VUITY Drug Patent Profile

When do Vuity patents expire, and what generic alternatives are available?

Vuity is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-three countries.

The generic ingredient in VUITY is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vuity

A generic version of VUITY was approved as pilocarpine hydrochloride by PADAGIS US on November 16^th, 2004.

Summary for VUITY

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Patent Applications:	4,022
Drug Prices:	Drug price information for VUITY
What excipients (inactive ingredients) are in VUITY?	VUITY excipients list
DailyMed Link:	VUITY at DailyMed

See drug prices for VUITY

Pharmacology for VUITY

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Paragraph IV (Patent) Challenges for VUITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VUITY	Ophthalmic Solution	pilocarpine hydrochloride	1.25%	214028	1	2022-12-30

US Patents and Regulatory Information for VUITY

VUITY is protected by six US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214028-001	Oct 28, 2021		RX	Yes	Yes
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214028-001	Oct 28, 2021		RX	Yes	Yes
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214028-001	Oct 28, 2021		RX	Yes	Yes
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214028-001	Oct 28, 2021		RX	Yes	Yes

International Patents for VUITY

See the table below for patents covering VUITY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3681500
Australia	2020203311
Japan	2021522256	眼の状態の治療のためのピロカルピン塩酸塩の使用
Denmark	3681500

VUITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VUITY

Introduction to VUITY

VUITY, developed by Allergan, an AbbVie company, is the first and only FDA-approved eye drop treatment for age-related presbyopia in adults. Presbyopia is a common age-related condition characterized by the decline in the eye's ability to focus on nearby objects. VUITY is a pilocarpine 1.25% ophthalmic solution, a muscarinic receptor agonist, designed to improve near vision without the need for reading glasses or other corrective measures[1][5].

Market Approval and Launch

VUITY received FDA approval on October 29, 2021, and was made available in the market in December 2021. The approval and subsequent launch marked a significant milestone in the treatment of presbyopia, offering patients a convenient and effective solution[2][5].

Public Interest and Awareness

Following its approval, VUITY saw a significant increase in public interest, particularly driven by direct-to-consumer advertising. Google Trends data indicate notable spikes in search volumes for VUITY in October 2021, December 2021, and from March to April 2022, coinciding with its approval, availability, and advertising campaigns. Key search terms included "VUITY cost," "where to buy VUITY," and "VUITY side effects," with retinal detachment being a highly searched side effect[2].

Market Size and Forecast

The market for VUITY is expected to experience substantial growth. According to DelveInsight's report, the market size for VUITY in the seven major markets (the United States, EU4, the United Kingdom, and Japan) is forecasted to grow significantly from 2028 to 2032. The report provides detailed sales forecasts, competitive landscape analysis, and insights into market drivers and barriers[1].

Competitive Landscape

VUITY operates within a competitive ophthalmic drugs market. The global ophthalmic drugs market is anticipated to grow at a CAGR of 5.5% from 2022 to 2028, driven by the rising prevalence of eye-related disorders and increasing research and development activities. VUITY's competitive positioning is enhanced by its unique status as the first FDA-approved eye drop for presbyopia, setting it apart from other treatments[1][4].

Clinical and Regulatory Milestones

VUITY's clinical trials, particularly the GEMINI 1 trial, have been pivotal in its approval and market success. The trial results, published in March 2022, demonstrated the efficacy and safety of VUITY, further bolstering its market position. Regulatory milestones, including the FDA approval for a twice-daily drop in March 2023, extend the duration of its effect up to 9 hours, enhancing patient compliance and satisfaction[2][4].

Financial Trajectory

The financial trajectory for VUITY is promising, given the growing demand for ophthalmic treatments. The U.S. ophthalmic drugs market, where VUITY is a key player, was estimated at USD 15.53 billion in 2023 and is expected to grow at a CAGR of 7.4% from 2024 to 2030. The increasing prevalence of eye-related disorders and the aging population are significant drivers of this growth[4].

Market Drivers

Several factors are driving the market growth for VUITY:

• Increasing Prevalence of Presbyopia: As the global population ages, the incidence of presbyopia is rising, creating a larger market for treatments like VUITY.
• New Product Launches: The approval and launch of VUITY have filled a critical gap in the treatment of presbyopia, attracting significant market attention.
• Direct-to-Consumer Advertising: Effective advertising campaigns have significantly increased public awareness and interest in VUITY.
• Regulatory Approvals: Additional approvals, such as the twice-daily drop, enhance the product's appeal and extend its market reach[1][2][4].

Market Barriers

Despite the positive outlook, there are some barriers to consider:

• Side Effects: Public concerns about side effects, such as retinal detachment, may impact adoption rates.
• Cost: The cost of VUITY could be a barrier for some patients, although increasing healthcare coverage is mitigating this issue.
• Competitive Market: The ophthalmic drugs market is highly competitive, with other treatments and emerging therapies vying for market share[2][4].

Ocular Drug Delivery Market Context

The broader ocular drug delivery market is also experiencing significant growth. This market was valued at $67.7 billion in 2022 and is estimated to reach $115.5 billion by 2032, growing at a CAGR of 5.5% from 2023 to 2032. The rise in prevalence of eye diseases and advancements in drug delivery technologies are key drivers of this growth[3].

Key Players and Initiatives

Allergan, as part of AbbVie, is a major player in the ophthalmic drugs market. Other key players, such as Harrow and Bausch + Lomb, are also launching new products and initiating clinical trials to address various ocular diseases. These initiatives are expected to further drive market growth and innovation[4].

Conclusion

VUITY is poised for significant market growth driven by its unique position as the first FDA-approved eye drop for presbyopia, increasing public awareness, and favorable regulatory milestones. As the ophthalmic drugs market continues to expand, VUITY is well-positioned to capture a substantial share, offering a promising financial trajectory for AbbVie.

Key Takeaways

• VUITY is the first FDA-approved eye drop treatment for presbyopia.
• The drug has seen significant public interest and awareness driven by direct-to-consumer advertising.
• Market forecasts indicate substantial growth for VUITY from 2028 to 2032.
• The broader ophthalmic drugs market is growing at a CAGR of 7.4% from 2024 to 2030.
• Regulatory approvals and new product launches are key drivers of market growth.

FAQs

Q: What is VUITY prescribed for? A: VUITY is prescribed for treating presbyopia in adults, a condition characterized by the age-related decline in the eye's ability to focus on nearby objects[1].

Q: When was VUITY approved by the FDA? A: VUITY was approved by the FDA on October 29, 2021[5].

Q: What are the key drivers of the market growth for VUITY? A: Key drivers include increasing prevalence of presbyopia, new product launches, direct-to-consumer advertising, and regulatory approvals[1][2][4].

Q: What are some potential barriers to the adoption of VUITY? A: Potential barriers include concerns about side effects, cost, and competition from other treatments[2][4].

Q: How is the broader ocular drug delivery market performing? A: The ocular drug delivery market is expected to grow from $67.7 billion in 2022 to $115.5 billion by 2032, at a CAGR of 5.5% from 2023 to 2032[3].

Cited Sources

1. DelveInsight: "The Market share for VUITY by Abbvie Set to Experience Tremendous Growth by 2032."
2. PLOS ONE: "Google Search Trends to assess public interest in and concern regarding Vuity for presbyopia."
3. PharmiWeb: "Ocular Drug Delivery Market Updates 2024: Rise in Prevalence of Eye Diseases is Predicted to Cross to USD 115.5 Billion Market Revenue by 2032."
4. Grand View Research: "U.S. Ophthalmic Drugs Market Size | Industry Report, 2030."
5. BioSpace: "FDA Approves Allergan's VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%."