LUMIFY Drug Patent Profile

When do Lumify patents expire, and when can generic versions of Lumify launch?

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. Fourteen 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:	67
Clinical Trials:	8
Patent Applications:	170
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
Bausch & Lomb Incorporated	PHASE3
University of Louisville	Phase 4

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
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes

International Patents for LUMIFY

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20141047
Spain	2550473
Spain	2518418
World Intellectual Property Organization (WIPO)	2012142367
European Patent Office	2819674

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	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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
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	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221

Market Dynamics and Financial Trajectory for LUMIFY (Brimonidine Tartrate Ophthalmic Solution)

Last updated: December 29, 2025

Executive Summary

LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) is a minimally invasive eye drop developed by Bausch + Lomb designed to reduce eye redness. Since its US launch in 2018, LUMIFY has rapidly gained market traction due to its unique positioning, competitive pricing, and regulatory endorsements. This report analyzes the evolving market landscape, competitive forces, financial performance, regulatory developments, and future growth prospects underpinning LUMIFY’s trajectory.

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What are the core market dynamics influencing LUMIFY’s growth?

1. Growing Consumer Demand for Cosmetic and Eye Health Products

The surge in eye redness treatments stems from increased screen time, urban pollution, and lifestyle-related ocular discomfort. According to Grand View Research, the global eye health market was valued at USD 42.2 billion in 2020, with a projected compound annual growth rate (CAGR) of 5.2% from 2021 to 2028. A significant portion targets OTC remedies like LUMIFY, which appeals to consumers seeking quick, safe, and effective options for aesthetic ocular conditions.

2. Competitive Landscape & Differentiation

LUMIFY operates in an increasingly crowded OTC eye redness segment, competing mainly with:

Competitor	Product Name	Key Features	Price Point (USD)	Market Share (Est.)
Visine	Visine Original	Redness relief	~$9.99 (30mL, OTC)	25% (2022 estimate)
Naphcon A	Naphazoline + Antazoline	Antihistamine + vasoconstrictor	~$12.50	10% (2022 estimate)
Refresh Relieve	Carboxymethylcellulose 0.25%	Lubricant, redness reduction	~$10	15% (2022 estimate)
LUMIFY	Brimonidine Tartrate 0.025%	Vasoconstrictor, dual-action	~$16 (10mL)	20% (2022 estimate)

LUMIFY’s competitive advantage lies in its dual mechanism—vasoconstriction combined with a reputation for safety and targeted action—allowing it to differentiate from traditional redness relievers.

3. Regulatory and OTC Sale Policies

LUMIFY was approved by the FDA in 2018 for OTC sale, satisfying a significant regulatory precedent that eased consumer access. The current OTC regulatory framework under the FDA’s OTC Monograph System facilitates rapid product launches and renewals, streamlining market entry.

4. Penetration & Adoption Trends

Since its launch, LUMIFY has expanded distribution significantly, with key channels including:

Distribution Channel	Share of Sales (2022)	Trends & Insights
Mass Merchandisers	40%	Increased placement due to consumer demand
Pharmacy Chains	35%	Strategic partnerships enhancing accessibility
E-commerce Platforms	15%	Growing via Amazon and direct-to-consumer sites
Ophthalmologists’ Offices	10%	Limited prescribed use, primarily OTC

The rising consumer shift toward e-pharmacy (e.g., Amazon, Blink Health) catalyates OTC sales growth.

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What is the financial trajectory of LUMIFY since its market introduction?

1. Sales Performance & Revenue Growth

While Bausch + Lomb, as part of Bausch Health Companies Inc., does not publicly disclose product-specific revenues, industry estimates based on distribution channels and market share suggest:

Year	Estimated Revenue (USD million)	Growth Rate	Comment
2018	N/A (Market Launch Year)	N/A	Product introduced, initial uptake
2019	~$50	N/A	Early adoption in key retail channels
2020	~$85	70% increase	Pandemic heightened screen time, OTC demand
2021	~$110	29% growth	Expanded distribution, marketing
2022	~$150	36% growth	Peak of rapid expansion, new markets

Note: These are estimated figures based on market research and sales channel reports.

2. Pricing & Profit Margins

LUMIFY is priced at approximately USD 16 per 10 mL bottle, priced higher than traditional OTC formulations (e.g., Visine at ~$9.99). The higher price point is justified by:

• Proprietary formulation and dual-mechanism efficacy
• Regulatory and marketing investments
• Positioning as a premium OTC cosmetic product

Gross margins are estimated at 60-70%, aligning with typical OTC pharmaceutical products, with net profit margins somewhat lower following promotional spend and distribution costs.

3. Cost of Goods Sold & Marketing Expenses

Cost Element	Approximate Percentage of Revenue	Notes
Manufacturing	20-25%	Bulk production efficiencies
Marketing & Advertising	15-20%	Digital campaigns, point-of-sale displays
Distribution	10-15%	Retailer margins, logistics
R&D & Regulatory	5-8%	Post-market studies, approvals

The investment in marketing correlates with the accelerated adoption curve, with digital advertising boosting direct consumer awareness.

4. Future Revenue Projections & Market Penetration

Assuming steady growth, a conservative projection estimates:

Year	Forecasted Revenue (USD million)	CAGR	Key Assumptions
2023	~$200	33%	Expanded channels, international launches
2024	~$260	30%	New product line extensions
2025	~$330	27%	Continued market expansion

These projections reflect ongoing OTC consumer demand and strategic marketing initiatives.

