Last Updated: May 12, 2026

VISINE Drug Patent Profile


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

Visine is a drug marketed by Kenvue Brands and is included in two NDAs.

The generic ingredient in VISINE 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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Summary for VISINE
Recent Clinical Trials for VISINE

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

SponsorPhase
Massachusetts Eye and Ear InfirmaryPhase 2

See all VISINE clinical trials

US Patents and Regulatory Information for VISINE

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 naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 020485-001 Jan 31, 1996 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 (naphazoline/antazoline ophthalmic)

Last updated: April 25, 2026

What is VISINE’s product positioning in the eye-care market?

VISINE is a branded, over-the-counter (OTC) ophthalmic franchise aimed at short-term relief of eye redness. Commercially, the portfolio is anchored in fast-onset vasoconstriction/antihistamine combinations and competes in a crowded OTC category that also includes single-ingredient decongestants and lubricating drops.

Core therapeutic intent (consumer-facing)

  • Redness relief: vasoconstriction-based action (commonly associated with naphazoline-containing formulations).
  • Irritation/allergy symptom relief: combination products typically add an antihistamine component (commonly associated with antazoline-containing formulations).
  • Symptom-driven purchase: repeat purchases tied to seasonality (allergies) and episodic use (irritation).

Competitive landscape (category dynamics)

The redness/itching segment is structurally exposed to:

  • Brand-to-generic substitution: decongestant/antihistamine eye drops have many lower-priced alternatives.
  • Formulation switching: consumers trade within redness-relief formats and between “redness vs dryness” use-cases.
  • Channel concentration: OTC eye care relies on mass retail, warehouse clubs, and pharmacy chains; promotional intensity drives velocity.

How does demand move over time (seasonality and use-patterns)?

VISINE demand typically tracks two demand drivers:

  1. Seasonal allergy intensity
    • Peak usage occurs during spring to early summer and again in fall, depending on geography and pollen cycles.
  2. Non-seasonal irritation
    • Dryness from screens, air conditioning, contact lens use, and smoke exposure drives off-season demand for similar “redness/irritation” products.

Market behavior that shapes quarterly sales

  • Promotional spikes: major retailers run markdowns and feature deals that pull sales forward.
  • Shelf competition: redness-relief SKUs compete at the eye-care end-cap; unit share can change quickly with retailer planograms.
  • Substitution to lubricants: consumers increasingly treat “redness” as dryness-related discomfort, lifting sales of artificial tears that can displace some decongestant purchases.

What pricing and promo dynamics matter for VISINE profitability?

VISINE’s financial trajectory depends on the spread between:

  • Wholesale acquisition cost and retail net pricing (retailer mix, trade spend).
  • Trade allowances and promotions required to defend shelf share.
  • Volume-driven leverage from high-velocity brands in mass/pharmacy.

Margin sensitivity (what tends to move)

  • Retail net price declines when competitors outprice or when retailers increase private-label share.
  • Gross margin compression can occur with higher trade spend.
  • Cost inflation pass-through is limited by consumer price elasticity in OTC eye care.

What are the regulatory and compliance forces affecting market access?

VISINE is an OTC ophthalmic product. Regulatory risk is generally lower than prescription drug portfolios, but OTC ophthalmics face:

  • Labeling compliance and OTC monograph alignment (where applicable to the ingredients).
  • Safety surveillance driven by post-market complaints (redness relief products face scrutiny over misuse and overuse).

These dynamics usually affect product continuity more than pricing power, but they can influence retailer confidence and distribution continuity.

How does competition influence VISINE unit and share over the cycle?

Competition in redness-relief eye drops includes:

  • Single-ingredient vasoconstrictors (often lower price).
  • Combination antihistamine/decongestant products (similar claim set).
  • Artificial tears and “redness relief” lubricants (shift the consumer away from vasoconstrictors).

Practical impact on VISINE’s market share

  • When mass retail expands private label redness relief, VISINE faces unit share erosion.
  • When allergy season runs strong, combination products capture incremental demand, but competitors also benefit.
  • When consumers prioritize comfort and dryness relief, VISINE’s relative attractiveness can decline unless the portfolio includes dryness-related adjuncts.

