LUMIFY Drug Patent Profile

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

Lumify is a drug marketed by Bausch And Lomb Inc and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in LUMIFY 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

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

Summary for LUMIFY

International Patents:	37
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	6
Patent Applications:	337
Drug Prices:	Drug price information for LUMIFY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMIFY
DailyMed Link:	LUMIFY at DailyMed

See drug prices for LUMIFY

Recent Clinical Trials for LUMIFY

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

Sponsor	Phase
Tulane University	Phase 4
University of Louisville	Phase 4
Bausch & Lomb Incorporated	Phase 3

See all LUMIFY clinical trials

Pharmacology for LUMIFY

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

Paragraph IV (Patent) Challenges for LUMIFY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUMIFY	Ophthalmic Solution	brimonidine tartrate	0.025%	208144	1	2021-07-12

US Patents and Regulatory Information for LUMIFY

LUMIFY is protected by four 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	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	8,293,742
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes	8,293,742
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	11,833,245
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	11,596,600
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	9,259,425

International Patents for LUMIFY

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

Country	Patent Number	Title	Estimated Expiration
Canada	2782817	COMPOSITIONS ET METHODES DE BLANCHIMENT DES YEUX (COMPOSITIONS AND METHODS FOR EYE WHITENING)
Croatia	P20141047
European Patent Office	2515917	BRIMONIDINE POUR BLANCHIMENT DES YEUX (BRIMONIDINE FOR EYE WHITENING)
Japan	5671459
European Patent Office	2819674	COMPOSITIONS ET MÉTHODES POUR LE TRAITEMENT DE LA MIGRAINE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF MIGRAINE)

Supplementary Protection Certificates for LUMIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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
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

LUMIFY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUMIFY

Introduction

LUMIFY, developed by Bausch + Lomb, is a groundbreaking over-the-counter (OTC) eye drop formulated with low-dose brimonidine tartrate 0.025% to relieve redness of the eye due to minor irritations. Since its launch in 2018, LUMIFY has made significant strides in the market, influencing both consumer behavior and the financial performance of its parent company.

Market Success and Innovation

LUMIFY was recognized by Nielsen's BASES as one of the top 25 breakthrough innovations in the U.S. in 2020, falling under the "Superstar" category for its exceptional sales and category growth. This recognition underscores its impact on the consumer packaged goods (CPG) space[1].

Market Share and Consumer Adoption

LUMIFY has achieved a dominant market position, capturing a 40% dollar share among redness relievers in the latest 52 weeks. It has also become the No. 1 eye doctor-recommended brand within the redness reliever category, with approximately 79% of doctor recommendations. The product has attracted over a million first-time users into the eye redness reliever category, significantly expanding the market[1].

Unique Selling Proposition

Unlike other redness relievers, LUMIFY selectively targets redness with a reduced risk of certain side effects such as rebound redness and loss of efficacy over time, when used as directed. This unique selling proposition has contributed to its widespread acceptance and loyalty among consumers[1].

Brand Expansion

The success of LUMIFY has led to the expansion of the brand. Bausch + Lomb has introduced additional products under the LUMIFY brand, including LUMIFY EYE ILLUMINATIONS, a line of specialty eye care products, and more recently, LUMIFY Preservative-Free redness reliever eye drops. These new products continue to build on the brand's reputation for effective and safe eye care solutions[4].

Competitive Landscape

The approval of a generic version of LUMIFY by Lupin Limited could potentially alter the competitive landscape. However, the FDA's tentative approval means that Lupin's generic will not be marketed in the U.S. until all patent or exclusivity issues are resolved, which may take several years. This delay provides Bausch + Lomb with continued market exclusivity for LUMIFY[4].

Financial Performance

The financial success of LUMIFY is reflected in Bausch + Lomb's overall revenue and profitability. For the full year 2023, Bausch + Lomb reported total revenue of $4.146 billion, an increase of 10% compared to 2022. The company's adjusted EBITDA for 2023 was $738 million, up from $720 million in 2022. The growth in revenue and profitability can be attributed in part to the strong performance of LUMIFY and other key products[5].

Segment Contribution

LUMIFY's contribution to Bausch + Lomb's revenue is significant, particularly within the consumer segment. The company's consumer business, which includes OTC products like LUMIFY, has seen substantial growth driven by innovative marketing strategies and new product launches. Bausch + Lomb's investment in direct-to-consumer advertising and sales force capabilities has further boosted the sales of LUMIFY and other consumer products[3].

International Growth

Bausch + Lomb's international business has also benefited from the success of LUMIFY. The company has reported growth in all regions, with international revenue increasing by 6% on an organic basis in 2023. This global expansion underscores the universal appeal and effectiveness of LUMIFY[3].

Future Outlook

Looking ahead, Bausch + Lomb is poised to continue leveraging the success of LUMIFY. The company plans to invest further in direct-to-consumer campaigns and sales force capabilities, which are expected to drive continued growth. Additionally, the recent launch of LUMIFY Preservative-Free eye drops is anticipated to further enhance the brand's market position[3].

Key Takeaways

• Market Dominance: LUMIFY has achieved a 40% dollar share among redness relievers and is the No. 1 eye doctor-recommended brand.
• Innovation: Recognized by Nielsen's BASES as a "Superstar" innovation for its sales and category growth.
• Unique Proposition: Selectively targets redness with reduced risk of side effects.
• Brand Expansion: Introduction of new products under the LUMIFY brand.
• Competitive Landscape: Generic version approval by Lupin, but delayed due to patent issues.
• Financial Performance: Significant contribution to Bausch + Lomb's revenue and profitability.
• International Growth: Growth in all regions, with a 6% increase in international revenue.

FAQs

Q: What makes LUMIFY unique compared to other redness relievers? A: LUMIFY is unique because it selectively targets redness with a reduced risk of certain side effects such as rebound redness and loss of efficacy over time, when used as directed.

Q: How has LUMIFY performed in terms of market share? A: LUMIFY has achieved a 40% dollar share among redness relievers and is the No. 1 eye doctor-recommended brand.

Q: What is the status of the generic version of LUMIFY? A: Lupin Limited has received tentative FDA approval for its generic version, but final approval is delayed due to patent or exclusivity issues.

Q: How has LUMIFY contributed to Bausch + Lomb's financial performance? A: LUMIFY has significantly contributed to Bausch + Lomb's revenue and profitability, with the company reporting a 10% increase in total revenue for 2023.

Q: What are Bausch + Lomb's plans for the LUMIFY brand in the future? A: Bausch + Lomb plans to continue investing in direct-to-consumer campaigns and sales force capabilities to drive further growth for the LUMIFY brand.

Sources

1. Nielsen's BASES Names LUMIFY® Eye Drops To 2020 U.S. BASES Top 25 Breakthrough Innovations List - PR Newswire
2. Lumen Technologies reports third quarter 2024 results - Lumen Technologies
3. BAUSCH HEALTH COMPANIES INC. AR 2023 - Bausch Health Companies Inc.
4. FDA grants tentative approval for Lupin's Lumify generic eye drops - Glance
5. Bausch + Lomb Announces Fourth-Quarter and Full-Year 2023 Results and Provides 2024 Guidance - Business Wire