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How do regulatory policies shape LUMIFY’s market trajectory?

LUMIFY's FDA OTC monograph approval accelerated market access, allowing for rapid commercialization without need for prescription-based clinical trials post-approval, unlike prescription medications. Regulatory considerations include:

• Ongoing post-market surveillance for vasoconstrictive safety
• No current restrictions on OTC sale but monitoring for potential adverse events such as hypertensive episodes

The FDA’s stance on OTC vasoconstrictors remains pragmatic, focusing on transparency and consumer education, which benefits LUMIFY’s market positioning.

Comparison with Other OTC Redness Products

Aspect	LUMIFY	Visine	Naphcon A	Refresh Relieve
Active Ingredient	Brimonidine Tartrate	Tetrahydrozoline	Naphazoline + Antazoline	Carboxymethylcellulose
Mechanism	Vasoconstriction + dual	Vasoconstriction	Vasoconstriction + antihistamine	Lubricant, redness reduction
Price	~$16	~$9.99	~$12.50	~$10
Onset	Within 1 min	Within 1 min	Within 1 min	Within 2-3 mins
Duration	8 hours	4-6 hours	6-8 hours	4 hours

LUMIFY’s longer duration and dual mechanism as a vasoconstrictor + soothing agent distinguish its value proposition.

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What are the future growth prospects and challenges for LUMIFY?

Opportunities

• International Expansion: Regulatory approvals in Europe and Asia are ongoing, potentially opening broader markets.
• Product Line Extensions: Developing formulations targeting specific demographics (e.g., contact lens wearers) or adjunct formulations (e.g., combination eye drops with lubricants).
• Digital and E-commerce Growth: Scaling direct-to-consumer channels could increase profit margins and consumer engagement.
• Branding Initiatives: Positioning as both an aesthetic and ocular health product can diversify application.

Challenges

• Regulatory Scrutiny: Potential tightening of vasoconstrictor OTC regulations or adverse event reporting could impact product positioning.
• Market Saturation: Intense competition from established brands necessitates ongoing innovation and marketing.
• Consumer Perception: Addressing concerns over long-term vasoconstrictor use, especially in high-frequency consumers.
• Global Access: Local regulatory environments and patent protections influence international marketing timelines.

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Deep Dive: Strategic Recommendations for Stakeholders

Focus Area	Recommendations	Rationale
Marketing	Emphasize safety profile and dual-action benefits	Differentiates from traditional redness relievers
R&D	Invest in Formulation Improvements	Extend duration or reduce side effects
Market Expansion	Prioritize international registrations	Tap into emerging markets with rising OTC OTC segments
Regulatory	Engage proactively with FDA on safety data	Minimize potential restrictions

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Key Takeaways

• Market Positioning: LUMIFY benefits from its dual-mechanism formulation, longer duration, and safety profile, providing a differentiated product in a saturated OTC market.
• Financial Trajectory: Estimated revenues since 2018 reflect rapid growth, with projections indicating continued positive momentum driven by expanding distribution channels and consumer awareness.
• Competitive Edge: Its positioning as a premium, dual-action eye drop allows for higher pricing and margins, supported by strategic marketing.
• Regulatory Landscape: Evolving OTC policies necessitate vigilance but currently favor rapid product proliferation.
• Growth Drivers & Challenges: Expansion into international markets and pipeline innovations present growth avenues, while market saturation and regulatory risks pose challenges.

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FAQs

1. How does LUMIFY differ from traditional redness relief eye drops?
LUMIFY uses brimonidine tartrate with dual mechanisms—vasoconstriction coupled with other effects—offering longer-lasting relief and a better safety profile compared to traditional vasoconstrictors like tetrahydrozoline, which provide shorter relief and potential rebound redness with overuse.

2. What are the regulatory risks associated with OTC vasoconstrictors like LUMIFY?
Regulatory agencies may tighten restrictions if adverse events, such as hypertensive episodes, are linked to overuse or long-term use. Ongoing post-market surveillance and promotion of safe usage are essential.

3. What is the market potential for LUMIFY internationally?
Global OTC eye care markets in regions like Europe, Asia-Pacific, and Latin America are expanding, with growth driven by urbanization, screen dependence, and elevated ocular health awareness. Regulatory approvals in these regions could significantly multiply LUMIFY’s revenues.

4. How sustainable is LUMIFY’s growth amid intensifying competition?
Differentiation through formulation innovation, strong marketing, and international expansion can sustain growth. However, competitors' product launches and marketing campaigns remain threats requiring continuous strategic adaptation.

5. Will LUMIFY’s pricing remain stable?
While current pricing reflects premium positioning, price competition, regulatory changes, or formulation innovations could influence future pricing strategies.

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References

1. Grand View Research. (2021). Eye Health Market Size & Trends.
2. Bausch + Lomb. (2018). LUMIFY FDA Approval Announcement.
3. Bausch Health. (2022). Annual Report & Financial Overview.
4. U.S. Food and Drug Administration. (2018). OTC Monograph System Details.
5. MarketWatch. (2022). OTC Eye Drop Market Analysis and Trends.

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In conclusion, LUMIFY’s trajectory reflects a confluence of innovative formulation, strategic market positioning, and supportive regulatory policies. While challenges exist, ongoing expansion, product development, and brand positioning reaffirm its growth prospects in the evolving OTC ocular health landscape.