Financial trajectory: what the likely revenue and earnings pattern looks like

VISINE is a mature OTC brand, so the financial profile typically shows:

  • Stable revenue base with seasonal peaks
  • Moderate growth driven by distribution, promotions, and mix
  • Margin volatility driven by trade spend and pricing actions

Given VISINE’s mature category position, the financial trajectory is usually less about new clinical differentiation and more about:

  • Retail execution
  • SKU mix management
  • Promotion intensity and retailer deal calendars
  • Competing private-label pricing

Typical year-to-year shape (mature OTC brand pattern)

  • Spring/fall spikes pull quarterly comparisons upward.
  • Promotion cycles create volatility in net sales and gross margin.
  • Category shift toward lubricants can cap structural growth even when total eye-care demand rises.

Where is the biggest financial risk for VISINE?

The main risk drivers are category-level and channel-level rather than molecular-level:

  • Private label expansion in redness relief.
  • Consumer substitution to lubricants and “comfort” formats.
  • Trade spend increases to maintain shelf space and feature rank.
  • Regulatory labeling changes that can force reformulation or reprint cycles (rare, but disruptive).

What investment-relevant signals should be monitored for VISINE?

For business decision-making, the highest signal items are those that directly affect net price, unit share, and channel velocity:

Signals tied to revenue momentum

  • Retail scanner trends in “redness relief” and “itchy eye” categories
  • Feature participation in mass retail and drugstore chains
  • SKU mix shifts toward multi-symptom products

Signals tied to margin trajectory

  • Trade spend as a percent of net sales
  • Price gap vs category leaders and private label
  • Gross margin sensitivity to freight/inputs (especially for packaging-heavy OTC lines)

Signals tied to durability

  • Share loss or stabilization around allergy peaks
  • Shelf availability and planogram outcomes
  • Return rates and complaint rates that could pressure retailer confidence

Competitive benchmarking: what determines whether VISINE outperforms?

VISINE outperformance usually requires one or more of these conditions:

  • Stronger relative net pricing after promotions.
  • Better distribution depth (more facings and higher velocity SKUs).
  • Higher conversion of traffic shoppers into brand purchasers through retail deals.
  • Portfolio coverage that matches consumer symptom framing (redness vs dryness vs allergy).

If VISINE cannot defend any one of these, the brand typically reverts to category growth or declines on private label.

What does the market structure imply for near-term financial outlook?

The near-term outlook for a mature branded OTC redness-relief franchise is typically:

  • Qualitative growth that is promo- and season-dependent.
  • Limited structural margin upside because price competition forces trade and retailer concessions.
  • Earnings volatility tied to deal intensity rather than sustained demand shock.

The financial trajectory is therefore best treated as a channel execution problem with a seasonal demand overlay, not as a sustained innovation-driven growth story.


Key Takeaways

  • VISINE competes in a mature OTC redness-relief category with high substitution risk from private label and similar ingredient products.
  • Market demand is driven mainly by seasonality (allergy peaks) and episodic irritation use-cases, with quarterly volatility dominated by retailer promotions.
  • Financial trajectory is typically net-price and trade-spend sensitive, with margin compression risks if competitive pricing intensifies.
  • The biggest business risks are private label share gains and consumer substitution toward lubricants/comfort formats.
  • Near-term performance is most likely to track retail execution, feature activity, and SKU mix, not breakthrough demand.

FAQs

  1. Is VISINE growth primarily innovation-led or promotion-led?
    Promotion and distribution execution generally drive the near-term sales path for mature OTC redness-relief brands, with seasonality amplifying quarterly changes.

  2. What seasonal periods most influence VISINE demand?
    Demand commonly peaks during spring to early summer and again in fall, aligned with allergy patterns, with additional off-season spikes from irritant exposure.

  3. How does private label affect VISINE’s unit economics?
    Private label pressure typically compresses net price and forces higher trade spend to defend shelf share, which can reduce gross margin.

  4. Does consumer shift to dryness products change VISINE’s competitive position?
    Yes. When “redness” is reframed as dryness or comfort, consumers may prefer artificial tears, reducing the relative pull of vasoconstrictor-based products.

  5. What KPIs best predict VISINE’s earnings trajectory?
    Scanner-based category share, retail net price after promotions, trade spend intensity, and SKU mix are the highest-signal indicators.


References (APA)

[1] FDA. (n.d.). Over-the-counter (OTC) drug products. U.S. Food and Drug Administration. https://www.fda.gov/drugs/over-counter-otc-drugs
[2] IQVIA. (n.d.). Eye care and OTC market coverage and tracking (industry reports). IQVIA. https://www.iqvia.com/insights

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