ACUVUE THERAVISION WITH KETOTIFEN Drug Patent Profile

When do Acuvue Theravision With Ketotifen patents expire, and when can generic versions of Acuvue Theravision With Ketotifen launch?

Acuvue Theravision With Ketotifen is a drug marketed by Johnson Johnson Visn and is included in one NDA. There are two patents protecting this drug.

This drug has forty-four patent family members in fifteen countries.

The generic ingredient in ACUVUE THERAVISION WITH KETOTIFEN is ketotifen fumarate. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acuvue Theravision With Ketotifen

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

Summary for ACUVUE THERAVISION WITH KETOTIFEN

International Patents:	44
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACUVUE THERAVISION WITH KETOTIFEN
What excipients (inactive ingredients) are in ACUVUE THERAVISION WITH KETOTIFEN?	ACUVUE THERAVISION WITH KETOTIFEN excipients list
DailyMed Link:	ACUVUE THERAVISION WITH KETOTIFEN at DailyMed

US Patents and Regulatory Information for ACUVUE THERAVISION WITH KETOTIFEN

ACUVUE THERAVISION WITH KETOTIFEN is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No			Y
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No			Y
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No

International Patents for ACUVUE THERAVISION WITH KETOTIFEN

See the table below for patents covering ACUVUE THERAVISION WITH KETOTIFEN around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5758074
Russian Federation	2462234	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ (METHODS OF STABILISATION OF OXIDATIVELY UNSATABLE COMPOSITIONS)
Spain	2623532
Taiwan	200815005	Methods and ophthalmic devices used in the treatment of ocular allergies
China	104614873	METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES
Australia	2007227091	Stabilized ophthalmic compositions comprising oxidatively unstable components
Argentina	059928	METODOS Y DISPOSITIVOS OFTALMICOS USADOS EN EL TRATAMIENTO DE ALERGIAS OCULARES

Market Dynamics and Financial Trajectory for ACUVUE THERAVISION WITH KETOTIFEN

Last updated: August 5, 2025

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Introduction

The convergence of ophthalmic pharmaceutical innovations and contact lens technology has fostered new therapeutic options for patients with allergic conjunctivitis. ACUVUE THERAVISION WITH KETOTIFEN exemplifies this synergy, combining antihistaminic activity within a contact lens platform. This product aims to address unmet clinical needs by providing sustained release of ketotifen, a well-established antihistamine, directly to the ocular surface. The following analysis explores the market dynamics influencing this product’s commercial trajectory and delineates the financial prospects based on current industry trends, competitive landscape, and regulatory considerations.

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Market Landscape and Unmet Needs

Allergic conjunctivitis affects approximately 15-20% of the global population, with seasonal allergic conjunctivitis (SAC) being the most prevalent form. The condition severely impacts quality of life, prompting widespread demand for effective management. Traditional treatment involves antihistamine eye drops, mast cell stabilizers, and combination therapies, which often suffer from compliance issues due to frequent dosing and temporary relief.

The advent of drug-eluting contact lenses presents an innovative delivery modality, promising sustained drug release, improved adherence, and targeted therapy. ACUVUE THERAVISION integrates ketotifen into a contact lens, enabling continuous medication delivery over extended periods—generally spanning days to weeks—which aligns with patient preferences for non-invasive, convenient treatments. This aligns with broader industry trends toward personalized and sustained ophthalmic therapies, especially as contact lens wear remains popular globally.

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Key Market Drivers

• Growing Prevalence of Allergic Conjunctivitis: As urbanization and pollution escalate, allergic conjunctivitis rates are rising. The increasing patient burden creates a sizable market opportunity for sustained-release therapies.

• Patient Compliance and Convenience: Traditional eye drops' frequent administration often undermines adherence. Therapeutic contact lenses can improve compliance, particularly among children and elderly populations.

• Technological Advancements in Drug Delivery: Innovations in ophthalmic drug-eluting lenses increase feasibility and acceptance, encouraging manufacturers to explore similar products.

• Emerging Regulatory Support: Increasing acceptance of sustained-release ocular devices by regulatory agencies (e.g., FDA, EMA) facilitates market entry, although approval processes remain rigorous.

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Market Challenges and Barriers

• Regulatory Approvals and Clinical Validation: Demonstrating safety, efficacy, and bioequivalence for combination devices like ACUVUE THERAVISION requires extensive clinical trials, delaying commercialization and elevating costs.

• Manufacturing Complexity: Integrating drugs into contact lens matrices introduces manufacturing challenges, impacting scalability and cost competitiveness.

• Market Penetration and Consumer Acceptance: Healthcare providers must be educated on new delivery formats; patient acceptance hinges on comfort, safety, and perceived efficacy.

• Intellectual Property and Competitive Landscape: While ketotifen-based methods are well-established, patent exclusivity for drug-eluting contact lenses is limited, inviting competition.

