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-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 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:	1,138
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	5,641,805*PED
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 TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892

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
Norway	970517
Spain	2179198
Spain	2038608
Canada	1337603	DERIVE DE DIBENZ[B,E] OXEPINE ET AGENT ANTIALLERGIQUE ET ANTIINFLAMMATOIRE (DIBENZ[B,E]OXEPIN DERIVATIVE AND ANTIALLERGIC AND ANTIINFLAMMATORY AGENT)

Supplementary Protection Certificates for PATADAY TWICE DAILY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0799044	SPC/GB02/041	United Kingdom		SPC/GB02/041: 20021018
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	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

PATADAY TWICE DAILY RELIEF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pataday Twice Daily Relief

Introduction to Pataday Twice Daily Relief

Pataday Twice Daily Relief, an olopatadine hydrochloride ophthalmic solution, is a dual-action medication designed to provide relief from ocular allergies. It acts as both an antihistamine and a mast cell stabilizer, offering rapid and sustained relief from itching, redness, and other symptoms associated with allergic conjunctivitis[3].

Global Market Overview

The global olopatadine ophthalmic market, which includes Pataday Twice Daily Relief, is projected to grow significantly over the next few years. As of 2024, the global market size for olopatadine ophthalmic solutions is estimated at USD 1636.2 million, with a compound annual growth rate (CAGR) of 11% from 2024 to 2031[1].

Regional Market Performance

North America

North America holds a significant share of the global olopatadine ophthalmic market, accounting for more than 40% of the global revenue. In 2024, the North American market size was estimated at USD 654.48 million, with a CAGR of 9.2% from 2024 to 2031. This region is a key market for Pataday products, including Pataday Twice Daily Relief, due to high consumer awareness and access to healthcare[1].

Europe

Europe also constitutes a substantial portion of the market, with a market size of USD 490.86 million in 2024 and a CAGR of 9.5% from 2024 to 2031. The European market is driven by similar factors as North America, including high healthcare standards and consumer demand for effective allergy treatments[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for olopatadine ophthalmic solutions, with a market size of USD 376.33 million in 2024 and a CAGR of 13% from 2024 to 2031. This growth is attributed to increasing public awareness of eye health and the relaxation of regulatory restrictions in some countries, which enhances market access for drugs like Pataday Twice Daily Relief[1].

South America and Middle East & Africa

South America and the Middle East & Africa also contribute to the global market, although to a lesser extent. South America had a market size of USD 81.81 million in 2024 with a CAGR of 10.4%, while the Middle East & Africa had a market size of USD 32.72 million in 2024 with a CAGR of 10.7% from 2024 to 2031[1].

Product Specifics and Market Impact

Dual-Action Mechanism

Pataday Twice Daily Relief stands out due to its dual-action mechanism, providing both antihistamine and mast cell stabilizer effects. This dual action offers rapid relief from ocular itching and redness, making it a preferred choice for patients suffering from allergic conjunctivitis[3].

OTC Availability

The availability of Pataday products, including Pataday Twice Daily Relief, over-the-counter (OTC) has significantly expanded their market reach. This switch from prescription to OTC has made these products more accessible to a broader consumer base, contributing to increased sales and market growth[3][4].

Financial Performance and Sales

Revenue and Growth

Since its launch in March 2020, the Pataday brand, which includes Pataday Twice Daily Relief, has generated substantial revenue. For instance, Dr. Reddy's Olopatadine hydrochloride ophthalmic solution, a store-brand equivalent of Pataday, has seen U.S. sales of approximately $31 million since its launch[4].

Competitive Landscape

The olopatadine ophthalmic market is competitive, with several players including Alcon, Dr. Reddy’s Laboratories, and others. Companies like Dr. Reddy’s have leveraged strategic collaborations to bring these products to the market, enhancing their financial performance and market presence[4].

Clinical Efficacy and Safety

Clinical Studies

Clinical studies have demonstrated the efficacy and safety of Pataday Twice Daily Relief. For example, the product has shown a significant reduction in ocular redness and itching compared to vehicle controls, with a favorable safety profile and few reports of adverse events[3].

Adverse Reactions

While generally well-tolerated, common adverse reactions associated with Pataday Twice Daily Relief include ocular pain, decreased visual acuity, ocular discomfort, and dry eye. However, these reactions are typically mild and occur in a small percentage of patients[3].

Market Drivers and Challenges

Increasing Awareness and Regulatory Changes

The growth of the olopatadine ophthalmic market is driven by increasing public awareness of eye health and the relaxation of regulatory restrictions in some regions. These factors are expected to continue driving the market forward[1].

Economic Factors

Rising disposable incomes, particularly in the Asia Pacific region, are also contributing to the market growth. However, economic fluctuations and currency impacts can pose challenges to the financial trajectory of the market[1].

Key Players and Strategic Moves

Alcon and Dr. Reddy’s Laboratories

Companies like Alcon and Dr. Reddy’s Laboratories are key players in the olopatadine ophthalmic market. These companies have invested heavily in research and development, and strategic collaborations have been crucial in their market strategies[2][4].

Future Outlook

The future outlook for Pataday Twice Daily Relief and the broader olopatadine ophthalmic market is promising. With a projected CAGR of 11% globally and significant growth in key regions, the market is expected to expand substantially over the next few years. The continued increase in public awareness of eye health, along with regulatory changes and economic growth, will likely drive this expansion[1].

Key Takeaways

• The global olopatadine ophthalmic market is projected to grow at a CAGR of 11% from 2024 to 2031.
• North America and Europe are significant markets, while the Asia Pacific region is the fastest-growing.
• Pataday Twice Daily Relief’s dual-action mechanism and OTC availability have contributed to its market success.
• Clinical studies have demonstrated the efficacy and safety of the product.
• Market growth is driven by increasing awareness of eye health and regulatory changes.

Frequently Asked Questions (FAQs)

Q: What is the global market size for olopatadine ophthalmic solutions in 2024? A: The global market size for olopatadine ophthalmic solutions in 2024 is estimated at USD 1636.2 million[1].

Q: What is the CAGR for the olopatadine ophthalmic market from 2024 to 2031? A: The CAGR for the olopatadine ophthalmic market from 2024 to 2031 is 11%[1].

Q: Which region is the fastest-growing market for olopatadine ophthalmic solutions? A: The Asia Pacific region is the fastest-growing market for olopatadine ophthalmic solutions, with a CAGR of 13% from 2024 to 2031[1].

Q: What are the common adverse reactions associated with Pataday Twice Daily Relief? A: Common adverse reactions include ocular pain, decreased visual acuity, ocular discomfort, and dry eye[3].

Q: Why is the olopatadine ophthalmic market growing in the Asia Pacific region? A: The market is growing in the Asia Pacific region due to increasing public awareness of eye health and the relaxation of regulatory restrictions, along with rising disposable incomes[1].

Cited Sources:

1. Cognitive Market Research - Olopatadine Ophthalmic Market Report 2024 (Global Edition)
2. Alcon - Q4 2022 Interim Financial Report
3. Modern Ophthalmology - Dual-Action Topical Medications for Ocular Allergies Available Over-the-Counter
4. Biospace - Dr. Reddy's announces the launch of Over-the-Counter Olopatadine Hydrochloride Ophthalmic Solution USP 0.2 percent and 0.1 percent, the store-brand equivalent of Pataday, the eye allergy drop in the U.S. market.