PATADAY TWICE DAILY RELIEF Drug Patent Profile

When do Pataday Twice Daily Relief patents expire, and what generic alternatives are available?

Pataday Twice Daily Relief is a drug marketed by Alcon Labs Inc and is included in one NDA.

The generic ingredient in PATADAY TWICE 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 Twice Daily Relief

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

Summary for PATADAY TWICE DAILY RELIEF

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	7
Patent Applications:	1,879
DailyMed Link:	PATADAY TWICE DAILY RELIEF at DailyMed

Recent Clinical Trials for PATADAY TWICE 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 TWICE DAILY RELIEF clinical trials

Pharmacology for PATADAY TWICE 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 TWICE DAILY RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY TWICE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.1%	020688	1	2006-07-17

US Patents and Regulatory Information for PATADAY TWICE DAILY RELIEF

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 TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996		OTC	Yes	Yes

Expired US Patents for PATADAY TWICE DAILY RELIEF

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	4,871,865
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,641,805*PED

International Patents for PATADAY TWICE DAILY RELIEF

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

Country	Patent Number	Title	Estimated Expiration
Hungary	T41761
Norway	311637
Mexico	9701013	FORMULACIONES OFTALMICOS TOPICAS QUE CONTIENEN DERIVADOR DE DOXEPINA PARA TRATAMIENTO DE ENFERMEDADES OCULARES ALERGICAS. (TOPICAL OPHTHALMIC FORMULATIONS CONTAINING DOXEPIN DERIVATIVES FOR TREATING ALLERGIC EYE DISEASES.)

Supplementary Protection Certificates for PATADAY TWICE DAILY RELIEF

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
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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

Market Dynamics and Financial Trajectory for Pataday Twice Daily Relief

Last updated: February 28, 2026

What is Pataday Twice Daily Relief?

Pataday Twice Daily Relief is an over-the-counter (OTC) antihistamine ophthalmic solution primarily used to treat symptoms of allergic conjunctivitis. The product contains olopatadine, a selective antihistamine that suppresses allergic responses in the eyes. It is marketed by Alcon and approved by the FDA for twice-daily application.

Market Size and Growth Drivers

Global Ophthalmic Allergens Market

The global ophthalmic allergy treatment market was valued at approximately $2.2 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6% over the next five years, reaching around $3.0 billion by 2026. The segment includes antihistamines, mast cell stabilizers, and combination therapies.

Key Factors Fueling Growth

• Increasing prevalence of allergic conjunctivitis: Affects up to 25% of the global population, driven by urbanization, pollution, and climate change.
• Rising awareness: Growing recognition of allergy treatments among patients and healthcare providers.
• OTC availability: Regulatory approval for over-the-counter status increases accessibility and consumer adoption.
• Product efficacy and safety: Pataday’s once-daily and twice-daily formulations have demonstrated favorable safety profiles.

Competitive Landscape

Major competitors include:

• Alcon's Pataday (olopatadine)
• Allergan's Lastacort (ketotifen)
• Merck's Zaditor (ketotifen)
• Novartis' nasal sprays and combined products

Market share distribution favors Pataday due to strong brand recognition, physician recommendation, and OTC status in major markets.

Revenue and Financial Trends

Revenue Estimates

Alcon's ophthalmic allergy products, including Pataday, generated estimated revenues of $235 million in 2022, representing approximately 11% of Alcon's global ophthalmology sales.

Year	Estimated Revenue (USD millions)	Notes
2020	185	Pre-pandemic baseline
2021	210	Recovery post-COVID disruptions
2022	235	Steady growth, market expansion

Revenue Drivers

• Increased OTC SKU penetration in North America and Europe.
• Expansion into emerging markets.
• Potential introduction of new formulations or combinations.

Profitability and Cost Structure

Profit margins for OTC ophthalmic products like Pataday usually range between 50-70%, driven by minimal manufacturing costs and high brand loyalty. The cost of goods sold (COGS) is approximately 20% of revenue, with marketing and distribution accounting for the remainder.

