LUMIFY PRESERVATIVE FREE Drug Patent Profile

When do Lumify Preservative Free patents expire, and what generic alternatives are available?

Lumify Preservative Free is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-seven patent family members in sixteen countries.

The generic ingredient in LUMIFY PRESERVATIVE FREE is brimonidine tartrate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lumify Preservative Free

A generic version of LUMIFY PRESERVATIVE FREE was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for LUMIFY PRESERVATIVE FREE

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMIFY PRESERVATIVE FREE
DailyMed Link:	LUMIFY PRESERVATIVE FREE at DailyMed

Recent Clinical Trials for LUMIFY PRESERVATIVE FREE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch & Lomb Incorporated	Phase 3

See all LUMIFY PRESERVATIVE FREE clinical trials

Pharmacology for LUMIFY PRESERVATIVE FREE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

US Patents and Regulatory Information for LUMIFY PRESERVATIVE FREE

LUMIFY PRESERVATIVE FREE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes	11,596,600
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes	9,259,425
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes	8,293,742

International Patents for LUMIFY PRESERVATIVE FREE

See the table below for patents covering LUMIFY PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2865593
Croatia	P20141047
European Patent Office	2819674	COMPOSITIONS ET MÉTHODES POUR LE TRAITEMENT DE LA MIGRAINE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF MIGRAINE)
World Intellectual Property Organization (WIPO)	2020041282

Supplementary Protection Certificates for LUMIFY PRESERVATIVE FREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	C300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225

Market Dynamics and Financial Trajectory for LUMIFY Preservative Free

Introduction to LUMIFY Preservative Free

LUMIFY Preservative Free, the latest addition to the LUMIFY brand by Bausch + Lomb, has garnered significant attention in the ophthalmic care market. This product is the first and only over-the-counter (OTC) preservative-free eye drop with low-dose brimonidine tartrate, designed to treat ocular redness due to minor eye irritations[1][4].

Market Need and Demand

The global eye drops and lubricants market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.1%, reaching nearly $28.72 billion by 2030. This growth is driven by increasing investments in healthcare, high R&D expenditures, and the rising prevalence of ophthalmic disorders such as age-related macular degeneration, cataract, diabetic retinopathy, and glaucoma[3].

Target Market and Consumer Segment

LUMIFY Preservative Free is tailored for consumers who experience sensitivities to preservatives, a common issue in traditional eye drop formulations. This product addresses a specific need in the market, providing a convenient on-the-go option in single-use vials, expected to be available at major retailers in early 2025[1][4].

Clinical Efficacy and Safety

Clinical trials have shown that LUMIFY Preservative Free significantly reduces ocular redness within one minute and provides relief for up to eight hours. The product has a low incidence of side effects, such as rebound redness and loss of efficacy over time, when used as directed[1][4][5].

Competitive Landscape

The introduction of LUMIFY Preservative Free comes at a time when the market is seeing increased competition. Lupin Limited, a multinational generic pharmaceutical company, has received tentative FDA approval for its generic version of LUMIFY (brimonidine tartrate ophthalmic solution 0.025%). However, the generic version is currently held back by patent and exclusivity issues, giving Bausch + Lomb a temporary market advantage[2].

Regulatory Approvals

The FDA approval of LUMIFY Preservative Free in April 2024 marks a significant milestone for Bausch + Lomb. This approval underscores the product's safety and efficacy, reinforcing its position in the market. The original LUMIFY product, approved in December 2017, has already established a strong presence, and the preservative-free version is expected to further expand the brand's reach[1][4].

Manufacturing and Distribution

LUMIFY Preservative Free will be manufactured by Bausch + Lomb and distributed through major retailers. The single-use vial format is designed for convenience and portability, catering to the needs of consumers who require quick and effective relief from ocular redness[1][4].

