PATADAY ONCE DAILY RELIEF Drug Patent Profile

Which patents cover Pataday Once Daily Relief, and when can generic versions of Pataday Once Daily Relief launch?

Pataday Once Daily Relief is a drug marketed by Alcon Labs Inc and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-two patent family members in twenty countries.

The generic ingredient in PATADAY ONCE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pataday Once Daily Relief

A generic version of PATADAY ONCE DAILY RELIEF was approved as olopatadine hydrochloride by APOTEX INC on October 8^th, 2014.

Summary for PATADAY ONCE DAILY RELIEF

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	7
Patent Applications:	1,879
What excipients (inactive ingredients) are in PATADAY ONCE DAILY RELIEF?	PATADAY ONCE DAILY RELIEF excipients list
DailyMed Link:	PATADAY ONCE DAILY RELIEF at DailyMed

Recent Clinical Trials for PATADAY ONCE DAILY RELIEF

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Allergan	Phase 4
McCabe Vision Center	N/A

See all PATADAY ONCE DAILY RELIEF clinical trials

Pharmacology for PATADAY ONCE DAILY RELIEF

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

Paragraph IV (Patent) Challenges for PATADAY ONCE DAILY RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.7%	206276	1	2015-09-10
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.2%	021545	1	2008-09-08

US Patents and Regulatory Information for PATADAY ONCE DAILY RELIEF

PATADAY ONCE DAILY RELIEF is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004		OTC	Yes	Yes
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	8,791,154		Y
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 PATADAY ONCE DAILY RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	7,402,609*PED
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	6,995,186*PED
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,641,805*PED

International Patents for PATADAY ONCE DAILY RELIEF

See the table below for patents covering PATADAY ONCE DAILY RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	340957	COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.)
China	1211125
World Intellectual Property Organization (WIPO)	2012159064
South Korea	20200053635	고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)
Colombia	6801738	Composición oftálmica de alta concentración de olopatadina
Russian Federation	2613715	ОФТАЛЬМОЛОГИЧЕСКАЯ КОМПОЗИЦИЯ С ВЫСОКОЙ КОНЦЕНТРАЦИЕЙ ОЛОПАТАДИНА (OPHTHALMIC COMPOSITION WITH HIGH CONCENTRATION OF OLOPATADINE)

Supplementary Protection Certificates for PATADAY ONCE DAILY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0799044	SPC029/2002	Ireland		SPC029/2002: 20040930, EXPIRES: 20170516
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
0799044	CA 2002 00029	Denmark
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
0799044	SPC/GB02/041	United Kingdom		SPC/GB02/041: 20021018

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Pataday Once Daily Relief

Last updated: July 30, 2025

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Introduction

Pataday Once Daily Relief, a topical ophthalmic formulation primarily used for allergy symptom management, exemplifies a significant segment within the broader allergy and ophthalmology markets. Its development, marketing strategies, regulatory landscape, competitive positioning, and future growth potential shape its financial trajectory. Analyzing these factors provides crucial insights for stakeholders considering investments, partnerships, or market entry strategies in this niche pharmaceutical domain.

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Product Overview

Pataday Once Daily Relief (olopatadine hydrochloride ophthalmic solution 0.1%) is indicated for the relief of ocular itching associated with allergic conjunctivitis. Its once-daily dosing offers convenience, driving its preference among patients and clinicians. Marketed by Alcon (a Novartis unit), the formulation's efficacy, safety profile, and adherence benefits have fostered market penetration since its launch.

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Market Landscape and Dynamics

Global Allergy and Ophthalmology Markets

The allergy treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing prevalence of allergic conjunctivitis and awareness campaigns[1]. The ophthalmic segment, encompassing anti-allergy and anti-inflammatory drugs, represents a lucrative sub-market valued at over USD 15 billion globally, with eye allergy treatments accounting for a significant share.

Drivers of Market Growth

• Rising Prevalence of Allergic Conjunctivitis: Affecting approximately 15-20% of the global population, allergy-related ocular conditions are expanding due to urbanization, pollution, and climate change[2].
• Advancements in Treatment Options: Improved formulations like Pataday Once Daily Relief capitalize on patient preference for convenience and minimal side effects.
• Increasing Awareness and Improved Diagnostic Capabilities: Better identification of allergic conjunctivitis supports higher treatment rates.
• Aging Population: Elderly demographics are more susceptible to ocular allergies, expanding the age-based market.

