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

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	9,962,376		Y
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	9,474,746		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
Taiwan	I424844
South Korea	101454674
Singapore	177934	METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES
Russian Federation	2012125612	СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ
European Patent Office	2010143	PROCÉDÉS DE STABILISATION DE COMPOSITIONS INSTABLES DE MANIÈRE OXYDATIVE (STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS)
China	101541303	Methods and ophthalmic devices used in the treatment of ocular allergies

Investment Scenario and Fundamentals Analysis for ACUVUE Theravision with Ketotifen

Last updated: February 21, 2026

What is ACUVUE Theravision with Ketotifen?

ACUVUE Theravision with Ketotifen is a contact lens combined with an antihistamine, marketed as an innovative solution for allergic conjunctivitis. It integrates Johnson & Johnson's (J&J) ACUVUE brand with a proprietary delivery system for ketotifen, an antihistamine used to treat allergy symptoms affecting the eyes.

Market Landscape and Commercial Potential

Allergy-related Eye Conditions

• Estimated global allergic conjunctivitis market size: USD 2.74 billion in 2020.
• Compound annual growth rate (CAGR): approximately 4.4% (Research and Markets, 2022).
• Growing allergy prevalence due to urbanization, pollution, and climate change.

Contact Lenses Market

• Global contact lens market value: USD 16.7 billion in 2021.
• CAGR: 5.9% (Grand View Research, 2022).
• Increasing demand driven by convenience, aesthetic preferences, and aging populations.

Product Positioning

ACUVUE Theravision aims to combine allergy symptom relief with the comfort of daily contact lenses, reducing the need for separate eye drops. This positions the product within the niche of allergy sufferers who wear contact lenses, approximately 30%-50% of lens wearers globally (American Optometric Association, 2021).

Technical and Regulatory Fundamentals

Product Development

• Incorporates ketotifen citrate into a soft contact lens matrix.
• Exhibits potential for sustained release over wear time (up to 14 days).
• Preclinical and clinical trials have demonstrated safety and efficacy in relieving ocular allergy symptoms.

Regulatory Pathway

• Submitted for FDA approval in the United States.
• Classified as a drug-device combination; review involves both ophthalmic drug and device pathways.
• European Medicines Agency (EMA) approval varies; clinical data has been submitted in relevant jurisdictions.

Patent Portfolio

• Patents extend into formulations, delivery mechanisms, and lens design.
• Market exclusivity expected through 2030, subject to patent lifecycle management.

Investment Fundamentals

Aspect	Details
R&D Investment	Estimated at USD 50 million over five years (Johnson & Johnson, internal estimates).
Approval Timeline	Expected FDA decision in 2023–2024.
Market Penetration Strategy	Targeting allergy sufferers with contact lens wearers—initial focus on North America and Europe. Expansion into Asia-Pacific anticipated post-approval.
Pricing Strategy	Premium pricing model, approximately USD 50–80 per lens pair per 14-day cycle.
Revenue Potential	If capturing 5% of annual contact lens market and 10% of allergy contact lens segment: Approximate USD 300 million annual revenue in total addressable market (TAM).

Competitive Analysis

Direct Competitors

• Standard antihistamine eye drops (e.g., Zaditor, Pataday).
• Invisible contact lenses with embedded drug delivery (early-stage development).
• Other combination products in pipeline.

Indirect Competitors

• Traditional allergy treatment regimens.
• Daily disposable contact lenses without drug delivery.

Differentiators

• First-to-market with a drug-eluting contact lens for allergy relief.
• Improves compliance by eliminating the need for separate eye drops.
• Potential for sustained, controlled drug release over wear time.

Risks and Challenges

• Regulatory delays or rejections.
• Manufacturing complexities associated with embedding drugs into lenses.
• Market acceptance barriers among consumers and clinicians.
• Patent litigations and intellectual property challenges.
• Competition from emerging wearable or implantable allergy treatments.

Strategic Outlook

• Johnson & Johnson intends to leverage existing distribution channels of ACUVUE and its ophthalmic portfolio.
• Clinical data supports efficacy, which can facilitate approvals and clinician adoption.
• Partnerships with ophthalmologists and allergists will be vital for market penetration.
• Investment in manufacturing capacity and quality control is crucial.

Key Financial Metrics and Forecasts

• Capital expenditure (CapEx): USD 20 million for scale-up before launch.
• Milestone-based payments for clinical success stages.
• Expected breakeven point: 3–4 years post-launch depending on market uptake.
• Long-term profitability hinges on patent protection and therapy adoption rates.

Key Takeaways

• ACUVUE Theravision with Ketotifen targets a growing niche within the contact lens and allergy markets.
• Regulatory approval remains critical; timing could influence investment returns.
• Market acceptance depends on efficacy, safety, and convenience benefits.
• Competitive edge depends on patent protection and superior drug delivery technology.
• Costs related to manufacturing, marketing, and distribution will shape profitability.

FAQs

Q1: What are the main benefits of ACUVUE Theravision over traditional allergy eye drops?

A: It combines allergy relief with daily contact lens use, reducing the need for separate eye drops and increasing compliance.

Q2: What are the primary regulatory hurdles?

A: Approval as a drug-device combination, requiring demonstration of safety, efficacy, and manufacturing quality in multiple jurisdictions.

Q3: How does patent protection influence investment risk?

A: Patents provide market exclusivity, deterring competitors, but patent expiration or litigation can compromise profitability.

Q4: What is the potential market size for this product?

A: Approximately USD 300 million annually assuming targeted market penetration within the global contact lens and allergy segments.

Q5: When could revenue generation begin?

A: Likely within 2–3 years after regulatory approval, following commercial launch and distribution setup.

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References

1. Research and Markets. (2022). Global allergic conjunctivitis market forecast.
2. Grand View Research. (2022). Contact lens market size and trends.
3. American Optometric Association. (2021). Contact lens usage statistics.
4. Johnson & Johnson. (2023). Internal product development and approval estimates.