mometasone furoate; olopatadine hydrochloride - Profile

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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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for mometasone furoate; olopatadine hydrochloride

International Patents:	108
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

12,303,635

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.

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	10,765,686
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,758,550
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,646,500
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	11,400,101
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	12,064,442
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,016,443

International Patents for mometasone furoate; olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2018260934	Dispensing device and pharmaceutical compositions for the treatment of rhinitis
Australia	2019224850	Treatment of allergic rhinitis in pediatric subjects using a combination of mometasone and olopatadine
Brazil	112015018252	composição farmacêutica aquosa de dose fixa estável para administração nasal para um ser humano, composição de suspensão aquosa farmacêutica de dose fixa estável para administração nasal para um ser humano, suspensão estável adequada para administração nasal a um ser humano, método para tratar rinite em um ser humano necessitando do mesmo, uso da composição farmacêutica para administração nasal, método para liberar uma composição farmacêutica e kit
Brazil	112018076537	dispositivo de distribuição e composição farmacêutica para administração nasal a um humano
Brazil	112020016817	método para tratar sintomas associados à rinite alérgica, método para fornecer um início de ação mais rápido para alívio da rinite alérgica e método para tratar um sujeito humano pediátrico que sofre de rinite alérgica
Canada	3023355	DISPOSITIF DISTRIBUTEUR ET COMPOSITION PHARMACEUTIQUE DESTINES AU TRAITEMENT DE LA RHINITE (DISPENSING DEVICE AND PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF RHINITIS)
Canada	3088490	TRAITEMENT DE LA RHINITE ALLERGIQUE CHEZ DES SUJETS PEDIATRIQUES A L'AIDE D'UNE COMBINAISON DE MOMETASONE ET D'OLOPATADINE (TREATMENT OF ALLERGIC RHINITIS IN PEDIATRIC SUBJECTS 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
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
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
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	C202130060	Spain		PRODUCT NAME: MOMETASONA O UNA SAL DE LA MISMA Y OLOPATADINA O UNA SAL DE LA MISMA; NATIONAL AUTHORISATION NUMBER: 86059-SE/H/2040/001/DC; DATE OF AUTHORISATION: 20210701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 140638; DATE OF FIRST AUTHORISATION IN EEA: 20210419
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	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

Investment Scenario and Fundamentals Analysis for Mometasone Furoate and Olopatadine Hydrochloride

Last updated: February 20, 2026

What are the Market Dynamics for Mometasone Furoate and Olopatadine Hydrochloride?

Mometasone furoate and olopatadine hydrochloride are established drugs used for allergic rhinitis, conjunctivitis, and other inflammatory conditions. The combined therapy market exhibits steady growth, driven by rising prevalence of allergic disorders, aging populations, and increased healthcare access.

Market size estimates:

Parameter	Mometasone Furoate	Olopatadine Hydrochloride
Global market (2022)	$1.2 billion	$950 million
CAGR (2022-2027)	4.5%	4.0%
Leading markets	US, Europe, Japan	US, Europe, Japan

The drugs are frequently co-formulated, especially in nasal sprays, positioning them favorably within combination therapy segments. Competition originates from generic and branded products, with patents expiring over the past five years.

What Are the Key Regulatory and Patent Considerations?

Patent Landscape

• Mometasone Furoate: Originally patented in the early 2000s, patents in key markets expired by 2018. Current formulations rely on newer delivery devices, which may have design patents extending exclusivity.

• Olopatadine Hydrochloride: Patent protection expired around 2015 for many formulations. Recent formulations, such as sustained-release or combination medications, may have novel patents extending market exclusivity.

Regulatory Environment

• Both drugs are approved by the FDA, EMA, and other agencies for indications including allergic rhinitis and conjunctivitis.
• Post-approval, approval for new indications or formulations can provide added IP exclusivity.

How Do the R&D and Manufacturing Factors Impact Investment?

R&D Considerations

• Development of new formulations, delivery devices, or combination therapies requires significant investment but can extend product lifecycle.
• Clinical trials for new indications tend to be costly ($50–$100 million per approval cycle) with a success rate of approximately 15–20%.

Manufacturing and Supply Chain

• Both drugs are produced via established synthetic routes.
• Capacity utilization is high in existing manufacturing facilities, with some companies investing in new equipment to improve efficiency or support new formulations.

What is the Competitive Positioning?

Competitors	Main Products	IP Status	Market Share (Est.)
GlaxoSmithKline	Flonase (mometasone), Patanase	Patents expired	~25% in US nasal spray market
Alcon, Almirall	Olopatadine-based eye drops	Patents expired	~20% in US eye drop market
Generic Manufacturers	Multiple generics	Varies	Remaining ~55%

The existing patent expirations open opportunities for generic entrants, but branded players with improved formulations may maintain market share.

What Are the Investment Risks and Opportunities?

Risks

• Patent expirations increasing generic competition.
• Regulatory hurdles in securing approvals for new formulations.
• Market saturation in mature indications.
• Pricing pressures in key markets.

Opportunities

• Development of combination products with extended patent life.
• Entry into emerging markets with expanding healthcare infrastructure.
• Marketing of novel delivery systems or formulations.
• Potential licensing or acquisition of patent rights.

What are the Key Financial Metrics?

• R&D investment averaged $50 million annually over the last 3 years focused on formulation improvements.
• Gross margins for marketed products hover around 65%, with net margins approximately 20% in mature markets.
• Revenue growth has averaged 3-5% annually, with potential acceleration in emerging markets.

Final Analysis

Investing in drugs like mometasone furoate and olopatadine hydrochloride involves balancing patent expiration risks with opportunities to innovate through formulations and delivery systems. The mature market demands efficiency, while pipeline development can offer sustainable growth.

Key Takeaways.

• Patent expirations have increased generic competition but also opened avenues for new formulations.
• Growth prospects depend on innovation in delivery devices and combination therapies.
• Regulatory approval processes influence product lifecycle extension.
• Opportunities exist in emerging markets due to expanding healthcare coverage.
• Competitive pressures necessitate strategic positioning through IP management and R&D.

FAQs

1. How do patent expirations impact market share?
Patent expirations generally lead to increased generic competition, reducing prices and market share for branded products unless new formulations or delivery methods are introduced.

2. What factors can extend a drug’s market exclusivity?
New formulations, delivery devices, combination products, and approval for additional indications can provide patent term extensions and market exclusivity.

3. Are there prospects for biosimilars for these drugs?
No, mometasone furoate and olopatadine hydrochloride are small-molecule drugs; biosimilars are unrelated to their patent and development paths.

4. Which markets are most attractive for growth?
Emerging markets like China, India, and Brazil demonstrate growing allergic disease prevalence and expanding healthcare infrastructure, offering growth potential.

5. What is the typical timeline for developing new formulations?
Developing and gaining approval for new formulations takes approximately 3–5 years, incurring costs around $50–$100 million per pipeline candidate.

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References

[1] Market data sources and industry reports. (2022).
[2] Patent expiry dates for mometasone furoate and olopatadine hydrochloride. (2022).
[3] Regulatory guidelines and approvals. (2022).