Mometasone furoate; olopatadine hydrochloride - Generic Drug Details

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

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

Mometasone furoate; olopatadine hydrochloride has one hundred patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for mometasone furoate; olopatadine hydrochloride

International Patents:	100
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	mometasone furoate; olopatadine hydrochloride at DailyMed

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
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y	Y

International Patents for mometasone furoate; olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2020126691	ЛЕЧЕНИЕ АЛЛЕРГИЧЕСКОГО РИНИТА У СУБЪЕКТОВ ДЕТСКОЙ ВОЗРАСТНОЙ КАТЕГОРИИ С ПРИМЕНЕНИЕМ КОМБИНАЦИИ МОМЕТАЗОНА И ОЛОПАТАДИНА
San Marino	T202100563
Russian Federation	2687551
Hungary	E056448
European Patent Office	4272839	TRAITEMENT DE LA RHINITE ALLERGIQUE À L'AIDE D'UNE ASSOCIATION DE MOMÉTASONE ET D'OLOPATADINE (TREATMENT OF ALLERGIC RHINITIS USING A COMBINATION OF MOMETASONE AND OLOPATADINE)

Supplementary Protection Certificates for mometasone furoate; olopatadine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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	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	57/2021	Austria		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: 140638 20210426
3043773	2021045	Norway		PRODUCT NAME: MOMETASON ELLER ET SALT DERAV OG OLOPATADIN ELLER ET SALT DERAV; NAT. REG. NO/DATE: 20-13278 20210709; FIRST REG. NO/DATE: 140638 20210426

Market Dynamics and Financial Trajectory for Mometasone Furoate and Olopatadine Hydrochloride

Last updated: July 30, 2025

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Introduction

The pharmaceutical landscape for respiratory and allergic conditions has experienced significant evolution, particularly in the segment of corticosteroid and antihistamine therapies. Mometasone furoate and olopatadine hydrochloride have positioned themselves as prominent agents within this domain, offering therapeutic benefits for asthma, allergic rhinitis, and related conditions. Understanding their market dynamics and financial trajectory is essential for stakeholders aiming to capitalize on growth opportunities and navigate competitive challenges.

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Market Overview

Mometasone Furoate

Mometasone furoate is a potent corticosteroid nasal spray primarily used for managing allergic rhinitis and nasal congestion. Its anti-inflammatory properties provide targeted symptom relief, making it a cornerstone in both prescription and OTC formulations.

Olopatadine Hydrochloride

Olopatadine is an antihistamine used to treat allergic conjunctivitis, allergic rhinitis, and other hypersensitivity conditions. Available as nasal sprays, ophthalmic solutions, and oral tablets, olopatadine's versatile formulations cater to a broad patient demographic.

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Market Dynamics

Drivers

1. Rising Prevalence of Allergic and Respiratory Disorders
   The global increase in allergic rhinitis, asthma, and nasal congestion—driven by urbanization, pollution, and climate change—fosters sustained demand for efficacious therapies such as mometasone furoate and olopatadine hydrochloride. According to the World Allergy Organization, allergic rhinitis affects approximately 10-30% of the global population, underpinning market expansion.

2. Expanding Over-the-Counter (OTC) Availability
   Regulatory shifts enabling OTC sales have broadened consumer access, elevating market volume and frequency of use, especially for mometasone nasal sprays and olopatadine formulations.

3. Enhanced Formulation Technologies
   Innovations in drug delivery, including metered-dose sprays and preservative-free formulations, have improved patient compliance and safety profiles, encouraging broader adoption.

4. Growing Aging Population and Urbanization
   Elder populations and urban communities experience higher susceptibility to allergic diseases, fueling demand. The WHO estimates the population aged 60 and above will constitute nearly 22% of the global population by 2050, a demographic prone to respiratory conditions.

Challenges

1. Market Saturation and Competitive Intensity
   The corticosteroid and antihistamine segments are densely populated with established brands like Flonase (fluticasone), Nasacort (triamcinolone), and azelastine, creating high entry barriers for new entrants and fostering price competition.

2. Stringent Regulatory Frameworks
   Patent expirations, such as the loss of exclusivity for certain mometasone and olopatadine products, lead to generic proliferation, impacting pricing and profit margins.

3. Safety & Side-effect Concerns
   Reports of corticosteroid-related side effects, including nasal irritation or systemic absorption risks, may influence prescribing practices and market perceptions. Similarly, concerns over antihistamine sedation influence formulation development.

4. Impact of COVID-19
   The pandemic disrupted supply chains and delayed clinical trials but also increased demand for respiratory therapies, though the post-pandemic phase anticipates normalization.

