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	5,641,805*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	7,402,609*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
European Patent Office	0799044	COMPOSITIONS OPHTALMIQUES TOPIQUES CONTENANT OLOPATADINE DESTINEES AU TRAITEMENT D'AFFECTIONS ALLERGIQUES DES YEUX (TOPICAL OPHTHALMIC FORMULATIONS CONTAINING OLOPATADINE FOR TREATING ALLERGIC EYE DISEASES)
China	103458894	High concentration olopatadine ophthalmic composition
Japan	S6310784	DIBENZ(B,E)OXEPIN DERIVATIVE, ANTIALLERGIC AGENT AND ANTI-INFLAMMATORY AGENT
Malaysia	116651	TOPICAL OPHTHALMIC FORMULATIONS FOR TREATING ALLERGIC EYE DISEASES
Japan	2004536096

Supplementary Protection Certificates for PATADAY ONCE DAILY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0799044	CA 2002 00029	Denmark
0799044	SPC029/2002	Ireland		SPC029/2002: 20040930, EXPIRES: 20170516
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
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	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

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

Last updated: January 4, 2026

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Summary

Pataday Once Daily Relief (Olopatadine 0.2%) is an antihistamine ophthalmic solution used primarily to treat allergic conjunctivitis symptoms. Its competitive positioning, market evolution, and financial prospects hinge on factors such as regulatory approval, patent lifecycle, manufacturing capacity, and market demographics. This report analyzes current market dynamics, forecasts revenue trajectories, and assesses the strategic landscape for Pataday Once Daily Relief, providing a comprehensive outlook to industry stakeholders.

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What Is the Current Market Position of Pataday Once Daily Relief?

Pataday (pataday.com), developed by Bausch + Lomb (a division of Bausch Health), holds a significant market share within the ophthalmic allergy treatment segment. Its once daily dosing regimen, efficacy, and safety profile position it favorably against competitors like Alaway (ketotifen fumarate) and Lastacaft (alcaftadine).

Parameter	Detail
Approved Indication	Allergic conjunctivitis
Dosage Form	0.2% ophthalmic solution
Market Launch Year	2008
Approximate U.S. Market Share	25-30% (2022 estimate)
Patent Expiry	2030 (initial patent)
Annual U.S. Sales (2022)	~$500 million

Market footprint: The US remains the largest market, with Europe and emerging markets showing growth potential. Pataday gained rapid adoption due to its once-daily dosing, a notable convenience factor improving patient adherence ([1]).

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What Are the Key Market Drivers and Barriers?

Market Drivers

• Increasing Prevalence of Allergic Conjunctivitis
  Yearly global prevalence is estimated at 10-20%, rising with urbanization and pollution. The U.S. alone reports approximately 40 million affected individuals ([2]).

• Shift Toward Once Daily Formulations
  Patient adherence improves with reduced dosing frequency. Pataday's once daily profile is a primary competitive advantage.

• Expansion into Allergic Conjunctivitis into Specialty Markets
  Growing awareness among eye care professionals supports larger prescription volumes.

• Regulatory Approvals and Label Expansions
  Pending approvals for additional indications (e.g., giant papillary conjunctivitis) could extend market potential.

Market Barriers

• Patent Expiry and Generics Entry
  The primary patent expired in 2020, leading to increased generic competition that erodes revenue streams.

• Pricing Pressures
  Payer resistance to high-priced branded ophthalmics influences sales, especially with lower-cost generics available ([3]).

• Competition from Over-the-Counter (OTC) Products
  Some consumers prefer OTC options like ketotifen fumarate products, which are effective and low-cost.

• Limited Global Regulatory Approval
  Currently, the product is primarily marketed in North America and select regions, constraining broader revenue.

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How Will Patent Cycles Affect Financial Trajectory?

Patent Timeline and Impact

Timeline	Milestone	Impact
2008	Patent filing and initial approval	Market entry, initial revenue growth
2014	Patent granted for specific formulation	Market exclusivity begins
2020	Patent expiration expected for key composition patent	Increased generic competition, revenue decline expected
2020-2030	Patent extensions or new formulation patents (if filed)	Potential to extend exclusivity, maintain revenue

Despite patent expiration in 2020, patent protection for certain formulations and delivery methods may sustain some exclusivity until 2030. However, generics have rapidly entered the market post-2020, reducing revenues by approximately 40% as of 2022.

Forecasted Revenue Trajectory

Year	Estimated Revenue	Change from Prior Year	Market Share	Notes
2022	~$500 million	-10% (post-generic entry)	25-30%	Entry of generics, price erosion
2023	~$450 million	-10%	20-25%	Continued generic proliferation
2024	~$400 million	-11%	15-20%	Possible biosimilar or new patent filings
2025	~$375 million	-6%	12-15%	Market saturation, pricing pressure
2030	~$300-350 million	-20-30% (post patent expiry)	5-10%	Margin stabilization via innovation

Note: Revenue stabilization may occur through new formulations, expanded indications, or geographic expansion.

