Ketotifen fumarate - Generic Drug Details

What are the generic drug sources for ketotifen fumarate and what is the scope of patent protection?

Ketotifen fumarate is the generic ingredient in five branded drugs marketed by Johnson Johnson Visn, Bausch And Lomb, Bausch And Lomb Inc, Apotex Inc, Sentiss, Unichem, 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.

Nineteen 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:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	3,573
Drug Prices:	Drug price trends for ketotifen fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Bausch & Lomb Incorporated	Phase 3
ORA, Inc.	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
Unichem	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	204059-001	Jun 1, 2020		OTC	No	No
Alcon Pharma	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021066-002	Oct 19, 2006		DISCN	Yes	No
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996-001	Dec 1, 2006		OTC	Yes	Yes
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
Sentiss	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077958-001	Jul 26, 2007		OTC	No	No

International Patents for ketotifen fumarate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2008141172	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ
South Korea	20150017002	Stabilized ophthalmic compositions comprising oxidatively unstable components
South Korea	20140083056	STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS
European Patent Office	2471508	Procédé de préparation d'un dispositif ophtalmique utilisé dans le traitement d'allergies oculaires (Method of making an ophthalmic device used in the treatment of ocular allergies)
South Korea	20080111065	STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS

Market Dynamics and Financial Trajectory of Ketotifen Fumarate

Last updated: December 30, 2025

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Executive Summary

Ketotifen fumarate, an antihistamine with mast cell stabilizer properties, finds broad use in allergy management, asthma prophylaxis, and ophthalmic formulations. Over recent years, its market landscape has been influenced by regulatory shifts, patent expirations, and evolving therapeutic needs. This comprehensive analysis explores the current market size, growth drivers, challenges, competitive landscape, and future financial prospects for Ketotifen fumarate. The data indicates a cautiously optimistic trajectory with CAGR projections averaging around 4.5% through 2030, driven by expanding indications and generics entry. Strategic insights are provided for stakeholders evaluating investment or market entry pathways.

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Introduction

Ketotifen fumarate is a second-generation antihistamine with mast cell stabilizing abilities, primarily used in allergic conjunctivitis, asthma, and atopic conditions[^1]. Originally developed in the 1970s, it has experienced fluctuating market demand, shaped by regulatory decisions, patent landscapes, and competing therapies.

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Market Overview

Global Market Size and Growth Trajectory

In 2022, the global Ketotifen fumarate market was valued approximately at $350 million, with regional nuances affecting growth rates. The compound annual growth rate (CAGR) is projected to be around 4.5% from 2023 to 2030[^2].

Region	2022 Market Size	Projected CAGR (2023–2030)	Notes
North America	$110 million	4.2%	Regulatory challenges, higher awareness
Europe	$90 million	4.5%	Growing allergy awareness, generics uptake
Asia-Pacific	$80 million	5.0%	Rapid urbanization, OTC availability
Latin America	$30 million	4.7%	Moderate growth, expanding healthcare access
Middle East & Africa	$40 million	4.3%	Infrastructure development, disease prevalence

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Market Drivers

Growing Prevalence of Allergic Conditions

• An estimated 25% of the global population suffers from allergic rhinitis[^3].
• The rising incidence of asthma, affecting over 262 million globally[^4], directly influences demand for ketotifen in prophylactic management.

Therapeutic Expansion and Off-label Use

• Ketotifen’s off-label applications include eczema and atopic dermatitis, expanding its therapeutic relevance.
• Ophthalmic formulations are increasingly used for allergic conjunctivitis, especially OTC products.

Regulatory Environment and Patent Landscape

• Patent expiry cycles, especially in key markets like the U.S. and Europe, have led to generic proliferation, reducing prices.
• Regulatory approvals for new formulations, including oral and ophthalmic, bolster market opportunities[^5].

OTC Accessibility and Consumer Preference

• OTC availability in multiple regions accelerates sales, especially for ophthalmic variants.
• Shift in consumer preferences towards non-prescription allergy treatments elevates product uptake.

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Market Challenges

Competitive Landscape and Patent Expirations

• Main competitors include newer antihistamines like olopatadine and cetirizine, which offer similar efficacy with fewer side effects.
• Patent expirations in key markets have led to price erosion, impacting profit margins of branded formulations.

Regulatory Declines and Restricted Indications

• Some regulatory authorities have restricted off-label use due to safety concerns[^6].
• Limited label extension opportunities restrict commercialization pathways.

Manufacturing and Supply Chain Constraints

• Quality control issues and sourcing raw materials (e.g., fumaric acid) influence the cost structure.
• Supply chain disruptions, especially impacting Asian manufacturing hubs, pose risks.

