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	022518-001	Jun 22, 2010		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-003	Aug 12, 2019		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	6,068,832
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	6,068,832
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	5,889,015*PED
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	6,677,323

International Patents for DULERA

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

Country	Patent Number	Title	Estimated Expiration
Australia	691880
China	101164542
Hungary	T74884
Spain	2369516
United Kingdom	9904919

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
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
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210

Market Dynamics and Financial Trajectory for DULERA

Introduction to DULERA

DULERA, a prescription medication, is a combination of mometasone furoate and formoterol fumarate, used for the long-term control and prevention of symptoms of asthma in patients 12 years of age and older. It is one of the key products in the respiratory drug market, particularly within the asthma medication segment.

Market Overview of Asthma Medications

The global asthma medication market is highly competitive and moderately consolidated, with a few major players dominating the market. Companies like GlaxoSmithKline (GSK), AstraZeneca, and Merck & Co. Inc. are among the prominent players in this sector[1][3][4].

Market Growth Drivers

Several factors are driving the growth of the asthma medication market, including:

Rising Prevalence of Respiratory Diseases

The increasing incidence of respiratory diseases such as asthma and COPD is a significant driver. According to the World Health Organization (WHO), respiratory diseases are among the leading causes of death globally, with COPD being the third leading cause[3].

Aging Population

The rising percentage of geriatrics in the world population also contributes to the demand for asthma medications. Older adults are more prone to respiratory issues, which increases the need for effective treatments[1].

Advancements in Drug Therapies

The development of innovative applications, biologics, and targeted therapies for respiratory diseases is another key driver. These advanced treatments offer improved efficacy and safety profiles compared to traditional therapies[3].

Competitive Landscape

The competitive landscape of the asthma medication market is intense. Major players are engaging in strategic partnerships, mergers and acquisitions, and new product launches to strengthen their market position. For instance, companies like GSK and AstraZeneca are focusing on developing combination therapies and biologics to enhance their market share[1][3][4].

Financial Performance of Key Players

GlaxoSmithKline (GSK)

GSK, the manufacturer of DULERA, operates in a highly competitive market. While specific financial data for DULERA is not publicly disclosed, GSK's overall respiratory drug portfolio contributes significantly to its revenue. The company's focus on innovative therapies and strategic partnerships is crucial for maintaining its market position[1][3].

Revenue and Market Share

The global respiratory drug market, which includes asthma medications like DULERA, is projected to grow substantially. The market size was valued at USD 43,040 million in 2023 and is expected to reach USD 71,489.66 million by 2032, exhibiting a CAGR of 5.8% during the forecast period[3].

Regional Dynamics

North America and Europe

These regions hold prominent market shares due to advanced healthcare systems, high patient awareness, and substantial research and development activities. The Americas are expected to dominate the asthma and COPD drug market, driven by the high prevalence of these conditions and increased healthcare expenditures[3][4].

Asia-Pacific and Emerging Markets

The Asia-Pacific region is expected to register the highest CAGR during the forecast period, driven by increasing healthcare expenditure, rising awareness about respiratory diseases, and a growing patient population. This presents a significant opportunity for companies like GSK to expand their presence in these emerging markets[3].

Innovative Trends and Technologies

Biologics and Targeted Therapies

The increasing adoption of biologics and targeted therapies for respiratory diseases is a notable trend. These advanced treatments offer improved efficacy and safety profiles, driving market growth and better patient outcomes[3].

Digital Health Technologies

The integration of digital health technologies, such as mobile health apps and smart inhalers, is also a trend. These technologies enable patients to monitor their symptoms, track medication usage, and receive reminders for treatment, leading to improved adherence and better disease management[3].

Challenges and Opportunities

Regulatory Environment

The regulatory environment varies significantly by region, influencing the market dynamics. Understanding these regional dynamics is essential for companies to maximize their reach and impact[3].

Emerging Markets

Countries in Asia-Pacific, Latin America, and Africa are witnessing a rising incidence of respiratory diseases due to urbanization, pollution, and lifestyle changes. As healthcare infrastructure in these regions improves, the demand for respiratory drugs like DULERA is expected to grow[3].

Key Takeaways

• The global asthma medication market, including DULERA, is expected to grow steadily driven by the rising prevalence of respiratory diseases and advancements in drug therapies.
• Major players like GSK are focusing on strategic partnerships and innovative therapies to maintain their market position.
• The Asia-Pacific region presents significant growth opportunities due to increasing healthcare expenditure and a growing patient population.
• Digital health technologies and biologics are key trends shaping the market.

FAQs

1. What is DULERA used for? DULERA is a prescription medication used for the long-term control and prevention of symptoms of asthma in patients 12 years of age and older.

2. Who are the major players in the asthma medication market? Major players include GlaxoSmithKline (GSK), AstraZeneca, Merck & Co. Inc., and others.

3. What are the key drivers of the asthma medication market? Key drivers include the rising prevalence of respiratory diseases, advancements in drug therapies, and the growing demand for early detection and treatment of these diseases.

4. How is the competitive landscape of the asthma medication market? The market is highly competitive and moderately consolidated, with major players engaging in strategic partnerships, mergers and acquisitions, and new product launches.

5. What are the emerging trends in the respiratory drug market? Emerging trends include the increasing adoption of biologics and targeted therapies, the development of combination therapies, and the integration of digital health technologies.

Cited Sources:

1. Biospace: "Asthma Medication Market to Witness Steady Expansion During 2020 to 2029"
2. Regeneron: "Regeneron Reports Fourth Quarter and Full Year 2023 Financial"
3. Global Growth Insights: "Respiratory Drug Market Size, Share & Growth Analysis | 2031"
4. GlobeNewswire: "Asthma and COPD Drugs Market Size to Hit USD 34,374.23 Million by 2030 at 4.20% CAGR – Report by Market Research Future (MRFR)"