KETOTIFEN FUMARATE - Generic Drug Details

What are the generic sources for ketotifen fumarate and what is the scope of freedom to operate?

Ketotifen fumarate is the generic ingredient in five branded drugs marketed by Johnson Johnson Visn, Bausch And Lomb, Bausch And Lomb Inc, Apotex Inc, Bayshore Pharms Llc, Sentiss, Alcon Pharma, and Alcon Pharms Ltd, and is included in eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketotifen fumarate has forty-four patent family members in fifteen countries.

Eighteen suppliers are listed for this compound.

Summary for KETOTIFEN FUMARATE

International Patents:	44
US Patents:	2
Tradenames:	5
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	12
Patent Applications:	1,527
Drug Prices:	Drug price trends for KETOTIFEN FUMARATE
What excipients (inactive ingredients) are in KETOTIFEN FUMARATE?	KETOTIFEN FUMARATE excipients list
DailyMed Link:	KETOTIFEN FUMARATE at DailyMed

See drug prices for KETOTIFEN FUMARATE

Recent Clinical Trials for KETOTIFEN FUMARATE

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

Sponsor	Phase
Peking University Third Hospital	Phase 4
ORA, Inc.	Phase 3
EyeMax, LLC	Phase 3

See all KETOTIFEN FUMARATE clinical trials

Pharmacology for KETOTIFEN FUMARATE

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

Medical Subject Heading (MeSH) Categories for KETOTIFEN FUMARATE

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for KETOTIFEN FUMARATE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for KETOTIFEN FUMARATE

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 KETOTIFEN FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996-001	Dec 1, 2006		OTC	Yes	Yes
Bausch And Lomb Inc	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	208158-001	Sep 24, 2020		OTC	No	No
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	9,962,376		Y

International Patents for KETOTIFEN FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	2009530314
Hong Kong	1132176	用於使氧化不穩定的組合物穩定的方法 (STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS)
Brazil	PI0709549	métodos para estabilizar composições instáveis oxidativamente

KETOTIFEN FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ketotifen Fumarate

Introduction

Ketotifen fumarate, a versatile medication used to treat various allergic conditions, has been gaining significant traction in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of ketotifen fumarate, highlighting its current status, future projections, and key factors influencing its market performance.

Market Overview

The ketotifen fumarate market is characterized by a growing demand driven by its efficacy in treating allergy and asthma symptoms. The global market size was valued at approximately USD 400 million in 2023 and is projected to reach around USD 650 million by 2032, indicating a robust growth trajectory[4].

Therapeutic Applications

Ketotifen fumarate is used in various therapeutic applications, including:

Allergic Conjunctivitis

Ketotifen eye solution is widely used to relieve itching of the eyes caused by pollen, ragweed, grass, animal hair, and dander. It is available over-the-counter (OTC) under several brand names such as Alaway, Claritin Eye, Zaditor, and Zyrtec Itchy Eye[2].

Asthma and Respiratory Disorders

Orally administered ketotifen is a prophylactic agent for managing bronchial asthma and other allergic disorders. It significantly reduces respiratory symptoms and the need for concomitant antiasthmatic drugs in patients with mild to moderate bronchial asthma[3].

Other Allergic Conditions

Ketotifen also has pronounced antihistaminic and antianaphylactic properties, making it effective in treating atopic dermatitis, seasonal or perennial rhinitis, chronic or acute urticaria, and food allergies[3].

Market Drivers

Increasing Prevalence of Allergies

The rising prevalence of allergic disorders globally is a significant driver for the ketotifen fumarate market. As more people seek effective treatments for allergies and asthma, the demand for ketotifen fumarate is expected to increase.

Patient Acceptance and Efficacy

Ketotifen fumarate has shown comparable clinical utility to established agents like sodium cromoglycate and histamine H1-antagonists. Its oral administration and moderate to marked symptom improvement in various allergic conditions enhance patient acceptance and compliance[3].