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Financial Trajectory & Market Forecasts

Market Size and Growth Projections

• The global nasal corticosteroid market, including mometasone furoate, was valued at approximately $2.1 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% through 2030 (Grand View Research). Factors propelling growth include increased allergic rhinitis prevalence and product innovations.

• The antihistamine market, with olopatadine at its forefront, was estimated at $1.8 billion in 2022, expanding at a CAGR of 6.0% into 2030. The expansion is driven by allergy awareness campaigns, OTC accessibility, and new formulations.

Revenue Streams

• Prescription vs. OTC: OTC sales constitute a substantial component, especially in developed markets, due to regulatory relaxations and consumer preferences for self-medication.

• Geographic Variability: North America leads in both markets owing to high allergy prevalence and mature healthcare systems, followed by Europe and Asia-Pacific, where rising urbanization and healthcare investments stimulate growth.

Competitive Dynamics Impacting Financials

• Patent expirations have historically pressured pricing and margins. For instance, the lapsing of patent exclusivity for mometasone furoate nasal sprays in certain regions has led to a surge in generics, reducing revenue margins for innovator companies but expanding market volume overall.

• Strategic partnerships and licensing deals are increasingly used by pharmaceutical companies to extend product life cycles and gain market access mutually.

• Revenue diversification into combination therapies (e.g., mometasone with azelastine) has opened new revenue avenues, enhancing market share.

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Strategic Outlook

Innovation & Biologic Integration

While mometasone furoate and olopatadine remain primarily small-molecule agents, emerging biologics targeting allergic pathways could alter the competitive landscape. However, their higher costs and targeted applications limit immediate market impact, maintaining the relevance of established therapies.

Regulatory & Policy Trends

• Increased regulatory scrutiny emphasizes safety, with agencies advocating for post-market surveillance and phase IV studies, potentially influencing market stability.

• Policies promoting OTC availability are expected to continue in developed nations, accelerating consumer access and sales.

Market Entry & Expansion Strategies

• Launching combination products and novel delivery systems can capture unmet needs and extend patent life.

• Expanding into emerging markets with strategic pricing and localized formulations leveraging regulatory incentives offers high-growth prospects.

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Key Takeaways

• The global market for mometasone furoate and olopatadine hydrochloride is projected to grow steadily, driven by rising allergy prevalence and OTC accessibility.

• Patent expirations and increasing generic competition compress profit margins but expand overall market volume, emphasizing the importance of innovation and strategic partnerships.

• Geographic and demographic trends favor North America and Asia-Pacific for continued expansion. Developing markets present substantial growth opportunities given increasing urbanization and rising allergy awareness.

• Formulation advancements and combination therapies serve as critical tactics for differentiating products and maintaining market share amid competitive pressures.

• Regulatory landscapes will continue to shape product development, marketing strategies, and pricing models, necessitating proactive compliance and epidemiological insights.

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FAQs

Q1: How will patent expirations impact the profitability of mometasone furoate and olopatadine hydrochloride?
Patent expirations typically lead to increased generic competition, lowering prices and profit margins for original innovators. To mitigate this, companies are investing in formulation innovations, combination products, and expanding into emerging markets.

Q2: What are the main growth opportunities in the olopatadine market?
The primary opportunities lie in developing new formulations (e.g., prolonged-release tablets), expanding OTC availability, and targeting under-served regions such as Asia-Pacific with tailored marketing strategies.

Q3: How has COVID-19 affected the market trajectory for these drugs?
COVID-19 initially disrupted supply chains but increased awareness of respiratory and allergic conditions, catalyzing sales of nasal corticosteroids and antihistamines. Post-pandemic, a normalization in supply and continued demand sustain positive growth prospects.

Q4: What role do regulatory agencies play in shaping market dynamics?
Regulatory agencies influence the market through approvals, safety standards, and policies on OTC sales. They can facilitate market entry via streamlined approval processes (e.g., in certain countries), but also impose safety mandates that increase development costs.

Q5: Are biologics a threat to mometasone and olopatadine therapies?
Currently, biologics target more severe or specific allergic conditions and are costly, limiting their impact on established corticosteroids and antihistamines. Nonetheless, their evolution may influence future market dynamics, especially for complex or refractory cases.

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References

[1] Grand View Research. Nasal Corticosteroids Market Size & Trends. 2022.
[2] World Allergy Organization. Global Prevalence of Allergic Rhinitis. 2021.
[3] MarketWatch. Olopatadine Hydrochloride Market Forecast. 2023.