ZADITOR Drug Patent Profile

When do Zaditor patents expire, and what generic alternatives are available?

Zaditor is a drug marketed by Alcon Pharma and Alcon Pharms Ltd and is included in two NDAs.

The generic ingredient in ZADITOR is ketotifen fumarate. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zaditor

A generic version of ZADITOR was approved as ketotifen fumarate by APOTEX INC on May 9^th, 2006.

Summary for ZADITOR

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	4
Patent Applications:	3,864
Drug Prices:	Drug price information for ZADITOR
DailyMed Link:	ZADITOR at DailyMed

See drug prices for ZADITOR

Recent Clinical Trials for ZADITOR

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

Sponsor	Phase
National University, Singapore	Phase 2
Sen-Jam Pharmaceutical	Phase 2
Bausch & Lomb Incorporated	Phase 3

See all ZADITOR clinical trials

Pharmacology for ZADITOR

Drug Class	Histamine-1 Receptor Inhibitor
Mechanism of Action	Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for ZADITOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZADITOR	Ophthalmic Solution	ketotifen fumarate	0.025%	021066	1	2004-12-23

US Patents and Regulatory Information for ZADITOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharma	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021066-002	Oct 19, 2006		DISCN	Yes	No
Alcon Pharms Ltd	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077200-001	Sep 2, 2008		OTC	No	Yes

International Patents for ZADITOR

See the table below for patents covering ZADITOR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	146973
Hungary	230738	Ophthalmic composition comprising ketotifen
Brazil	PI0017528	uso de uma composição contendo sal de cetotifeno
New Zealand	516108	Ophthalmic composition containing ketotifen and a non-ionic tonicity agent
European Patent Office	1047406	COMPOSITIONS PHARMACEUTIQUES AUTOCLAVABLES, CONTENANT UN CHELATEUR (AUTOCLAVABLE PHARMACEUTICAL COMPOSITIONS CONTAINING A CHELATING AGENT)
World Intellectual Property Organization (WIPO)	0107049

ZADITOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZADITOR

Introduction to ZADITOR

ZADITOR, also known as ketotifen fumarate ophthalmic solution, is a medication used for the temporary relief of ocular itching associated with allergic conjunctivitis. It is a key product in the portfolios of major pharmaceutical companies, particularly Alcon.

Market Size and Growth

The global allergic conjunctivitis market, within which ZADITOR operates, has seen significant growth and is expected to continue this trend. As of 2023, the global allergic conjunctivitis market size was USD 3.04 billion and is projected to grow to USD 4.96 billion by 2032, with a CAGR of 5.6% from 2024 to 2032[1].

Impact of COVID-19

The COVID-19 pandemic had a temporary negative impact on the market, including a decline in visits to ophthalmologists and a subsequent decline in sales for companies like Alcon. However, the market rebounded in 2021, and by 2022 and 2023, it had returned to pre-pandemic growth rates. This recovery was driven by the resumption of delayed treatments and the launch of new products[1].

Competitive Landscape

The allergic conjunctivitis market is dominated by a few key players, including Allergan (AbbVie Inc.), Bausch & Lomb, and Alcon. These companies have strong product portfolios that include widely adopted medications like Lastacaft, Bepreve, and SYSTANE ZADITOR. Alcon, in particular, has a significant presence in the market with ZADITOR being one of its flagship products[1].

Product Performance and Innovations

ZADITOR has delivered strong financial performance for Alcon. The product is part of Alcon's Vision Care segment, which saw double-digit growth in 2021, driven by the demand for eye drops, including the Systane and Pataday families of products. ZADITOR's effectiveness in preventing ocular itching and redness associated with allergic conjunctivitis has been demonstrated in clinical studies, making it a preferred choice for patients[2].

Clinical Efficacy and Safety

In human conjunctival allergen challenge studies, ZADITOR was significantly more effective than placebo in preventing ocular itching and redness. The medication is safe and well-tolerated, with common adverse reactions including conjunctival hyperemia, eye irritation, and headache. These reactions are generally mild and do not result in discontinuation of the medication[3].

Market Drivers

Several factors drive the market for ZADITOR and similar medications:

• Increasing Prevalence of Ocular Allergies: The rising incidence of ocular allergies is a significant driver, as more people seek effective treatments.
• Launch of New Medications: The introduction of new products and the switch from prescription to over-the-counter (OTC) medications are key growth drivers[1].
• Focus on OTC Medications: There is an increasing focus on OTC medications, which makes products like ZADITOR more accessible to a broader audience.

Financial Performance of Alcon

Alcon's financial performance has been robust, with net sales to third parties increasing by 22% in 2021 compared to 2020. The company's Vision Care segment, which includes ZADITOR, saw strong demand for eye drops and other ophthalmic products. In 2023, Alcon's net sales to third parties increased by 8%, or 10% on a constant currency basis, driven by strong performance in international markets and across the Vision Care portfolio[2][5].

Regional Market Dynamics

The North American market is a significant segment for ZADITOR, with the region accounting for a substantial share of the global allergic conjunctivitis market. As of 2023, the North America market stood at USD 1.48 billion. The market is also growing in other regions, particularly in Asia Pacific, where increasing consumer awareness and the development of novel technologies are driving growth[1][4].

Strategic Initiatives and Partnerships

Companies like Alcon are investing heavily in research and development to strengthen their product pipelines. Alcon has expanded its contact lens manufacturing capacity and continued to invest in new product launches and sales and marketing efforts. These initiatives are crucial for maintaining market leadership and driving future growth[2].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces challenges such as supply chain disruptions and foreign exchange impacts. However, these challenges also present opportunities for innovation and operational efficiency improvements. For instance, Alcon's transformation program has optimized its cost structure and created greater organizational agility[2][5].

Key Takeaways

• The global allergic conjunctivitis market is growing, driven by increasing prevalence of ocular allergies and new product launches.
• ZADITOR is a key product in Alcon's portfolio, contributing significantly to the company's financial performance.
• The market is expected to continue growing, with a CAGR of 5.6% from 2024 to 2032.
• Regional dynamics, particularly in North America and Asia Pacific, play a crucial role in market growth.
• Strategic investments in R&D and operational efficiency are essential for maintaining market leadership.

FAQs

1. What is ZADITOR used for?

ZADITOR, or ketotifen fumarate ophthalmic solution, is used for the temporary relief of ocular itching associated with allergic conjunctivitis.

2. How has the COVID-19 pandemic affected the market for ZADITOR?

The COVID-19 pandemic had a temporary negative impact on the market due to lockdowns and delayed treatments, but the market rebounded in 2021 and has since returned to pre-pandemic growth rates.

3. Who are the key players in the allergic conjunctivitis market?

The key players include Allergan (AbbVie Inc.), Bausch & Lomb, and Alcon, with Alcon being a significant player due to its strong product portfolio.

4. What are the common adverse reactions associated with ZADITOR?

Common adverse reactions include conjunctival hyperemia, eye irritation, eye pain, and headache, which are generally mild and do not result in discontinuation of the medication.

5. What is the projected growth rate of the global allergic conjunctivitis market?

The global allergic conjunctivitis market is projected to grow at a CAGR of 5.6% from 2024 to 2032.

Cited Sources:

1. Fortune Business Insights - Allergic Conjunctivitis Market Size, Share & Growth [2032]
2. Alcon - 2021 Annual Report
3. Health Canada - Ketotifen Fumarate Ophthalmic Solution
4. Grand View Research - Ophthalmic Drugs Market Size & Share | Industry Report 2030
5. Alcon - 2023 Annual Report