Competitive Environment

Pataday faces competition from multiple classes of allergy ophthalmic medications, including:

• Mast Cell Stabilizers: Olopatadine (generic and branded), ketotifen
• H1-Antihistamines: Azelastine, epinastine
• Combination Products: Dual-acting formulations combining antihistamines and mast cell stabilizers

Key competitors include Alimera Sciences’ Alrex and Visine Similar formulations, emphasizing patent status, differentiated dosing, and patient adherence.

Regulatory and Reimbursement Dynamics

Regulatory approvals worldwide influence market accessibility. Pataday's registration in major markets like the U.S., EU, and emerging regions has propelled its sales. Reimbursement policies and formularies, especially in developed healthcare systems, significantly impact market penetration and revenue streams.

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Financial Trajectory Analysis

Historical Performance

Since its launch, Pataday Once Daily Relief has demonstrated steady growth:

• Sales Volume: Increasing penetration in North America and Europe, driven by effective marketing and physician preference.
• Revenue Trends: Estimated sales surpass USD 200 million annually globally, with North America accounting for approximately 70% of revenues[3].

Pricing Strategy and Revenue Streams

Pricing strategies position Pataday as a premium, branded medication, benefiting from its once-daily dosing convenience. Reimbursement schemes enhance affordability, thus broadening patient access.

Future Growth Projections

• Market Expansion: Growing awareness and entry into emerging markets could increase sales volumes by 10-15% annually.
• Pipeline and Line Extensions: Introduction of combination therapies or same-class formulations may diversify revenue streams.
• Patent Landscape: Patent exclusivity until approximately 2024–2025 offers temporary pricing and market advantage. Post-expiry, generic competition threatens price erosion but also opens volume-based growth opportunities.

Risks Impacting Financial Trajectory

• Patent Expiry and Generic Competition: The impending loss of exclusivity could precipitate price competition, compressing margins.
• Regulatory Changes: Stringent approval processes or unfavorable reimbursement policies could limit market access.
• Market Saturation: High penetration in core markets might plateau sales unless expanding geographically or innovating formulations.

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Strategic Implications and Opportunities

• Market Diversification: Entering Asian, Latin American, and African markets offers substantial growth potential amid rising allergy prevalence.
• Product Differentiation: Enhancing dosing convenience, combination formulations, or novel delivery mechanisms could sustain competitive advantages.
• Partnerships and Alliances: Licensing deals or co-promotion with local players can accelerate expansion.
• R&D Investment: Developing next-generation formulations with improved efficacy or fewer side effects can extend product lifecycle.

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Conclusion

Pataday Once Daily Relief’s market dynamics are shaped by escalating allergy prevalence, innovative product positioning, and competitive pressures within the ophthalmology segment. Its financial trajectory appears promising in the medium term, contingent on strategic management of patent cliffs and market expansion efforts. Stakeholders must closely monitor patent exclusivity timelines, competitive developments, regulatory environments, and consumer preferences, to sustain growth and maximize value.

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Key Takeaways

• The global allergy and ophthalmology markets are expanding, underpinning Pataday’s growth potential.
• Patent expiration and generic entry pose significant risks but can be mitigated by product innovation and market expansion.
• Strategic geographical diversification and pipeline development are vital to prolong product lifecycle and revenue growth.
• Reimbursement policies and payer dynamics are critical in shaping access and profitability.
• Continuous monitoring of competitive and regulatory environments is essential for maintaining market position.

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Frequently Asked Questions

1. When does Pataday’s patent protection expire, and what impact will patent loss have?
Pataday’s key patents are expected to expire around 2024–2025, after which generic competition is likely to increase, potentially reducing prices and margins. Strategic product line extensions and geographical expansion represent countermeasures.

2. How does Pataday compare to its generic counterparts?
Pataday’s primary advantage is its once-daily dosing and proven efficacy with a favorable safety profile. Generics may offer lower prices but might lack some of the convenience and brand recognition advantages.

3. Are there significant opportunities in emerging markets for Pataday?
Yes. Rising allergy rates, growing healthcare infrastructure, and increasing awareness create substantial opportunities in Asia, Latin America, and Africa, provided regulatory and reimbursement barriers are addressed.

4. What are the key competitive threats facing Pataday?
Main threats include patent expiration leading to generics, entry of new formulations with improved efficacy, and expanding competition from other antihistamine or combination therapies.

5. What are potential avenues for innovation to extend Pataday’s market lifecycle?
Developing combination products, exploring alternative delivery systems (e.g., sustained-release eye drops), and expanding indications could provide differentiation and sustain growth.

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References

1. MarketsandMarkets. (2022). Allergy Treatment Market Forecast.
2. Global Allergy and Asthma Report. (2021). Prevalence Data.
3. Company Financial Reports. (2022). Novartis/Alcon Sales Data.