Financial Implications

The approval and upcoming launch of LUMIFY Preservative Free are expected to positively impact Bausch + Lomb's financial trajectory. Given the growing demand for eye care products and the specific need for preservative-free formulations, this product is likely to contribute significantly to the company's revenue. The absence of immediate generic competition due to patent and exclusivity issues further solidifies the financial prospects for LUMIFY Preservative Free[1][2][4].

Market Expansion and Growth Opportunities

The global eye drops and lubricants market is not only growing in North America but also expanding rapidly in the Asia Pacific region. This expansion is driven by the fast growth of healthcare infrastructure, high prevalence of ophthalmic diseases, and increasing healthcare initiatives by governments. Bausch + Lomb can leverage these trends to expand the market reach of LUMIFY Preservative Free beyond the U.S. market[3].

Consumer Preference and Satisfaction

Consumer preference for preservative-free products is on the rise, driven by concerns about the long-term effects of preservatives on the ocular surface. LUMIFY Preservative Free addresses this concern, offering a safe and effective solution that aligns with consumer preferences. Positive feedback from healthcare professionals, such as Dr. Melissa Toyos, who recommend LUMIFY to their patients, further enhances consumer trust and satisfaction[1][4].

Competitive Strategy

Bausch + Lomb's strategy involves differentiating LUMIFY Preservative Free through its unique formulation and clinical efficacy. By targeting consumers with preservative sensitivities, the company aims to capture a niche market segment. Additionally, the company's investment in marketing and distribution will be crucial in maintaining market share and expanding the product's reach[1][4].

Future Outlook

The future outlook for LUMIFY Preservative Free is promising, given the growing demand for eye care products and the specific advantages of this preservative-free formulation. As the market continues to evolve, Bausch + Lomb will need to stay ahead of competitors and adapt to changing consumer needs to maintain its market position.

"LUMIFY Preservative Free significantly reduces redness within one minute and lasts up to eight hours," said John Ferris, executive vice president, Consumer, Bausch + Lomb[1].

Key Takeaways

• First and Only Preservative-Free OTC Eye Drop: LUMIFY Preservative Free is the first OTC preservative-free eye drop with low-dose brimonidine tartrate.
• Clinical Efficacy: Reduces ocular redness within one minute and provides relief for up to eight hours.
• Target Market: Consumers with sensitivities to preservatives.
• Competitive Advantage: Temporary market exclusivity due to patent and exclusivity issues holding back generic competition.
• Financial Prospects: Expected to positively impact Bausch + Lomb's revenue.
• Market Expansion: Opportunities for growth in North America and the Asia Pacific region.

FAQs

What is LUMIFY Preservative Free?

LUMIFY Preservative Free is an over-the-counter preservative-free eye drop with low-dose brimonidine tartrate, designed to treat ocular redness due to minor eye irritations.

When will LUMIFY Preservative Free be available?

LUMIFY Preservative Free is expected to be available for purchase at major retailers in early 2025.

What are the benefits of using LUMIFY Preservative Free?

It significantly reduces ocular redness within one minute and provides relief for up to eight hours, with a low incidence of side effects.

Is there a generic version of LUMIFY available?

Lupin Limited has received tentative FDA approval for a generic version, but it is currently held back by patent and exclusivity issues.

How does LUMIFY Preservative Free differ from other eye drops?

It is the first and only OTC preservative-free eye drop with low-dose brimonidine tartrate, making it a unique solution for consumers with preservative sensitivities.

Sources

1. Chain Drug Review: Bausch + Lomb gets FDA approval of LUMIFY Preservative Free redness reliever eye drops.
2. Glance: FDA grants tentative approval for Lupin's Lumify generic eye drops.
3. Maximize Market Research: Eye Drops and Lubricants Market - Global Industry Analysis.
4. ChemDiv: FDA approves preservative-free version of Lumify redness-reliever eye drops.
5. IOVS: Evaluation of the Efficacy of a Novel Preservative-Free Formulation of Brimonidine Tartrate Ophthalmic Solution.