Market Dynamics

Regulatory Environment

Pataday has obtained OTC approval in the U.S., Canada, and several European countries. Regulatory pathways for similar products involve demonstrating safety and efficacy through clinical trials and post-market surveillance.

Pricing Strategy

In the U.S., OTC eye drops like Pataday are priced between $15-$25 per 0.5 oz bottle, depending on retailer and dosage. Price elasticity remains moderate, with consumers willing to pay for perceived effectiveness.

Distribution Channels

Primary channels include:

• Pharmacies (drug, grocery, big-box)
• Online retail platforms
• Physician offices (prescription renewals initially, now OTC)

Distribution strategies focus on maximizing retail presence and e-commerce access due to increasing online shopping.

Challenges

• Competition from generics and private label brands.
• Patient adherence to twice-daily dosing.
• Regulatory changes affecting OTC availability or labeling.
• Potential safety concerns in specific populations.

Financial Trajectory Outlook

Short-term (1-3 years)

• Expect continued revenue growth driven by market expansion and brand loyalty.
• Launch of improved formulations or variants could drive additional sales.
• Marketing investments will sustain consumer awareness.

Medium-term (3-5 years)

• Market saturation in developed countries may moderate growth.
• Expansion into emerging markets can boost revenues.
• Potential for data licensing or partnership deals with global distributors.

Long-term (5+ years)

• Patent expirations are unlikely as Pataday's formulation is established; however, exclusivities granted in new markets or formulations can prolong competitiveness.
• Market consolidation or emergence of innovative therapies could impact growth.
• Consumer preference shifts towards prescription alternatives or new treatment modalities.

Strategic Considerations

• Patent Protection: Pataday's patents on formulations expired in many jurisdictions, increasing risk of generics entering the market.
• Innovation: Development of long-acting or combination products may sustain relevance.
• Regulatory Environment: monitoring potential changes in OTC classifications or formulary updates.

Key Takeaways

• Pataday Twice Daily Relief operates in a growing ophthalmic allergy market driven by increasing allergic conjunctivitis prevalence.
• Revenues are primarily generated through OTC sales, with a stable competitive position.
• The financial trajectory indicates steady growth, with opportunities in emerging markets and potential product diversification.
• Market challenges include price competition, patent expiration, and evolving regulatory policies.

FAQs

1. How does Pataday’s market position compare to competitors?

Pataday holds a leading position in OTC ophthalmic allergy treatments due to strong brand recognition, efficacy, and OTC availability. Competitors like Zaditor and generic ketotifen products offer lower prices, but Pataday's established reputation maintains its market share.

2. What are the risks associated with Pataday's financial trajectory?

Patent expirations and increased generic competition could pressure pricing and margins. Regulatory changes affecting OTC status could also impact sales. Market saturation in developed regions may slow growth.

3. What growth opportunities exist for Pataday?

Expansion into emerging markets, development of longer-acting formulations, and potential licensing deals can drive growth. Raising consumer awareness through marketing also supports sales.

4. How significant is the OTC regulatory environment for Pataday?

Regulatory approval as an OTC product expands accessibility but also subjects the product to stricter safety labeling and post-market surveillance. Changes in OTC policies could influence sales volume.

5. What is the outlook for the industry in the next five years?

The ophthalmic allergy market is expected to grow at a CAGR of 6%, supported by rising allergy prevalence and OTC product acceptance. Innovation and regional expansion are key drivers.

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References

1. Market Research Future. (2022). Ophthalmic Allergy Market Research Report.
2. Alcon Reports. (2022). Annual Financial Statements.
3. U.S. Food and Drug Administration. (2022). List of OTC Drug monographs.
4. Statista. (2022). Global Allergic Conjunctivitis Prevalence.
5. Grand View Research. (2022). Ophthalmic Drugs Market Size & Trends.