Olopatadine hydrochloride - Generic Drug Details

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

Olopatadine hydrochloride is the generic ingredient in four branded drugs marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in thirty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has thirty-two patent family members in twenty countries.

There are fourteen drug master file entries for olopatadine hydrochloride. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for olopatadine hydrochloride

International Patents:	32
US Patents:	2
Tradenames:	4
Applicants:	21
NDAs:	32
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	43
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olopatadine hydrochloride
What excipients (inactive ingredients) are in olopatadine hydrochloride?	olopatadine hydrochloride excipients list
DailyMed Link:	olopatadine hydrochloride at DailyMed

Recent Clinical Trials for olopatadine hydrochloride

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

Sponsor	Phase
MEDA Pharma GmbH & Co. KG	Phase 2
Laboratorios Poen	Phase 4
Michael Marchand, MD	Phase 4

See all olopatadine hydrochloride clinical trials

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.1%	SOLUTION; OPHTHALMIC
		0.2%	SOLUTION;OPHTHALMIC
		0.1%	SOLUTION;OPHTHALMIC

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 olopatadine hydrochloride

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

Medical Subject Heading (MeSH) Categories for olopatadine hydrochloride

Anti-Allergic Agents

Anti-Inflammatory Agents, Non-Steroidal

Histamine H1 Antagonists, Non-Sedating

Anatomical Therapeutic Chemical (ATC) Classes for olopatadine hydrochloride

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

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

Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.7%	206276	1	2015-09-10
PATANASE	Nasal Spray	olopatadine hydrochloride	0.665 mg/ Spray	021861	1	2009-06-29
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.2%	021545	1	2008-09-08
PATADAY TWICE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.1%	020688	1	2006-07-17

US Patents and Regulatory Information for olopatadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206046-001	Jul 26, 2017		OTC	No	No
Usv	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	203152-001	Dec 7, 2015		OTC	No	No
Alembic	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209420-001	Apr 29, 2019		OTC	No	No
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996		OTC	Yes	Yes
Eugia Pharma	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209995-001	Apr 4, 2019		OTC	No	No
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	9,533,053		Y

Expired US Patents for olopatadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,116,863*PED
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,116,863*PED
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,641,805*PED
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	5,116,863*PED
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	7,402,609*PED

International Patents for olopatadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	201249437	High concentration olopatadine ophthalmic composition
Argentina	124659	COMPOSICIÓN OFTÁLMICA DE OLOPATADINA DE ALTA CONCENTRACIÓN
Mexico	2013010039	COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.)
Chile	2013002467	Composición oftálmica que comprende al menos 0,67% pero no más de 1,0% p/v de olopatadina disuelta en solucion, peg con un peso molecular de 300 a 500, polivinilpirrolidona, hidroxialquil ß-ciclodextrina, hidroxialquil ?-ciclodextrina o su combinación y cloruro de benzalconio; gotario que comprende a la composición oftálmica; y su uso en el tratamiento de la conjuntivitis alérgica ocular.
South Korea	20200053635	고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)
Australia	2012255046	High concentration olopatadine ophthalmic composition

Supplementary Protection Certificates for olopatadine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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	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

Market Dynamics and Financial Trajectory for Olopatadine Hydrochloride

Last updated: July 27, 2025

Introduction

Olopatadine hydrochloride is a selective antihistamine primarily indicated for allergic conjunctivitis and seasonal allergic rhinitis. Since its introduction, its unique pharmacological profile and demand for effective allergy relief have positioned it as a significant player in the ophthalmic and respiratory markets. This report analyzes the evolving market landscape, key drivers, competitive forces, regulatory influences, and financial prospects shaping olopatadine hydrochloride’s trajectory.

Market Overview and Current Landscape

Olopatadine hydrochloride is marketed globally through various formulations—ophthalmic solutions, nasal sprays, and oral tablets—capitalizing on increasing allergy prevalence. The global allergy market was valued at approximately USD 23 billion in 2022 and is projected to grow at a CAGR of around 5% through 2030 (source: Grand View Research). Olopatadine’s share within this segment is notable due to its dual antihistaminic and mast cell stabilizing properties, positioning it favorably against alternatives like azelastine and ketotifen.

In 2022, the pharmaceutical segment dedicated to olopatadine’s formulations exceeded USD 1 billion, with significant contributions from North America, Europe, and Asia-Pacific. The inclusion of generic formulations has intensified price competition, impacting revenue streams for innovator brands like Alcon (Pataday) and Almirall (Ocupodine).

Key Drivers of Market Dynamics

Increasing Allergy Prevalence

Rising urbanization, pollution, and climate change are fueling the global rise in allergies, directly increasing demand for effective antihistamines like olopatadine. Pediatric and geriatric populations further expand the user base. The World Allergy Organization estimates that over 30% of the global population suffers from allergic rhinitis, reinforcing sustained market demand.

Product Innovation and Expanded Indications

Innovation in delivery systems—preservative-free eye drops, combination formulations—enhances patient adherence. Regulatory approvals of olopatadine for new indications, such as non-allergic conjunctivitis, bolster the market. For instance, the FDA’s approval of new dosages and formulations in recent years sustains relevance across demographics.

