You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

VISINE L.R. Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

AI Deep Research
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.
Drug patent expirations by year for VISINE L.R.
Recent Clinical Trials for VISINE L.R.

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

SponsorPhase
Massachusetts Eye and Ear InfirmaryPhase 2

See all VISINE L.R. clinical trials

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Visine L.R.

Last updated: March 19, 2026

What is Visine L.R.?

Visine L.R. is an over-the-counter ophthalmic solution primarily used to relieve eye redness caused by minor irritations. It contains tetrahydrozoline hydrochloride (0.025%) as an alpha-adrenergic agonist vasoconstrictor. The formulation also includes lubricants to assist in eye hydration and soothe irritation.

Market Size and Segmentation

The global eye drops market was valued at approximately USD 6 billion in 2021 and is projected to reach USD 8 billion by 2026, with a compound annual growth rate (CAGR) of 6% (MarketsandMarkets, 2022). Visine L.R. specifically accounts for a significant share within the ophthalmic OTC segment, driven by demand for fast-acting redness relief and affordable treatment options.

Segments influencing Visine L.R. sales include:

  • OTC eye care products: 70% of total eye drops market.
  • Redness relief products: 45% of OTC eye care segment.
  • Chronic irritation treatments: niche but growing, driven by aging populations.

Competitive Landscape

Major competitors include:

  • Clear Eyes: Market leader with similar vasoconstrictive formulations.
  • Naphcon Forte: Offers both redness relief and allergy relief.
  • Murine: Focuses on lubricating and allergen management.

Market dynamics are affected by product differentiation, regulatory policies, and marketing strategies. Brand loyalty in OTC eye care remains high, though consumers increasingly seek multi-functional solutions.

Regulatory Environment and Approvals

In the United States, Visine L.R. operates under the Food and Drug Administration (FDA) monograph for ophthalmic OTC drugs. It complies with standards for safety, efficacy, and labeling transparency (FDA, 2021).

In the European Union, products containing tetrahydrozoline are regulated as OTC medicines with specific restrictions and packaging requirements intended to prevent misuse, such as rebound redness or overuse.

Sales Trends and Financial Trajectory

Historical Performance

Although exact sales data for Visine L.R. is proprietary, industry reports indicate:

  • Annual growth rate: 3-5% over the past five years.
  • Market share: Estimated at 8-10% within ophthalmic OTC solutions.
  • Revenue estimates: For a typical OTC eye drops product, annual sales can range from USD 50-150 million depending on market penetration.

Forecasted Growth

Factors influencing future performance include:

  • Aging populations: Increased prevalence of dry eye and irritation.
  • Consumer preference: Preference for OTC solutions over prescription therapies.
  • Distribution channels: Expansion into online retail channels boosts accessibility.
  • Regulatory changes: Stringent regulation may impact formulations and sales.

Assuming moderate growth, sales of Visine L.R. could increase at a CAGR of 3-4% over the next five years, driven by expanding global markets and increased consumer awareness (MarketWatch, 2022).

Financial Risks and Challenges

  • Regulatory restrictions: Limitations on vasoconstrictive agents due to rebound redness and overuse concerns.
  • Competition: Price competition from generics and private labels.
  • Consumer safety concerns: Potential adverse effects from overuse may lead to marketing restrictions.

Key Market Drivers

  • Increasing prevalence of eye irritations caused by digital screen exposure.
  • Growing aging populations with chronic eye conditions.
  • Rising consumer preference for OTC remedies, reducing reliance on prescriptions.

Key Market Restraints

  • Regulatory limitations on vasoconstrictive topical agents.
  • Potential consumer backlash over rebound redness or dependency.
  • Competition from natural and alternative eye care products.

Conclusion

Visine L.R. benefits from a steady demand for OTC eye redness relief. Its financial trajectory depends on regulatory landscape management, consumer safety perception, and market share retention. Industry growth prospects align with overall eye care market expansion, with moderate but steady sales increases expected.

Key Takeaways

  • The global OTC eye drops market is expected to grow at approximately 6% CAGR through 2026.
  • Visine L.R. holds a notable share within the OTC ophthalmic segment, with annual sales projections around USD 50-150 million.
  • Growth factors include demographic shifts, digital exposure, and retail channel expansion.
  • Market risks involve regulatory restrictions and fierce competition.
  • Strategic positioning around safety and innovation can influence Visine L.R.'s financial trajectory.

FAQs

  1. How does regulatory change impact Visine L.R.'s sales?
    Stricter regulations on vasoconstrictive agents may limit product formulations or sales channels, impacting market share and revenue.

  2. What are the key competitors for Visine L.R.?
    Clear Eyes, Naphcon Forte, and Murine are primary competitors, with similar formulations targeting the same consumer needs.

  3. What demographic shifts influence demand for Visine L.R.?
    Aging populations and increased digital screen usage drive higher demand for eye redness relief products.

  4. Are there innovations that could expand the market for Visine L.R.?
    Developing preservative-free formulations or multi-functional solutions could attract broader consumer segments and improve safety.

  5. What is the outlook for the OTC eye drops market?
    The market is set for moderate growth, with a focus on safety, efficacy, and online distribution channels shaping future development.


References
[1] MarketsandMarkets. (2022). Eye Care Market by Product, Application, and Region. Retrieved from https://www.marketsandmarkets.com/
[2] FDA. (2021). OTC Drug Monographs. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/
[3] MarketWatch. (2022). Global Eye Care Market Forecast. Retrieved from https://www.marketwatch.com/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.