Mometasone furoate; olopatadine hydrochloride - Generic Drug Details

What are the generic sources for mometasone furoate; olopatadine hydrochloride and what is the scope of freedom to operate?

Mometasone furoate; olopatadine hydrochloride is the generic ingredient in one branded drug marketed by Glenmark Speclt and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mometasone furoate; olopatadine hydrochloride has ninety patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for mometasone furoate; olopatadine hydrochloride

International Patents:	90
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	mometasone furoate; olopatadine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for mometasone furoate; olopatadine hydrochloride

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for mometasone furoate; olopatadine hydrochloride

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

Sponsor	Phase
MEDA Pharma GmbH & Co. KG	Phase 2
Glenmark Specialty S.A.	Phase 3
Glenmark Pharmaceuticals Ltd. India	Phase 2

See all mometasone furoate; olopatadine hydrochloride clinical trials

Pharmacology for mometasone furoate; olopatadine hydrochloride

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Anatomical Therapeutic Chemical (ATC) Classes for mometasone furoate; olopatadine hydrochloride

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

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

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

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for mometasone furoate; olopatadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	9,078,923		Y
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,548,907
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,517,880		Y
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	11,679,210		Y
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,376,526		Y

International Patents for mometasone furoate; olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	111787954	使用莫美他松和奥洛他定的组合治疗儿科受试者的过敏性鼻炎 (TREATMENT OF ALLERGIC RHINITIS IN PEDIATRIC SUBJECTS USING A COMBINATION OF MOMETASONE AND OLOPATADINE)
Mexico	2018015739	DISPOSITIVO DISPENSADOR Y COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE LA RINITIS. (DISPENSING DEVICE AND PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF RHINITIS.)
World Intellectual Property Organization (WIPO)	2019006173
Russian Federation	2020126691	ЛЕЧЕНИЕ АЛЛЕРГИЧЕСКОГО РИНИТА У СУБЪЕКТОВ ДЕТСКОЙ ВОЗРАСТНОЙ КАТЕГОРИИ С ПРИМЕНЕНИЕМ КОМБИНАЦИИ МОМЕТАЗОНА И ОЛОПАТАДИНА
Spain	2849026

Supplementary Protection Certificates for mometasone furoate; olopatadine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
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
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622

Mometasone furoate; olopatadine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mometasone Furoate and Olopatadine Hydrochloride

Introduction to Mometasone Furoate and Olopatadine Hydrochloride

Mometasone furoate and olopatadine hydrochloride are two pharmaceutical compounds that have been gaining significant traction in the global healthcare market. Mometasone furoate is a corticosteroid used to treat various conditions such as asthma, hay fever, and several skin problems, while olopatadine hydrochloride is an antihistamine primarily used to treat allergic rhinitis and conjunctivitis.

Market Size and Growth Projections for Mometasone Furoate

Current Market Size

The global mometasone furoate market was valued at approximately $1.18 billion in 2022 and is projected to grow to $2.21 billion by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period[3][5].

Regional Dominance

North America is expected to continue dominating the mometasone furoate market due to high approval rates and the commercialization of biopharmaceuticals. The Asia Pacific region, however, is anticipated to be the fastest-growing market, driven by the increasing population of patients with inflammatory skin diseases and the rise of domestic manufacturers[3].

Market Size and Growth Projections for Olopatadine Hydrochloride

Current Market Size

The olopatadine hydrochloride market is anticipated to witness significant growth, with a projected CAGR of 15.46% from 2024 to 2031. The market is expected to transition from a valuation of USD 2.85 billion in 2024 to USD 7.8 billion by 2031[4].

Regional Growth

The Asia-Pacific region is a key driver for the olopatadine hydrochloride market, fueled by countries such as China, Japan, India, and South Korea. This region benefits from a large population, rising disposable income, and increasing urbanization. Europe and Latin America also represent significant markets, with Europe characterized by a mature market and Latin America offering opportunities despite economic fluctuations[4].

Drivers of Market Growth

Increasing Prevalence of Allergies and Skin Conditions

Both markets are driven by the increasing prevalence of allergies and skin conditions. For olopatadine hydrochloride, the rise in allergy-related illnesses such as allergic rhinitis and conjunctivitis, exacerbated by pollution and environmental changes, is a significant driver[4].

Advanced Technologies and Formulations

The development of innovative formulations, such as nasal sprays and eye drops, has enhanced patient convenience and driven demand for both mometasone furoate and olopatadine hydrochloride. For instance, research on aspasomal mometasone furoate gel has shown promising results in treating psoriasis with fewer doses and longer delivery times[5].

Healthcare Infrastructure and Awareness

The expansion of healthcare infrastructure in developing nations and increased awareness of allergy treatments have significantly boosted the demand for these medications. This is particularly evident in the Asia Pacific region, where growing healthcare access and awareness are key factors[3][4].