Regulatory and Patent Landscapes

Patent expirations in key markets, notably the US and Europe, have led to an influx of generics, driving down prices but expanding access. However, patent protections on original formulations continue to generate premium revenues, especially in emerging markets where patent enforcement varies.

Competitive Forces

The landscape comprises branded and generic manufacturers, including Teva, Sandoz, Mylan, and local players in Asia and Latin America. Competition intensifies with multiple product entry post-patent expiry, compressing margins but enlarging the overall market size.

Healthcare Policy and Reimbursement

Reimbursement policies favor cost-effective generics, influencing prescribing patterns. In countries with universal healthcare systems, formulary decisions directly impact sales volume and pricing strategies.

Market Challenges

Pricing Pressures and Generic Competition

The widespread availability of low-cost generics has led to significant pricing compression, reducing profit margins for incumbent brands. For example, in the United States, generic olopatadine prices have fallen by over 40% since 2018.

Regulatory Hurdles

Stringent regulatory pathways for new formulations or indications can delay market entry. Variability among jurisdictions complicates global commercialization strategies.

Supply Chain Disruptions

Global supply chain challenges, particularly in active pharmaceutical ingredients (API) sourcing, can disturb production volumes and profitability.

Financial Trajectory and Revenue Projections

Historical Performance

From 2018 to 2022, revenues for olopatadine-based products grew at a CAGR of approximately 8% in established markets, driven by increased allergy awareness and formulation innovations.

Forecast Perspective (2023–2030)

Market analysts project a compound annual growth rate of 6-7% globally, culminating in a market valuation exceeding USD 2.3 billion by 2030. Factors contributing to this include:

• Emerging Market Penetration: Rapid growth in APAC and Latin America, where allergy prevalence is rising and healthcare access expanding.
• Extended Patent Lifespans: Defensive strategies and new formulations potentially extending patent protections.
• Portfolio Expansion: Companies investing in combination therapies and novel delivery methods (e.g., sustained-release formulations) to capture niche segments.

Revenue Segmentation

• Branded Drugs: Maintain premium margins with ongoing innovation.
• Generics: Account for approximately 60-70% of the market share, with rapid growth in volume but lower unit prices.
• OTC Markets: Over-the-counter sales for minor allergic conditions are increasing, driven by consumer demand and OTC regulation liberalization.

Strategic Opportunities

• Formulation Innovation: Development of preservative-free, long-acting formulations enhances compliance and widens markets.
• Combination Products: Pairing olopatadine with corticosteroids or decongestants can address multiple symptoms, expanding indications.
• Geographic Expansion: Focused entry into underpenetrated markets like Africa and Southeast Asia.

Risks and Mitigation Strategies

• Pricing Pressures: Firms should leverage product differentiation and downstream service enhancements.
• Regulatory Delays: Engaging proactively with regulatory agencies and investing in comprehensive clinical data reduce approval timelines.
• Supply Chain Risks: Diversifying suppliers and investing in local manufacturing capacities enhance resilience.

Conclusion

Olopatadine hydrochloride’s market outlook remains robust amid rising allergy prevalence and ongoing innovation. Market dynamics will continue to shape its financial trajectory, emphasizing strategic formulation development, geographic expansion, and competitive positioning. For stakeholders, understanding these evolving variables is essential for capitalizing on growth opportunities while navigating risks.

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Key Takeaways

• The olopatadine hydrochloride market is projected to grow steadily, driven by increasing allergy incidence and formulation innovation.
• Patent expirations have opened opportunities for generics, intensifying price competition but expanding overall market access.
• Formulation and delivery system innovations can create premium segments and enhance patient adherence.
• Expansion into emerging markets is vital, due to rising allergy prevalence and healthcare infrastructure growth.
• Maintaining competitive advantage requires balancing innovation, regulatory compliance, and supply chain resilience.

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FAQs

1. What is the primary therapeutic use of olopatadine hydrochloride?

Olopatadine hydrochloride is mainly used to treat allergic conjunctivitis and seasonal allergic rhinitis by inhibiting histamine release and stabilizing mast cells.

2. How has patent expiry affected the olopatadine market?

Patent expiry has led to a surge in generic formulations, reducing prices and profit margins for original brand manufacturers but expanding overall market volume.

3. What innovations are shaping the future of olopatadine formulations?

Developments include preservative-free eye drops, sustained-release devices, and combination therapies aimed at improving compliance and expanding indications.

4. Which regions offer the most growth potential for olopatadine?

Emerging markets in Asia-Pacific, Latin America, and Africa present significant growth opportunities due to increasing allergy prevalence and expanding healthcare access.

5. What risks could impact olopatadine’s market trajectory?

Key risks include intense price competition from generics, regulatory hurdles, supply chain disruptions, and evolving healthcare policies affecting reimbursements.

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Sources:

[1] Grand View Research. "Allergy Drugs Market Size, Share & Trends Analysis Report." 2022.