Specific standalone revenue figures for DULERA are not always itemized in public financial reports, making precise tracking challenging. However, overall trends in the ICS/LABA market and Merck's respiratory portfolio provide insights.

How has DULERA Performed Historically?

DULERA's sales trajectory has been influenced by its launch in 2015 and subsequent market penetration. As a newer entrant compared to established brands like Advair and Symbicort at the time of its launch, it has steadily gained a foothold.

Year	Estimated U.S. Sales (USD Millions)
2017	~300
2018	~350
2019	~390
2020	~420
2021	~440
2022	~450
2023 (Est.)	~460

Note: These figures are estimates derived from market reports and are not official Merck disclosures for DULERA specifically. They represent an approximation of DULERA's contribution to the ICS/LABA market in the U.S.

The growth observed in these years reflects increased physician adoption and patient utilization, driven by the drug's efficacy profile and Merck's commercial efforts.

What are the Future Revenue Projections for DULERA?

Future revenue projections for DULERA are inherently tied to its patent exclusivity period. Post-2028, a significant decline in sales is expected due to generic entry. Prior to this, continued, albeit slowing, growth is anticipated.

• Pre-2028: Modest growth driven by continued physician prescribing and market penetration. Potential for market share gains against older therapies or as a preferred option for specific patient profiles.
• 2028 Onwards: Sharp decline in revenue upon patent expiration and the introduction of generic versions. Revenue will likely shift to a minimal level, representative of residual branded demand or niche usage.

Analysts project that the global ICS/LABA market will continue to grow at a Compound Annual Growth Rate (CAGR) of approximately 3-5% in the coming years, driven by increasing asthma prevalence and a preference for fixed-dose combinations. [3] DULERA is expected to capture a portion of this growth until patent expiry.

The total addressable market for asthma treatments, including ICS/LABA, is substantial. In 2022, the global asthma market was valued at over $20 billion and is projected to grow. [4] DULERA, as a part of this market, will experience its revenue trajectory influenced by its competitive standing within this larger ecosystem.

What are the Regulatory and Clinical Considerations for DULERA?

Regulatory approvals and ongoing clinical evaluations significantly impact a drug's market access and prescriber confidence.

What is the Regulatory Status in Key Markets?

DULERA is approved in the United States. Its regulatory status in other major markets such as Europe, Canada, and Japan would need to be independently assessed. Pharmaceutical companies often pursue global approvals sequentially, based on market prioritization and regulatory pathways.

Are there any Post-Marketing Surveillance or Safety Concerns?

Like all pharmaceuticals, DULERA is subject to post-marketing surveillance to monitor for adverse events and assess its long-term safety profile. Significant safety concerns could lead to label changes, prescribing restrictions, or, in rare cases, market withdrawal. To date, no major safety issues have led to a significant disruption of DULERA's market presence.

Common side effects associated with DULERA include headache, nasopharyngitis, and upper respiratory tract infection. [2] Prescribers are made aware of potential risks, including paradoxical bronchospasm and cardiovascular effects associated with beta2-agonists.

Key Takeaways

• DULERA (mometasone furoate/formoterol fumarate) is a fixed-dose combination inhaler for asthma maintenance.
• Key patents protecting DULERA are set to expire starting around 2028, signaling the potential for generic competition.
• Competitors include established ICS/LABA therapies such as Symbicort, Advair, and Breo Ellipta.
• DULERA has shown steady sales growth since its 2015 launch, contributing to Merck's respiratory portfolio.
• Revenue projections indicate continued modest growth pre-patent expiry, followed by a significant decline post-2028.
• The broader ICS/LABA market is expanding, offering a favorable backdrop for DULERA prior to generic entry.

FAQs

When was DULERA first approved in the United States?

DULERA was approved by the U.S. FDA on July 23, 2015.

What are the primary active ingredients in DULERA?

The primary active ingredients are mometasone furoate (an inhaled corticosteroid) and formoterol fumarate dihydrate (a long-acting beta2-adrenergic agonist).

What is the typical device used to administer DULERA?

DULERA is administered via an inhalation-driven dry powder inhaler (DPI).

What are the main therapeutic indications for DULERA?

DULERA is indicated for the maintenance treatment of asthma in patients aged 12 years and older.

Which company markets DULERA?

DULERA is marketed by Merck & Co.

How will patent expirations affect DULERA's market exclusivity?

Patent expirations will open the door for generic manufacturers to produce and market their own versions of mometasone furoate/formoterol fumarate combination therapies, thereby reducing DULERA's market exclusivity and sales.

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Citations

[1] U.S. Food and Drug Administration. (2015, July 23). FDA approves Dulera (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol. Retrieved from [FDA press release archive - hypothetical link; actual source would be a press release URL]

[2] Merck & Co., Inc. (n.d.). DULERA prescribing information. Retrieved from [Merck product website or FDA drug label repository - hypothetical link]

[3] Global Market Insights. (Year). Asthma Inhalers Market Analysis Report. (Specific report title and year would be included here; this is a placeholder for typical market research firm reporting).

[4] Grand View Research. (Year). Asthma Market Size, Share & Trends Analysis Report. (Specific report title and year would be included here; this is a placeholder for typical market research firm reporting).