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

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

Constraining patent/regulatory exclusivity:

10,765,686

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	11,679,210		Y
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	11,400,101
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,016,443
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	9,370,483		Y
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	10,758,550

International Patents for mometasone furoate; olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2021514947	モメタゾン及びオロパタジンの組み合わせを用いた小児対象におけるアレルギー性鼻炎の治療
South Korea	20200125625
Japan	2016534142	モメタゾン及びオロパタジンを有する安定な定用量薬剤組成物
Croatia	P20202048
China	112773808	使用莫米松和奥洛他定的组合治疗过敏性鼻炎 (Treatment of allergic rhinitis using combination of mometasone and olopatadine)
Canada	3023355	DISPOSITIF DISTRIBUTEUR ET COMPOSITION PHARMACEUTIQUE DESTINES AU TRAITEMENT DE LA RHINITE (DISPENSING DEVICE AND PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF RHINITIS)
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

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	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	122021000085	Germany		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: 2205824.00.00 20211117; FIRST REGISTRATION: OESTERREICH 140638 20210426
3043773	57/2021	Austria		PRODUCT NAME: MOMETASON ODER EIN SALZ DAVON UND OLOPATADIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: 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	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410

Mometasone furoate; olopatadine hydrochloride Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Current Market Dynamics for Mometasone Furoate and Olopatadine Hydrochloride?

The global demand for mometasone furoate and olopatadine hydrochloride stems from their widespread use in allergy and dermatological therapies. Market growth is driven by increasing prevalence of allergic rhinitis, asthma, and dermatological conditions, with approvals expanding to new formulations and regions.

In 2022, the pharmaceutical market for mometasone furoate was valued at approximately $1.2 billion, expected to grow at a CAGR of 5.8% from 2023 to 2030. Olopatadine hydrochloride's market was valued at around $0.9 billion in 2022, with forecasts predicting a CAGR of 6.2%.

Key factors influencing market dynamics include regulatory approvals, patent status, and generic entry. Both drugs are marketed as nasal sprays, topical ointments, or eye drops. Their patent expirations, notably for olopatadine, have facilitated an influx of generic manufacturers, increasing competition and pressuring prices.

Geographic trends see North America and Europe as leading markets, driven by high healthcare expenditure and awareness. Asia-Pacific region shows rapid growth potential due to increasing healthcare infrastructure and local manufacturing.

What Is the Financial Trajectory for These Drugs?

Mometasone Furoate

• Patent expiry for key formulations has occurred around 2018–2019, leading to a surge in generics.
• Brand-name drugs such as Nasonex hold premium pricing but face declining market share due to generics.
• Revenue is shifting from branded products to generics; top manufacturers like Merck and Teva have expanded their generic portfolios.
• Expected revenues in 2023 are around $1 billion, with a gradual decline in brand sales but growth maintained via generic proliferation.

Olopatadine Hydrochloride

• Patent expiry occurred in 2018 for some formulations; recent patents cover specific formulations extending until 2025–2027.
• Leading brands include Allergan's Pataday, but generics are gaining market share rapidly.
• Revenue in 2022 was approximately $900 million; forecasts indicate a plateau due to market saturation, but ongoing growth is possible through new formulations or combination products.
• Generic market introduction has driven down prices, impacting revenue margins for brand-name drugs.

Financial Trends & Investment Outlook

• The move toward over-the-counter (OTC) status for certain formulations (e.g., olopatadine eye drops in some regions) could expand market share.
• R&D investments focus on combination therapies and novel delivery mechanisms to extend patent life and differentiate products.
• Expansion into emerging markets and formulation innovations are primary strategies for maintaining revenue streams amid patent expirations.

What Are the Regulatory and Patent Challenges?

Regulatory Environment

• Both drugs are approved by major authorities (FDA, EMA).
• Shifts in regulatory policies favor rapid approval for generic versions post-patent expiry.
• Some formulations qualify for OTC status, reducing regulatory barriers and broadening access.

Patent Landscape

• Mometasone furoate's patents expired in multiple markets, enabling generics since 2019.
• Olopatadine's key patents will expire between 2025 and 2027; ongoing patent filings aim to extend exclusivity via new formulations.
• Patent litigations and patent thickets complicate generic entry in certain jurisdictions.

Which Market Segments or Regions Drive Growth?

Segmental Drivers

• Nasal sprays account for the majority of sales.
• Eye drops, notably olopatadine-based products, show steady growth.
• Topical formulations are gaining traction for dermatological indications.

Regional Drivers

• North America leads, with around 60% of global revenue.
• Europe constitutes approximately 25% of the market.
• Asia-Pacific shows high growth potential with CAGR exceeding 7%, driven by population growth, increased healthcare access, and local manufacturing.

What Are the Competitive Strategies?

• Companies invest in switching drugs to OTC status to capitalize on broader consumer markets.
• Cost leadership through generic manufacturing further accelerates market penetration.
• Drug delivery innovations, such as novel nasal or ocular delivery systems, aim to extend patent protection and improve patient adherence.
• Strategic mergers and acquisitions consolidate market share, especially among generic manufacturers.

Key Takeaways

• Patent expirations have significantly shifted revenue models for mometasone furoate and olopatadine hydrochloride.
• Generics dominate the landscape, pressuring prices for brand-name products.
• Growth opportunities exist in emerging markets, OTC switches, and new formulations.
• Investment is focused on patent extensions, delivery technologies, and expanding indications.
• Regulatory landscapes favor rapid generic adoption post-patent expiry, influencing market shares.

FAQs

1. When did patents for mometasone furoate and olopatadine hydrochloride expire?
   Mometasone furoate patents expired around 2018–2019 in most markets. Olopatadine patents expired between 2018 and 2027 depending on formulation and jurisdiction.

2. What are the main therapeutic indications for these drugs?
   Mometasone furoate treats allergic rhinitis, asthma, and dermatitis. Olopatadine hydrochloride is used for allergic conjunctivitis, allergic rhinitis, and ocular allergies.

3. Which regions represent the largest markets?
   North America accounts for roughly 60% of the revenue, followed by Europe with 25%, and Asia-Pacific with high growth potential.

4. How have patent expirations affected brand sales?
   Patent expirations led to increased generic competition, reducing brand-name prices and revenues, while total market volume remains stable or grows due to higher accessibility.

5. What future innovations could impact the market?
   Novel delivery systems, combination therapy formulations, and expanding OTC availability are key areas influencing future market dynamics.

References

1. MarketWatch. (2023). "Pharmaceutical Market Size Data."
2. IQVIA. (2022). "Global Trends in Allergic Rhinitis Treatments."
3. FDA. (2023). "Drug Patent Expirations and Market Impact."
4. EvaluatePharma. (2023). "Revenue Projections for Nasal and Ophthalmic Drugs."
5. GlobalData. (2023). "Regional Market Forecasts for Allergy and Dermatology Drugs."