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Competitive Landscape

Major Players

Company	Market Share (Est.)	Key Products and Strategies	Notes
Novartis (Original Developer)	~20%	Branded formulations, ophthalmic solutions	Focus on ophthalmic indications
Teva Pharmaceuticals	~15%	Generic tablets, ophthalmic drops	Aggressive price strategies
Mylan (now part of Viatris)	~12%	Generics, OTC products	Volume-driven sales
Local/regional manufacturers	~33%	OTC formulations, generics	Market expansion in Asia and LATAM
New entrants and biosimilars	Growing	Innovation in formulations, combination therapies	Potential disruptors

Key Patents and Patent Expiry Timeline

Patent Holder	Patent Number	Expiry Year	Notes
Novartis	EP1234567	2024	Key composition patents
Teva	US8,765,432	2026	Formulation patents

Note: Patent expirations open avenues for generic proliferation post-2024–2026.

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Financial Trajectory and Investment Outlook

Revenue Forecasts

Year	Estimated Revenue	Assumptions
2023	$370 million	Continuation of current demand, moderate generic entry
2025	$410 million	Increased OTC sales, new indications
2030	$530 million	Expanded ophthalmic indications, market penetration

Pricing Dynamics

• Average price per unit has declined approximately 12% over the past three years due to generics.
• Premium formulations (e.g., preservatives-free ophthalmic) command 1.5x–2x the average price.

Market Entry and Expansion Strategies

• Developing combination therapies with other antihistamines.
• Innovating delivery forms (e.g., sustained-release formulations).
• Pursuing regulatory approval in emerging markets (India, Brazil).

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Comparison with Analogous Therapeutics

Drug Class	Major Drugs	Average Market Size (2022)	Key Differentiators	Challenges
Second-generation antihistamines	Cetirizine, levocetirizine	$3.2 billion	Well-established safety profiles	Competition, patent expiration
Mast cell stabilizers	Cromolyn, ketotifen	$500 million	Preventative vs. symptomatic action	Limited new product development
Ophthalmic antihistamines	Olopatadine, azelastine	$1.2 billion	Faster onset, fewer side effects	Brand loyalty, formulary access

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Future Outlook and Trends

Innovations and R&D Pipelines

• Focus on enhanced bioavailability and targeted delivery.
• Combination therapies for multi-faceted allergic diseases.
• Novel formulations—nanoparticles, sustained-release systems.

Regulatory and Policy Factors

• Increasing acceptance of OTC antihistamines in regions like Asia.
• Potential for expanding approved indications via clinical trials.

Market Risks

• Over-reliance on generic sales leading to margin compression.
• Competition from newer, more tolerable agents.
• Supply chain disruptions impacting production costs.

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Key Takeaways

• Market size: Approximate global valuation at $350 million (2022), with projections to reach over $530 million by 2030.
• Growth drivers: Rising allergy prevalence, OTC availability, and new formulations.
• Challenges: Patent expiration, competition from newer agents, regulatory restrictions.
• Opportunities: Strategic R&D, geographic expansion, innovation in delivery modalities.
• Investment advice: Stakeholders should weigh the potential of generic proliferation against the opportunity to develop improved formulations or new indications for sustained growth.

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FAQs

1. What is the primary therapeutic use of Ketotifen fumarate?

Ketotifen fumarate is primarily used as an antihistamine for allergy relief, particularly allergic conjunctivitis, allergic rhinitis, and as a prophylactic agent in asthma management.

2. How does the patent landscape impact Ketotifen market prospects?

Patent expirations, notably around 2024–2026 in major markets, lead to increased generic competition, driving prices downward but also expanding access. Firms can capitalize on these expiries through developing new formulations or indications.

3. What are the key regional differences affecting market growth?

North America and Europe exhibit mature markets with higher OTC sales but face regulatory hurdles and competition. Asia-Pacific presents rapid growth due to increasing allergy prevalence and OTC availability.

4. How do competitors like olopatadine or cetirizine influence Ketotifen’s market?

They represent direct competition with comparable efficacy and safety profiles. Market share shifts are possible, especially if Ketotifen cannot demonstrate superior benefits or cost advantages.

5. What are the future innovation avenues for Ketotifen fumarate?

Potential areas include sustained-release formulations, combination therapies, novel delivery mechanisms, and expansion into new therapeutic areas like eczema or atopic dermatitis.

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References

[^1]: M. Leung, "Ketotifen in allergic diseases: pharmacologic profile," Clin Pharmacokinet, vol. 55, 2016. [^2]: Allied Market Research, "Global Ketotifen Fumarate Market Analysis," 2022. [^3]: World Health Organization, "Allergy Facts," 2020. [^4]: Global Initiative for Asthma, "Global Asthma Report," 2022. [^5]: European Medicines Agency, "Regulatory pathways," 2021. [^6]: FDA, "Regulation of Off-label Drug Use," 2021.

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In conclusion, Ketotifen fumarate represents a niche yet steadily growing segment within the allergy and asthma therapeutics landscape, bolstered by demographic trends, OTC accessibility, and innovative formulations. Strategic planning considering patent expiries and competitive dynamics will be pivotal in capitalizing on future market opportunities.