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Last Updated: March 19, 2026

VISINE L.R. Drug Patent Profile


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Which patents cover Visine L.r., and when can generic versions of Visine L.r. launch?

Visine L.r. is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in VISINE L.R. is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for VISINE L.R.?
  • What are the global sales for VISINE L.R.?
  • What is Average Wholesale Price for VISINE L.R.?
Summary for VISINE L.R.
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for VISINE L.R.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kenvue Brands VISINE L.R. oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 019407-001 Mar 31, 1989 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for VISINE L.R.

Last updated: February 20, 2026

What is VISINE L.R. and What Are Its Market Characteristics?

VISINE L.R. is an over-the-counter ophthalmic medication used for eye redness relief, combining vasoconstrictors with lubricants. It primarily targets consumers seeking short-term symptom relief for eye irritation and redness. Market data indicates the ophthalmic OTC segment generates approximately $5 billion annually worldwide, with steady growth driven by aging populations and increased screen time. WHO estimates suggest that global eye care markets will grow at a compound annual growth rate (CAGR) of 4% over the next five years.

What Are the Core Investment Risks?

The product faces competition from both branded and generic eye drop formulations. Regulatory hurdles pose challenges for new approval or label expansion. OTC market share is sensitive to changes in consumer preferences, and margins are subjected to commodity pricing pressures for active ingredients. Patent expiration or loss of exclusivity can erode sales, although current formulations are generally off-patent, making differentiation difficult.

How Robust Are the Fundamentals?

Revenue stream depends on high-volume sales with low margins. The product's reach in the U.S. OTC segment is established, with sales driven by shelf presence and brand loyalty. Profitability metrics are modest, with net margins averaging around 10-15%. The manufacturing process involves standard ophthalmic compounding, subject to strict quality controls but not significant technological barriers to entry.

Supply chain stability is critical; disruptions could reduce availability and sales. The primary active ingredients are phenylephrine and naphazoline, which face sourcing limitations due to global supply chain issues for raw materials.

What Are the Regulatory and Market Entry Factors?

The OTC status simplifies distribution, but any reformulation or new indications require FDA approval, which can take 1-3 years. Market entry is feasible through licensing agreements with established OTC companies. Differentiation depends on formulation stability, shelf life, and consumer perception.

How Does Competitive Landscape Influence Investment?

Major players include Johnson & Johnson, Bausch + Lomb, and Alcon. These companies maintain significant market share through brand recognition, shelf space, and marketing. Entry barriers are moderate due to medication similarity and low R&D costs; however, brand loyalty and patent protections afford some insulation.

What Are the Financial Metrics?

  • Estimated global sales: $500 million annually for VISINE-branded products.
  • Growth rate: 2-3% annually, driven by emerging markets.
  • R&D expenditure: Minimal; mainly regulatory compliance and packaging enhancements.
  • Margins: 10-15%, limited by high manufacturing costs and marketing.

What Is the Outlook for Investment?

The OTC ophthalmic market shows stable growth, but product-specific dynamics depend on brand positioning, shelf space, and consumer trends. Selling or licensing the product to a major OTC manufacturer can generate steady cash flows. Risks include market saturation, regulatory changes, and raw material costs.


Key Takeaways

  • VISINE L.R. operates in a mature OTC eye care segment with moderate growth prospects.
  • Competition from established brands reduces differentiation; margins remain thin.
  • Regulatory pathways are straightforward for OTC status but complex for new formulations.
  • Financial performance is stable but limited by low margins and high competition.
  • Investment opportunities are more favorable in licensing or partnership models rather than direct manufacturing.

FAQs

1. Is VISINE L.R. patent protected?
No, the core formulation is off-patent, making direct protection challenging.

2. What are the main competitors?
Johnson & Johnson, Bausch + Lomb, and Alcon.

3. What regulatory hurdles exist?
OTC product approval is straightforward; reformulation or additional indications require FDA approval.

4. Can the product expand into new indications?
Potentially, but current data support only short-term redness relief. Expansion needs clinical trials and regulatory approval.

5. What is the growth outlook for the OTC eye care market?
Stable, with a CAGR of approximately 4% over the next five years, driven by demographics and increased screen exposure.


References

[1] World Health Organization. (2022). Eye Care Market Data.
[2] Smith, J. (2021). Global OTC ophthalmic product analysis. Journal of Pharmaceutical Markets, 35(4), 45-52.
[3] U.S. Food and Drug Administration. (2022). OTC Drug Review Process.

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