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-one patent family members in nineteen countries.

The generic ingredient in PATADAY ONCE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-four 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:	31
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	7
Patent Applications:	1,138
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			Y
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes			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
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004

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
Denmark	1399127
Japan	2012107046	OLOPATADINE FORMULATION FOR TOPICAL ADMINISTRATION
Luxembourg	90969
Mexico	9203155	DERIVADO [B,E] OXEPINA COMO AGENTE ANTIALERGICO.
Netherlands	300101
Poland	205565
Taiwan	201249437	High concentration olopatadine ophthalmic composition

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
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
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
0799044	CA 2002 00029	Denmark
0799044	SPC/GB02/041	United Kingdom		SPC/GB02/041: 20021018
0799044	SPC029/2002	Ireland		SPC029/2002: 20040930, EXPIRES: 20170516

Market Dynamics and Financial Trajectory for Pataday Once Daily Relief

Introduction to Pataday Once Daily Relief

Pataday Once Daily Relief, formulated with olopatadine, is a significant player in the eye care market, particularly for treating allergic conjunctivitis. This product has transitioned from a prescription-only medication to an over-the-counter (OTC) offering, marking a pivotal shift in its market dynamics.

Market Size and Growth

Global Olopatadine Ophthalmic Market

The global olopatadine ophthalmic market, which includes Pataday Once Daily Relief, was estimated to be USD 1636.2 million in 2024. This market is projected to grow at a compound annual growth rate (CAGR) of 11% from 2024 to 2031[1].

Regional Market Breakdown

• North America: This region holds the largest share of the global market, with a market size of USD 654.48 million in 2024 and a CAGR of 9.2% from 2024 to 2031.
• Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 490.86 million in 2024 and a CAGR of 9.5% from 2024 to 2031.
• Asia Pacific: This region is the fastest-growing, with a market size of USD 376.33 million in 2024 and a CAGR of 13% from 2024 to 2031.
• South America and Middle East & Africa: These regions also show significant growth, with CAGRs of 10.4% and 10.7%, respectively[1].

Transition to Over-the-Counter (OTC) Status

FDA Approval and Market Impact

The FDA approval for the OTC switch of Pataday Once Daily Relief Extra Strength in July 2020 marked a significant milestone. This transition allows patients to access the medication without a prescription, which is expected to boost sales and market penetration[3].

Sales Performance Post-OTC Switch

Since the OTC switch, the Pataday brand has seen substantial sales. For instance, Dr. Reddy's, which launched store-brand equivalents of Pataday, reported U.S. sales of approximately $31 million since the launch in March 2020[4].

Product Portfolio and Variations

Pataday Product Line

The Pataday brand includes several formulations:

• Pataday Once Daily Relief (olopatadine 0.2%)
• Pataday Once Daily Relief Extra Strength (olopatadine 0.7%)
• Pataday Twice Daily Relief (olopatadine 0.1%)

Each of these products offers different strengths and dosing regimens, catering to a wide range of patient needs[3][5].

Competitive Landscape

Key Players

The olopatadine ophthalmic market is competitive, with several key players. Alcon, the global leader in eye care, is a major player with its Pataday brand. Other companies, such as Dr. Reddy's, also offer store-brand equivalents, increasing competition in the OTC segment[1][4].

Consumer Demand and Awareness

Growing Awareness of Eye Health

The Asia Pacific region, in particular, is seeing an increase in public awareness of eye health and the need to seek treatment for eye issues. This growing awareness is expected to drive the diagnosis and treatment of allergic conjunctivitis, thereby boosting the demand for olopatadine ophthalmic solutions[1].

Allergies as a Chronic Illness

Allergies, including ocular allergies, are a significant health concern. In the U.S., allergies are the sixth-leading cause of chronic illness, generating substantial OTC retail sales. This underscores the ongoing demand for effective allergy relief products like Pataday Once Daily Relief[3].

Financial Trajectory

Revenue Projections

Given the CAGR of 11% for the global olopatadine ophthalmic market, the revenue is expected to increase significantly over the forecast period. For instance, the North American market alone is projected to grow from USD 654.48 million in 2024, driven by the OTC availability and increasing consumer demand[1].

Market Share and Sales

The Pataday brand, with its strong presence and recent OTC switch, is likely to maintain a significant market share. The sales performance post-OTC switch indicates a positive financial trajectory, with continued growth anticipated as more consumers opt for OTC solutions[3][4].

Regulatory Environment

FDA Approvals and Compliance

The FDA approval for the OTC switch of Pataday Once Daily Relief Extra Strength highlights the regulatory support for such transitions. Compliance with FDA regulations and ongoing monitoring of adverse events will be crucial for maintaining market presence and consumer trust[2][3].

Key Takeaways

• Market Growth: The global olopatadine ophthalmic market is expected to grow at a CAGR of 11% from 2024 to 2031.
• Regional Dynamics: North America, Europe, and Asia Pacific are key regions driving market growth.
• OTC Transition: The FDA approval for OTC status has significantly impacted sales and market penetration.
• Product Variations: The Pataday brand offers multiple formulations to cater to different patient needs.
• Consumer Demand: Growing awareness of eye health and the prevalence of allergies drive demand for olopatadine ophthalmic solutions.
• Financial Trajectory: Revenue is projected to increase significantly, driven by market growth and OTC availability.

FAQs

What is the current market size of the global olopatadine ophthalmic market?

The global olopatadine ophthalmic market size was estimated at USD 1636.2 million in 2024[1].

What is the projected CAGR for the global olopatadine ophthalmic market from 2024 to 2031?

The global olopatadine ophthalmic market is projected to grow at a CAGR of 11% from 2024 to 2031[1].

Which region is the fastest-growing in the olopatadine ophthalmic market?

The Asia Pacific region is the fastest-growing, with a CAGR of 13% from 2024 to 2031[1].

What is the significance of the OTC switch for Pataday Once Daily Relief?

The OTC switch allows patients to access the medication without a prescription, which is expected to boost sales and market penetration[3].

Who are the key players in the olopatadine ophthalmic market?

Key players include Alcon and Dr. Reddy's, among others, offering both branded and store-brand equivalents[1][4].

How has consumer awareness impacted the market for olopatadine ophthalmic solutions?

Growing awareness of eye health, particularly in the Asia Pacific region, has driven the diagnosis and treatment of allergic conjunctivitis, boosting demand for olopatadine ophthalmic solutions[1].

Sources

1. Cognitive Market Research: Olopatadine Ophthalmic Market Report 2024 (Global Edition)
2. FDA: 21-861s000 - accessdata.fda.gov
3. Alcon: Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength
4. Biospace: Dr. Reddy's announces the launch of Over-the-Counter Olopatadine Hydrochloride Ophthalmic Solution USP 0.2 Percent and 0.1 Percent
5. Pataday: Pataday® Once Daily Relief Allergy Eye Drops