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	022518-001	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 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
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	022518-001	Jun 22, 2010
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010

Market Dynamics and Financial Trajectory for Mometasone Furoate and Formoterol Fumarate

Introduction

Mometasone furoate and formoterol fumarate are two pharmaceutical compounds that have garnered significant attention in the healthcare industry, particularly in the treatment of respiratory and skin conditions. This article delves into the market dynamics and financial trajectory of these drugs, highlighting their growth drivers, challenges, and future projections.

Mometasone Furoate Market Overview

Market Size and Growth

The mometasone furoate market is expected to reach USD 3 billion by 2036, growing at a Compound Annual Growth Rate (CAGR) of 7% during the forecast period of 2024-2036. In 2023, the market size was valued at USD 1 billion[1].

Growth Drivers

• Rising Prevalence of Uncontrolled Asthma: The increasing incidence of uncontrolled asthma among children and adults is a significant driver. According to the CDC, about 44% of children and 60% of adults have uncontrolled asthma[1].
• Growing Awareness of Skincare: There is a rising awareness and focus on skincare and overall well-being, leading to increased demand for dermatological treatments like mometasone furoate[1].
• Aging Population: The expansion of the aging population worldwide is also contributing to the growth of the sector[1].

Route of Administration

The topical segment of the mometasone furoate market is expected to account for around 42% of the market share by 2036. This is driven by the surge in skin conditions like eczema, psoriasis, and dermatitis, affecting approximately 223 million people worldwide, including 43 million children and young adults[1].

Geographical Performance

• North America: Expected to capture over 47% of the mometasone furoate market share by 2036, driven by awareness campaigns and the high prevalence of skin conditions like psoriasis and eczema[1].
• Europe: Will account for the second largest share, influenced by the aging population, increasing need for dermatological products, and the presence of e-commerce and online pharmacies[1].

Formoterol Fumarate Market Overview

Market Size and Growth

The formoterol fumarate market is anticipated to grow at a CAGR of 3 to 5% from its estimated valuation by 2031. The market is segmented based on application (asthma, allergic rhinitis, others) and product (powder, capsule)[3].

Growth Drivers

• Increasing Prevalence of Respiratory Conditions: The rising incidence of asthma and COPD is driving the demand for formoterol fumarate.
• Advancements in Formulation Technology: Improvements in inhalation devices and formulations have enhanced the efficacy and patient compliance of formoterol fumarate[2][4].

Combination Therapy: Mometasone Furoate and Formoterol Fumarate

Clinical Efficacy

The combination of mometasone furoate and formoterol fumarate, known as DULERA, has shown significant clinical efficacy in treating asthma and COPD. Studies have demonstrated improvements in lung function, respiratory health status, and reduction in exacerbations. This combination is well-tolerated and has been approved by the FDA for the treatment of asthma in patients 12 years and older[4][5].

Market Impact

The approval and efficacy of DULERA have positively impacted the market for both mometasone furoate and formoterol fumarate. The combination therapy addresses multiple aspects of respiratory health, making it a preferred option for healthcare professionals and patients[4][5].

Challenges and Opportunities

Regulatory Environment

Changes in regulatory policies and approval processes can significantly impact the market trajectory of these drugs. Strict regulations and the need for extensive clinical trials can pose challenges but also ensure the safety and efficacy of the treatments[4][5].

Competitive Landscape

The pharmaceutical market is highly competitive, with numerous players offering similar treatments. Differentiation through innovative formulations, delivery systems, and marketing strategies is crucial for maintaining market share[1][3].

Patient Compliance and Education

Patient education and compliance are key factors in the success of these treatments. Awareness campaigns and healthcare provider education can enhance patient adherence and overall market growth[1].

Financial Projections

Mometasone Furoate

• The market is projected to reach USD 3 billion by 2036, with a CAGR of 7% during the forecast period[1].

Formoterol Fumarate

• The market is expected to grow at a CAGR of 3 to 5% by 2031, although the exact valuation is not specified[3].

Regional Market Performance

North America

• For mometasone furoate, North America is expected to capture over 47% of the market share by 2036, driven by high awareness and prevalence of skin conditions[1].

Europe

• The European region will also see significant growth, driven by the aging population and increasing investments in healthcare[1].

Key Takeaways

• The mometasone furoate market is driven by the rising prevalence of uncontrolled asthma and growing awareness of skincare.
• Formoterol fumarate's market growth is influenced by the increasing prevalence of respiratory conditions and advancements in formulation technology.
• The combination therapy of mometasone furoate and formoterol fumarate (DULERA) has shown significant clinical efficacy and is a key driver in the market.
• Regulatory environment, competitive landscape, and patient compliance are critical factors in the market dynamics of these drugs.

FAQs

Q: What is the projected market size of mometasone furoate by 2036? A: The mometasone furoate market is expected to reach USD 3 billion by 2036[1].

Q: What are the primary growth drivers for the mometasone furoate market? A: The primary growth drivers include the rising prevalence of uncontrolled asthma, growing awareness of skincare, and the expansion of the aging population[1].

Q: How does the combination therapy of mometasone furoate and formoterol fumarate impact the market? A: The combination therapy, known as DULERA, has shown significant clinical efficacy in treating asthma and COPD, positively impacting the market for both drugs[4][5].

Q: What is the expected CAGR for the formoterol fumarate market by 2031? A: The formoterol fumarate market is expected to grow at a CAGR of 3 to 5% by 2031[3].

Q: Which region is expected to capture the largest share of the mometasone furoate market by 2036? A: North America is expected to capture over 47% of the mometasone furoate market share by 2036[1].

Cited Sources

1. Research Nester, "Mometasone Furoate Market Size & Share, Growth Trends 2036," May 7, 2024.
2. PubMed, "Effects of mometasone furoate/formoterol fumarate fixed-dose combination on lung function and respiratory health status in subjects with moderate-to-very severe chronic obstructive pulmonary disease," 2012.
3. Market Research Intellect, "Formoterol Fumarate Market Size And Forecast," December 2024.
4. Managed Healthcare Executive, "Mometasone furoate and formoterol fumarate dihydrate (Dulera)," August 1, 2010.
5. Merck, "Merck Announces Presentation of Phase III Investigational Studies Evaluating DULERA® (mometasone furoate and formoterol fumarate dihydrate) in Adults with COPD," October 24, 2011.