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Financial Outlook and Revenue Projections

Revenue Drivers

• Market Penetration and Adoption: As awareness grows, initial adoption is projected among moderate-to-high allergy burden demographics—primarily in North America and Europe.

• Pricing Strategy: Premium pricing is anticipated due to novel delivery system, potentially ranging from $50–$100 per lens or treatment cycle.

• Volume Growth: With increasing manufacturing scalability and consumer acceptance, annual sales volumes could expand significantly within 3–5 years post-launch.

Cost Structure and Investment

• Research & Development (R&D): R&D investments, including clinical trials and manufacturing process development, are substantial, often exceeding hundreds of millions of dollars for novel ophthalmic devices.

• Regulatory Approvals: Expenses for regulatory filings, patient safety assessments, and post-market surveillance are significant but necessary hurdles.

• Manufacturing & Distribution: As production scales, per-unit costs decrease; however, initial capital expenditure remains high due to specialized equipment and quality controls.

Forecasting Financial Trajectory

Based on comparable ophthalmic drug-device combinations and industry reports, the following is an approximation:

• Short-term (1–2 years): Post-approval, initial sales are modest—$10–$50 million globally—due to limited clinician familiarity and regulatory ramp-up.

• Mid-term (3–5 years): Market expansion, increased physician endorsement, and brand recognition could propel revenues to $200–$500 million annually.

• Long-term (beyond 5 years): With further technological evolution and broader indications, revenues potentially exceed $1 billion annually, capturing a significant market share in allergy therapeutics.

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Competitive Landscape

While ACUVUE is a prominent player, several competitors are exploring similar modalities, including:

• Alcon and Bausch + Lomb: Developing drug-eluting lenses for various ocular conditions.

• Startups and biotech firms: Innovating in nanoparticle-based drug delivery embedded in contact lenses.

• Traditional eye drops manufacturers: Potentially entering the space through partnerships or in-house innovation.

Market entries depend heavily on the efficacy, safety profile, cost competitiveness, and regulatory navigation by these players.

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Regulatory and Market Entry Considerations

Successful commercialization hinges on comprehensive clinical data demonstrating superior efficacy, safety, and patient acceptability. Early engagement with regulatory agencies is vital to streamline approval pathways for combination devices. Moreover, payer acceptance and reimbursement strategies will influence market penetration, emphasizing the importance of demonstrating long-term cost savings and improved health outcomes.

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Conclusion

ACUVUE THERAVISION WITH KETOTIFEN is positioned at the intersection of ophthalmic drug delivery innovation and allergy management, entering a rapidly evolving market. The product's success depends on overcoming manufacturing, regulatory, and acceptance barriers. Financially, the outlook is promising, with significant growth potential driven by unmet needs, technological advantages, and rising allergy prevalence. Long-term profitability hinges on strategic investments, clinical validation, and effective stakeholder engagement within the ophthalmic and allergology sectors.

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Key Takeaways

• The global allergy burden and patient preferences for convenience favor sustained drug delivery via contact lenses.
• Technological and regulatory advancements are enabling new ophthalmic therapeutic modalities, creating lucrative opportunities.
• Significant upfront R&D and manufacturing costs are offset by substantial growth potential within 3–5 years.
• Competitive pressure necessitates robust clinical data and distinct value propositions.
• Payer acceptance, clinical adoption, and patient compliance are critical to maximizing financial trajectory.

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FAQs

1. What makes ACUVUE THERAVISION with Ketotifen unique compared to traditional allergy treatments?
It offers sustained, controlled drug delivery through a contact lens, reducing dosing frequency and improving adherence over conventional eye drops.

2. What are the main regulatory hurdles for bringing drug-eluting contact lenses to market?
Demonstrating safety and efficacy through extensive clinical trials, navigating complex approval pathways for combination devices, and establishing manufacturing standards are key challenges.

3. How does the contact lens delivery system impact patient compliance?
By providing continuous medication over days or weeks, it minimizes frequent application, thereby increasing adherence—particularly beneficial for pediatric and elderly populations.

4. What is the expected global market for allergy-related ophthalmic therapies in the next decade?
Analytical estimates project the market to exceed $3 billion annually by 2030, with sustained growth driven by technological innovations like drug-eluting contact lenses.

5. Which regions are most promising for the commercial success of ACUVUE THERAVISION?
North America and Europe are primary markets owing to advanced healthcare infrastructure, regulatory pathways, and high prevalence of allergic conjunctivitis; Asia-Pacific also offers significant growth potential.

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Sources

[1] Bloom, L. (2022). Trends in Ophthalmic Drug Delivery Technologies. Ophthalmic Pharma Reports, 8(3), 45-57.
[2] Global Allergic Conjunctivitis Market Forecast 2023-2030. MarketWatch.
[3] U.S. Food and Drug Administration. (2021). Guidance for Drug-Device Combination Products.
[4] Smith, R., & Patel, M. (2021). Contact Lenses as Drug Delivery Devices: Innovation & Challenges. Journal of Ophthalmic Innovation, 12(4), 234-245.