Mometasone furoate - Generic Drug Details

What are the generic sources for mometasone furoate and what is the scope of patent protection?

Mometasone furoate is the generic ingredient in eight branded drugs marketed by Organon Llc, Organon, Anda Repository, Cosette, Fougera Pharms, Glenmark Pharms Inc, Taro, Intersect Ent Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Aurobindo Pharma, Perrigo Pharma Intl, and Glenmark Speclt, and is included in thirty-two NDAs. There are twenty-eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mometasone furoate has forty-seven patent family members in twelve countries.

There are twenty-seven drug master file entries for mometasone furoate. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mometasone furoate

International Patents:	47
US Patents:	28
Tradenames:	8
Applicants:	19
NDAs:	32
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	143
Patent Applications:	6,223
Drug Prices:	Drug price trends for mometasone furoate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mometasone furoate
What excipients (inactive ingredients) are in mometasone furoate?	mometasone furoate excipients list
DailyMed Link:	mometasone furoate at DailyMed

See drug prices for mometasone furoate

See drug sales revenues for mometasone furoate

Recent Clinical Trials for mometasone furoate

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

Sponsor	Phase
Zheng Liu	N/A
MEDA Pharma GmbH & Co. KG	Phase 2
Morten Hostrup, PhD	N/A

See all mometasone furoate clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE

Applicant	Application No.	Strength	Dosage Form
		0.05MG/SPRAY	SPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for mometasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for mometasone furoate

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

Anatomical Therapeutic Chemical (ATC) Classes for 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

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for MOMETASONE FUROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07
ELOCON	Topical Solution (Lotion)	mometasone furoate	0.1%	019796	1	2004-06-10

US Patents and Regulatory Information for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987		DISCN	No	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Amneal Pharms	MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	207989-001	Apr 3, 2017	AB	RX	No	No

Expired US Patents for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	6,503,537*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	5,687,710*PED
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987	4,808,610*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	5,829,434*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	5,394,868*PED
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	6,677,322*PED

International Patents for mometasone furoate

Country	Patent Number	Title	Estimated Expiration
Japan	2016512129	副鼻腔状態を処置するためのシステム、デバイスおよび方法
European Patent Office	2298319	Dispositifs et procédés de traitement des affections sinus paranasaux (Device and methods for treating paranasal sinus conditions)
World Intellectual Property Organization (WIPO)	2004082525
Mexico	2007012324	DISPOSITIVO Y METODO PARA TRATAR CONDICIONES DEL SENO PARANASAL. (DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS.)
European Patent Office	3103422	DISTRIBUTION PAR SINUS D'AGENTS THÉRAPEUTIQUES À LIBÉRATION PROLONGÉE (SINUS DELIVERY OF SUSTAINED RELEASE THERAPEUTICS)
Canada	2732355	PROCEDES ET DISPOSITIFS POUR SERTIR DES DISPOSITIFS AUTO-DILATABLES (METHODS AND DEVICES FOR CRIMPING SELF-EXPANDING DEVICES)

Supplementary Protection Certificates for mometasone furoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426

Mometasone furoate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mometasone Furoate

Market Overview

Mometasone furoate, a potent corticosteroid, is widely used to treat various conditions including asthma, allergic rhinitis, and inflammatory skin disorders. The market for mometasone furoate is experiencing significant growth driven by several key factors.

Growth Drivers

Increasing Prevalence of Chronic Conditions

The rising incidence of uncontrolled asthma, allergic rhinitis, and inflammatory skin conditions such as eczema, psoriasis, and dermatitis is a major driver of the mometasone furoate market. According to the CDC, about 44% of children and 60% of adults suffer from uncontrolled asthma, which significantly contributes to the demand for mometasone furoate[1].

Advancements in Formulation Technology

Improvements in formulation technology have enhanced the delivery and absorption of mometasone furoate through the skin, making it more effective in treating skin conditions. For instance, the development of aspasomal mometasone furoate gel has shown promising results in delivering the drug over a longer period and requiring lower doses, thus expanding the scope of psoriasis treatment[4].

Aging Population and Skincare Awareness

The expanding aging population worldwide and the increasing awareness and focus on skincare and overall well-being are also driving the market. People are becoming more conscious of their skin health, leading to a higher demand for dermatological treatments like mometasone furoate[1].