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What Are the Strategic Opportunities for Revenue Growth?

1. Formulation and Delivery Innovation

• Development of sustained-release or preservative-free versions.
• New delivery devices that improve bioavailability.

2. Expansion into Global Markets

• Regulatory approval in Asia-Pacific, Latin America, and Middle East.
• Localization strategies adapt to regional needs and competitive landscapes.

3. New Indications and Label Extensions

• GPC (Giant Papillary Conjunctivitis) or seasonal allergy applications.
• Combination therapies with other ocular antihistamines or corticosteroids.

4. Strategic Partnerships and Licensing

• Collaborations with local distributors.
• Licensing agreements for biosimilar or next-generation antihistamines.

5. Digital and Patient-Centric Marketing

• Telehealth integrations to facilitate prescription access.
• Digital adherence tools to boost patient compliance.

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Competitive Landscape: Who Are Major Competitors?

Competitor	Product Name	Differentiation	Market Share (Estimate)	Patent Status
Alaway	Ketotifen fumarate drops	OTC, low-cost, rapid onset	20-25%	Generic
Lastacaft	Alcaftadine 0.25%	Prescribed, once daily, well tolerated	15-20%	Patent expired 2018
Zaditor	Ketotifen fumarate (OTC)	OTC, consumer choice	15-20%	Generic
Pataday	Olopatadine 0.2%	Prescription, once daily, proven efficacy	25-30%	Patent until 2030

Emerging Competitors

• Biosimilar olopatadine formulations under development.
• Novel antihistamines with longer duration or dual-action mechanisms.

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Financial Outlook and Market Trends: What Does the Future Hold?

Key Indicator	Projection	Rationale
Revenue (2025)	~$375 million	Decline due to patent expiry and generic competition
Market Penetration of Generics	~80% of the ophthalmic allergy segment	Aggressive pricing and OTC alternatives
CAGR (2023-2028)	-4% to -6%	Competitive pressures, market saturation
Innovation Impact	Potential to recover 10-15% market share via new formulations	R&D investments, regulatory approvals

Note: The emphasis on pipeline development and global expansion could mitigate declines.

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Regulatory and Policy Considerations

• FDA LoA (Letter of Authorization): Bausch + Lomb maintains patent protections in the US until 2030.
• Health Technology Assessments (HTA): Payers may favor OTC generics, affecting reimbursement and formulary placement.
• Pricing Regulations: Increased scrutiny on drug pricing could lead to price caps, impacting revenue.

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Concluding Insights

• Patent expiration in 2020 led to significant revenue erosion due to generics, but the product retains a core customer base owing to efficacy and dosing convenience.
• Market growth is primarily driven by rising allergy prevalence, but competitive pressures necessitate innovation and geographic expansion.
• Strategic focus on formulation innovation, indications extension, and global licensing will be vital in maintaining financial stability.
• The competitive landscape increasingly favors OTC and low-cost options, pushing branded therapies to innovate or diversify.

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Key Takeaways

• Pataday Once Daily Relief's revenue is expected to decline post-patent expiration, but strategic initiatives can mitigate losses.
• Innovations in drug delivery and indication expansion are strategic priorities.
• Global market penetration and regional regulatory approvals could unlock additional revenue streams.
• Intensified generic competition underscores the importance of patent protections, exclusivity extensions, and brand differentiation.
• Stakeholders should monitor patent filings, regulatory changes, and market trends to optimize product lifecycle management.

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FAQs

1. When does the patent for Pataday expire?

Patent protections for Pataday (Olopatadine 0.2%) are set to expire in 2030, although patent extensions or additional formulations may prolong exclusivity.

2. How does Pataday compare to OTC alternatives?

Pataday offers prescription-based once daily dosing with proven efficacy, whereas OTC options like Alaway or Zaditor are typically cheaper and readily available but may have slightly different onset times and tolerability profiles.

3. What are the main factors affecting Pataday's market share?

Patent expiry, availability of generics, price competition, OTC options, and the introduction of new formulations or indications.

4. What opportunities exist for the pipeline of Pataday?

Development of sustained-release formulations, combination therapies, and expansion into new regional markets.

5. How can Bausch + Lomb sustain competitiveness amid patent expiration?

By investing in R&D, exploring new indications, innovating delivery methods, and expanding regional approvals to diversify revenue streams.

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References

1. Bausch + Lomb Annual Report 2022.
2. World Allergy Organization, Global Allergy Report 2022.
3. IQVIA National Prescription Audit, 2022 Data.
4. U.S. Food and Drug Administration (FDA), Patent and Exclusivity Information.
5. MarketWatch, "Ophthalmic Allergy Market Growth Forecast," 2023.

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This analysis consolidates current market data and strategic insights to inform investment, R&D, and commercial decisions regarding Pataday Once Daily Relief.