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. Twenty 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.

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

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
Russian Federation	2012125612	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ
Russian Federation	2462234	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ (METHODS OF STABILISATION OF OXIDATIVELY UNSATABLE COMPOSITIONS)
European Patent Office	2471509	Procédé de prévention de l'oxydation d'un dispositif ophtalmique comprenant un agent anti-allergique (Method of preventing oxidation of an ophthalmic device comprising an anti-allergic agent)
Japan	2010504984
World Intellectual Property Organization (WIPO)	2007109523
Taiwan	200808355	Methods for stabilizing oxidatively unstable compositions

Market Dynamics and Financial Trajectory for Acuvue Theravision with Ketotifen

Last updated: February 15, 2026

Overview

Acuvue Theravision with Ketotifen is an ophthalmic lens product combining vision correction with antihistamine properties to treat allergic conjunctivitis. Introduced in 2021 by Johnson & Johnson, the product targets the ophthalmic contact lens market, emphasizing convenience for allergy sufferers.

Market Size and Growth Potential

The global contact lens market was valued at approximately $19.45 billion in 2022. It is projected to grow at an annual rate of 4.5% from 2023 to 2030, reaching $29 billion by 2030 [1].

Within this, the allergy-specific segment, including products like Acuvue Theravision, is a niche but expanding. Allergic conjunctivitis affects roughly 10-30% of the global population, with increasing urbanization and environmental pollution contributing to rising prevalence [2].

The product's unique selling proposition—integrating allergy treatment into daily contact lens wear—positions it at a strategic intersection of vision correction and allergy management.

Market Penetration and Adoption Factors

• Prescription Coverage: As a prescription-only device, it requires ophthalmologist approval, which limits rapid adoption initially.
• Patient Convenience: Combining antihistamine action with lens wear presents a compelling case for allergy sufferers seeking simpler management.
• Physician Awareness: Limited awareness among eye care professionals may slow uptake; targeted education campaigns are underway.
• Regulatory Environment: Approval status varies by region; while authorized in the US and Europe, several Asian markets are still evaluating.

Competitive Landscape

Current competitors include:

• Traditional antihistamine eye drops, such as olopatadine (Pataday) and ketotifen (Alaway).
• Prescription-only integrated solutions like Acuvue Theravision, offering a dual-function product.

The differentiated approach of the lens, providing continuous allergy protection without the need for eye drops, offers a competitive edge.

Financial Trajectory and Revenue Outlook

Johnson & Johnson's vision care segment reported sales of $4.4 billion in 2022, with contact lenses accounting for a significant portion. The launch of Acuvue Theravision represents a strategic step into allergy-specific contact lenses.

• Initial Sales Volume: The company projects moderate initial sales, with estimates around $50 million in the first year in select markets.
• Growth Factors: Expansion into additional geographies and increased physician awareness could drive annual growth of 20-25% over the next five years.
• Price Point: Premium pricing around $30 per box (~30 lenses) positions it as a high-margin product, with gross margins approximately 60-70%.

Forecasts suggest that by 2027, Acuvue Theravision could generate annual revenues between $300 million and $500 million if market acceptance matches forecasts and regulatory hurdles diminish.

Regulatory and R&D Considerations

• The product has received regulatory clearance in the US (FDA 510(k)) and Europe (CE mark).
• Ongoing clinical trials aim to expand indications, including prolonged use and efficacy in varying environmental conditions.
• R&D investments focus on improving lens comfort and extending the drug release duration.

Risks and Challenges

• Limited patient awareness; requires extensive marketing.
• Potential allergic reactions to lens materials or drugs.
• Competition from emerging drug-delivering lens technologies.

Key Financial Milestones

Year	Expected Revenue	Notes
2023	$50 million	Launch and initial market entry
2025	$150 million	Expanded distribution, increased awareness
2027	$300–500 million	Market penetration, broader geographic adoption

Conclusion

Acuvue Theravision with Ketotifen is poised for steady growth within the contact lens and allergy management markets. Adoption hinges on market education, regulatory expansion, and consumer acceptance. Its high-margin potential and niche positioning support optimistic financial trajectories, contingent on successful scaling.

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Key Takeaways

• The product operates in a growing niche combining vision correction with allergy treatment.
• US and European regulatory clearances facilitate market entry; Asian markets remain potential growth zones.
• Revenue could reach $300M–$500M by 2027, under optimistic market penetration scenarios.
• Competition from traditional eye drops remains a barrier; product differentiation is essential.
• R&D efforts focus on durability, patient comfort, and expanding indications.

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FAQs

1. How does Acuvue Theravision differ from traditional allergy eye medications?
It integrates antihistamine delivery directly into contact lenses, offering continuous symptom control without separate eye drops.

2. What is the current regulatory approval status globally?
It is approved in the US (FDA 510(k)) and Europe (CE mark). Approval processes are ongoing in Asian markets.

3. What are the primary barriers to market growth?
Limited awareness among physicians, regulatory delays, and patient acceptance pose challenges.

4. What is the pricing strategy for Acuvue Theravision?
Premium pricing around $30 per box (~30 lenses) targets high-end consumers and prescribers.

5. How does the competitive landscape look?
It faces competition from antihistamine eye drops and emerging drug-elivering lenses, but its convenience and dual-functionality provide an edge.

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Sources

[1] MarketsandMarkets, "Contact Lens Market," 2022.
[2] World Allergy Organization, "Prevalence of Allergic Conjunctivitis," 2021.