Restraints and Challenges

Regulatory Hurdles

Both markets face regulatory challenges, including stringent approval processes and varying regulatory environments across different regions. These hurdles can slow down the introduction of new products and formulations[2][4].

Economic Fluctuations

Economic instability in certain regions, such as Latin America, can impact market dynamics and consumer behavior, posing a challenge to the consistent growth of these markets[4].

Opportunities and Future Outlook

Research and Development

Increasing research and development activities are expected to drive the growth of both markets. For mometasone furoate, advancements in formulation and delivery systems, such as the aspasomal gel, are expanding treatment options and improving patient outcomes[5].

Mergers and Acquisitions

The olopatadine hydrochloride market is witnessing a wave of mergers and acquisitions, which are helping companies consolidate their market positions, expand product portfolios, and leverage synergies to drive growth and competitiveness[4].

Sustainable Solutions

Growing environmental concerns and the shift towards sustainable alternatives are also expected to boost the demand for eco-friendly versions of these medications, offering new opportunities for market growth[4].

Key Players and Market Competition

Mometasone Furoate Market

The mometasone furoate market is characterized by a competitive landscape with several key players involved in research, development, and commercialization. The focus on innovative formulations and delivery systems is a key differentiator among these players[3][5].

Olopatadine Hydrochloride Market

The olopatadine hydrochloride market includes major players such as Sumitomo Chemical, Enaltec, Shiono Chemical, FDC, and Fabbrica Italiana Sintetici. These companies are driving growth through technological innovations, strategic acquisitions, and expansion into emerging markets[4].

Regional Analysis

North America

North America remains a dominant region for both markets, driven by high approval rates and the commercialization of advanced biopharmaceuticals. The region's mature healthcare infrastructure and high consumer awareness also contribute to its leading position[3][4].

Asia Pacific

The Asia Pacific region is emerging as a significant growth hub for both mometasone furoate and olopatadine hydrochloride. The large population, rising disposable income, and increasing urbanization in countries like China, Japan, India, and South Korea are driving this growth[3][4].

Europe and Latin America

Europe is characterized by a mature market with well-established infrastructure and consumer preferences. Latin America, while presenting opportunities, also faces challenges due to economic fluctuations and political instability[4].

Financial Trajectory

Revenue Projections

The mometasone furoate market is projected to grow from $1.18 billion to $2.21 billion by 2030, while the olopatadine hydrochloride market is expected to grow from $2.85 billion in 2024 to $7.8 billion by 2031[3][4].

CAGR

The CAGR for the mometasone furoate market is estimated at 7.2% from 2021 to 2030, while the olopatadine hydrochloride market is expected to exhibit a CAGR of 15.46% from 2024 to 2031[3][4].

Key Takeaways

• Market Growth: Both mometasone furoate and olopatadine hydrochloride markets are expected to experience significant growth driven by increasing prevalence of allergies and skin conditions, advanced technologies, and expanding healthcare infrastructure.
• Regional Dominance: North America and the Asia Pacific region are key drivers for these markets, with North America leading due to its mature healthcare infrastructure and the Asia Pacific region growing rapidly due to its large population and increasing urbanization.
• Drivers and Restraints: The markets are driven by technological innovations, increasing awareness, and expanding healthcare access, but face challenges such as regulatory hurdles and economic fluctuations.
• Future Outlook: The focus on research and development, mergers and acquisitions, and sustainable solutions is expected to continue driving growth in these markets.

FAQs

What is the current market size of the mometasone furoate market?

The global mometasone furoate market was valued at approximately $1.18 billion in 2022[5].

What is the projected growth rate for the olopatadine hydrochloride market?

The olopatadine hydrochloride market is expected to exhibit a CAGR of 15.46% from 2024 to 2031[4].

Which regions are driving the growth of the mometasone furoate market?

North America and the Asia Pacific region are the key drivers for the mometasone furoate market[3].

What are the main drivers of the olopatadine hydrochloride market?

The main drivers include the increasing prevalence of allergies, technological innovations in drug administration, and the aging population[4].

Who are the key players in the olopatadine hydrochloride market?

Key players include Sumitomo Chemical, Enaltec, Shiono Chemical, FDC, and Fabbrica Italiana Sintetici[4].

Sources

1. Market Research Intellect: Global Mometasone Furoate Market Size, Trends and Projections.
2. Market Research Intellect: Olopatadine Hydrochloride Market Size, Scope And Forecast Report.
3. Factual Market Research: Mometasone Furoate Market Size, Share, Growth Analysis, Trends.
4. OpenPR: Olopatadine Hydrochloride Market Size, Share and Forecast.
5. Coherent Market Insights: Mometasone Furoate Market Size and Trends.