Market Segments

Route of Administration

The topical segment of the mometasone furoate market is expected to account for around 42% of the market share by 2036, driven by the surge in skin conditions like eczema, psoriasis, and dermatitis. Mometasone furoate in the form of creams, ointments, and lotions has shown great efficacy in managing these conditions[1].

Indications

The allergic rhinitis segment is set to garner a notable share, driven by the growth in diagnostic techniques and the financial burden associated with the condition. Mometasone nasal spray is frequently recommended to reduce allergic rhinitis symptoms, contributing to the market expansion[1].

Geographical Analysis

North American Market

North America is expected to capture over 47% of the mometasone furoate market share by 2036. The region's growth is attributed to the high prevalence of skin conditions like psoriasis and eczema, as well as increasing awareness campaigns and demand for advanced skincare products[1].

European Market

The European region will also significantly influence the market growth, driven by approvals for mometasone spray, an aging population, and the increasing need for such products. The presence of e-commerce and online pharmacies has made it easier for people to access mometasone furoate products[1].

Asia Pacific Market

Asia Pacific is anticipated to be the fastest-growing region, fueled by the growing population of patients with inflammatory skin diseases and the increasing number of domestic manufacturers[4].

Financial Trajectory

Market Size and Growth

The global mometasone furoate market is projected to reach USD 3 billion by 2036, growing at a CAGR of 7% during the forecast period from 2024 to 2036. In 2023, the market size was valued at USD 1 billion[1].

Revenue Projections

Another forecast indicates that the market will grow from $1.18 billion to $2.21 billion at a CAGR of 7.2% during the period from 2021 to 2030[4].

Clinical Trials and Innovations

Lyra Therapeutics

Lyra Therapeutics is conducting pivotal Phase 3 clinical trials (ENLIGHTEN I and ENLIGHTEN II) to evaluate the efficacy and safety of LYR-210, which contains 7500µg of mometasone furoate, for the treatment of chronic rhinosinusitis (CRS). These trials aim to support a New Drug Application to the FDA[2].

Challenges and Restraints

Research and Development Costs

The increase in research and development expenses, as seen in companies like Lyra Therapeutics, can be a challenge. Higher clinical development costs and employee-related expenses are driving up R&D spending[2].

Impairment Charges

Impairment charges related to long-lived assets can also impact the financial health of companies involved in the mometasone furoate market. These charges reflect potential overestimation of asset values or changes in the expected utility of these assets[2].

Key Takeaways

• The mometasone furoate market is driven by the increasing prevalence of chronic conditions, advancements in formulation technology, and growing awareness of skincare.
• The topical segment is expected to dominate the market due to its efficacy in treating skin conditions.
• North America and Europe are key regions driving market growth, with Asia Pacific emerging as a fast-growing market.
• Clinical trials and innovations, such as those by Lyra Therapeutics, are crucial for market expansion.
• Despite growth, the market faces challenges related to R&D costs and asset impairment charges.

FAQs

1. What is the projected market size of mometasone furoate by 2036?

The global mometasone furoate market is projected to reach USD 3 billion by 2036, growing at a CAGR of 7% during the forecast period from 2024 to 2036[1].

2. Which segment is expected to dominate the mometasone furoate market?

The topical segment is expected to account for around 42% of the market share by 2036, driven by the surge in skin conditions like eczema, psoriasis, and dermatitis[1].

3. What are the key drivers of the mometasone furoate market?

The key drivers include the increasing prevalence of chronic conditions, advancements in formulation technology, and growing awareness of skincare and overall well-being[1][4].

4. Which region is expected to capture the largest market share of mometasone furoate?

North America is expected to capture over 47% of the mometasone furoate market share by 2036[1].

5. What are the challenges faced by companies in the mometasone furoate market?

Challenges include increasing research and development expenses and impairment charges related to long-lived assets[2].

Cited Sources:

1. Research Nester: Mometasone Furoate Market Size & Share, Growth Trends 2036[1]
2. Stock Titan: Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update[2]
3. GlobeNewswire: Nasal Corticosteroids Market to Reach Over $11.4 Billion by 2034 Amid Rising Chronic Respiratory Disorders[3]
4. Factual Market Research: Mometasone Furoate Market Size, Share, Growth Analysis, Trends[4]