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. Eighteen 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	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
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
Australia	2007305205	Methods and ophthalmic devices used in the treatment of ocular allergies
Brazil	PI0709549	métodos para estabilizar composições instáveis oxidativamente
China	101420934	Methods for stabilizing oxidatively unstable compositions
European Patent Office	2471507	Dispositifs ophtalmiques utilisés dans le traitement d'allergies oculaires (Ophthalmic devices used in the treatment of ocular allergies)
Japan	2010504984
Spain	2623532
Spain	2624960

Market Dynamics and Financial Trajectory for ACUVUE Theravision with Ketotifen

Introduction

ACUVUE Theravision with Ketotifen, a groundbreaking drug-eluting contact lens developed by Johnson & Johnson Vision, has revolutionized the treatment of allergic conjunctivitis and vision correction. This innovative product has not only changed the landscape of eye health but also presents significant market and financial implications.

Market Need and Demand

Allergic conjunctivitis affects a substantial portion of the population, with approximately 20% of the general population and 40% of contact lens wearers in the U.S. suffering from ocular allergies[2][3]. This widespread prevalence creates a high demand for effective treatments, making ACUVUE Theravision with Ketotifen a highly sought-after solution.

Product Innovation

ACUVUE Theravision with Ketotifen is the world's first and only drug-eluting daily disposable contact lens with an established antihistamine, ketotifen. This innovation integrates vision correction with the prevention of ocular itch due to allergic conjunctivitis, offering a comprehensive solution for eligible contact lens wearers[1][3][4].

Clinical Efficacy

The product has demonstrated superior efficacy in clinical studies. Phase 3 studies (CR-4483 and CR-4484) showed a clinically and statistically meaningful reduction in ocular itch compared to non-medicated lenses, with relief starting as soon as 3 minutes after lens insertion and lasting up to 12 hours[1][2][5].

Regulatory Approvals

ACUVUE Theravision with Ketotifen received FDA approval in February 2022 and has also been approved in Japan and Canada following regulatory approvals in 2021. These approvals have expanded its market reach and accessibility[1][3][4].

Market Growth and Projections

The conjunctivitis treatment market, within which ACUVUE Theravision with Ketotifen operates, is expected to grow steadily. The market size is projected to increase from $4.49 billion in 2023 to $5.48 billion by 2028, with a compound annual growth rate (CAGR) of 4.0%[3].

Key Drivers of Growth

• Increased Emphasis on Preventive Healthcare: Efforts to minimize the occurrence of conjunctivitis are driving demand for preventive treatments.
• Rising Global Incidence: The growing incidence of conjunctivitis due to environmental allergens and an aging population is increasing the need for effective treatments.
• Advancements in Eye Care Infrastructure: Improved access to medical services and advancements in eye care infrastructure are enhancing the market.
• Integration of Artificial Intelligence: The use of AI in diagnosis and management is expected to further boost the market[3].

Financial Trajectory

The therapeutic contact lenses market, which includes ACUVUE Theravision with Ketotifen, is also experiencing significant growth. The global therapeutic contact lenses market was valued at $3.78 billion in 2021 and is predicted to reach $7.11 billion by 2030, growing at a CAGR of 7.28%[4].

Revenue Impact

Johnson & Johnson Vision's innovative product is expected to contribute substantially to the company's revenue. The unique positioning of ACUVUE Theravision with Ketotifen as a first-in-class treatment for allergic conjunctivitis and vision correction is likely to capture a significant market share, driving revenue growth.

Competitive Landscape

The market for conjunctivitis treatments is competitive, but ACUVUE Theravision with Ketotifen's innovative technology sets it apart. Johnson & Johnson Vision's strong brand presence and the product's clinical efficacy are key factors in its market dominance[1][3][4].

Trends and Future Outlook

Combination Therapies

There is a growing demand for combination therapies that offer comprehensive solutions, and ACUVUE Theravision with Ketotifen fits perfectly into this trend[3].

Patient Comfort and Symptom Management

The market is shifting towards enhancing patient comfort and managing symptoms effectively, areas where ACUVUE Theravision with Ketotifen excels[3].

Regulatory Shifts

Regulatory changes affecting treatment approvals and standards will continue to influence the market. The FDA approval of ACUVUE Theravision with Ketotifen sets a precedent for future innovations[3].

Key Takeaways

• Innovative Solution: ACUVUE Theravision with Ketotifen is a groundbreaking drug-eluting contact lens that combines vision correction with the prevention of ocular itch due to allergic conjunctivitis.
• Strong Market Demand: The product addresses a significant need in the market, driven by the high prevalence of allergic conjunctivitis.
• Clinical Efficacy: Demonstrated superior efficacy in clinical studies, providing quick and sustained relief.
• Regulatory Approvals: Approved by the FDA and other regulatory bodies, expanding its market reach.
• Market Growth: Expected to contribute to the growth of the conjunctivitis treatment and therapeutic contact lenses markets.
• Financial Impact: Likely to drive significant revenue for Johnson & Johnson Vision due to its unique positioning and market demand.

FAQs

What is ACUVUE Theravision with Ketotifen?

ACUVUE Theravision with Ketotifen is a daily disposable contact lens that integrates an antihistamine, ketotifen, to prevent ocular itch due to allergic conjunctivitis while providing vision correction.

Who is eligible to use ACUVUE Theravision with Ketotifen?

Eligible users include contact lens wearers with allergic conjunctivitis who do not have red eyes and have up to 1.00 D of astigmatism.

How quickly does ACUVUE Theravision with Ketotifen provide relief?

The product provides relief from ocular itch as soon as 3 minutes after lens insertion and lasts up to 12 hours.

What are the common adverse events associated with ACUVUE Theravision with Ketotifen?

Common adverse events include eye irritation, eye pain, instillation site irritation, dry eye, photophobia, and mydriasis[2].

Is ACUVUE Theravision with Ketotifen available globally?

It has been approved in the U.S., Japan, and Canada, with ongoing efforts to expand its global availability[1][3][4].

Sources

1. Johnson & Johnson Vision Named a Winner of Fast Company's 2022 World Changing Ideas Awards for ACUVUE Theravision with Ketotifen. PR Newswire.
2. Clinical Review (Acuvue) - FDA. FDA.
3. Conjunctivitis Treatment Global Market Report 2024. ResearchAndMarkets.
4. Therapeutic Contact Lenses Market Size is projected to reach USD 7.11 Billion by 2030. GlobeNewswire.
5. Acuvue Theravision with Ketotifen: Package Insert / Prescribing Info. Drugs.com.