Regulatory Approvals

Ketotifen fumarate ophthalmic solution has received regulatory approvals in several regions, including the United States, where it is approved for prescription use under the brand name Zaditor[5].

Market Restraints

Side Effects and Interactions

While ketotifen fumarate is generally well-tolerated, it can cause side effects such as changes in vision, eye pain or redness, and itching that worsens or lasts more than 72 hours. Additionally, interactions with other medications and substances like alcohol and tobacco need to be considered[2].

Pediatric and Geriatric Use

The safety and efficacy of ketotifen fumarate in children younger than 3 years of age have not been established, and its use in geriatric patients requires careful monitoring due to potential interactions with other medications[2].

Financial Projections

Market Size and Growth

The global ketotifen fumarate market is expected to grow from USD 400 million in 2023 to approximately USD 650 million by 2032, representing a compound annual growth rate (CAGR) driven by increasing demand and expanding therapeutic applications[4].

Revenue Streams

Revenue from ketotifen fumarate is generated through both prescription and OTC sales. The OTC segment, particularly for eye solutions, contributes significantly to the overall revenue due to its widespread use and easy accessibility[2].

Competitive Landscape

Key Players

The market for ketotifen fumarate is competitive, with several key players including pharmaceutical companies that manufacture and distribute the medication under various brand names. Companies like Novartis and Johnson & Johnson are prominent in this space[2].

Market Share

The competitive landscape is characterized by a mix of branded and generic products. Branded products like Zaditor and Alaway hold significant market share due to their established reputation and marketing efforts[4].

Regional Analysis

Global Distribution

Ketotifen fumarate is available in various regions, including North America, Europe, Asia-Pacific, and Latin America. The demand varies by region, with North America and Europe being major markets due to higher prevalence rates of allergic disorders[4].

Emerging Markets

Emerging markets in Asia-Pacific and Latin America are expected to contribute significantly to the growth of the ketotifen fumarate market, driven by increasing healthcare spending and awareness about allergic treatments[4].

Future Outlook

Innovations and R&D

Continuous research and development are crucial for the future growth of the ketotifen fumarate market. Innovations in formulation and delivery methods could enhance patient compliance and efficacy, further expanding the market[3].

Regulatory Environment

Changes in regulatory policies and approvals can significantly impact the market. Favorable regulatory environments can facilitate the entry of new products and increase market penetration[5].

Key Takeaways

• The ketotifen fumarate market is growing rapidly due to its efficacy in treating allergic conditions.
• The global market size is projected to reach USD 650 million by 2032.
• Key drivers include increasing prevalence of allergies, patient acceptance, and regulatory approvals.
• Side effects, pediatric and geriatric use limitations, and competitive landscape are significant restraints.
• The market is expected to benefit from innovations in formulation and favorable regulatory environments.

FAQs

What is ketotifen fumarate used for?

Ketotifen fumarate is used to treat various allergic conditions, including allergic conjunctivitis, bronchial asthma, atopic dermatitis, and other allergic disorders.

Is ketotifen fumarate available over-the-counter?

Yes, ketotifen fumarate eye solution is available over-the-counter under several brand names such as Alaway, Claritin Eye, Zaditor, and Zyrtec Itchy Eye.

What are the common side effects of ketotifen fumarate?

Common side effects include changes in vision, eye pain or redness, and itching that worsens or lasts more than 72 hours.

How is the ketotifen fumarate market expected to grow?

The global ketotifen fumarate market is expected to grow from USD 400 million in 2023 to approximately USD 650 million by 2032.

What are the key drivers of the ketotifen fumarate market?

Key drivers include the increasing prevalence of allergies, patient acceptance, and regulatory approvals.

Sources

1. Market Research Intellect: Ketotifen Fumarate Market - Market Research Intellect
2. Mayo Clinic: Ketotifen (ophthalmic route) - Mayo Clinic
3. PubMed: Ketotifen. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy.
4. Dataintelo: Ketotifen Fumarate Market Research Report 2032 - Dataintelo
5. FDA: center for drug evaluation and - accessdata.fda.gov