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Last Updated: March 26, 2026

KLARON Drug Patent Profile


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

Klaron is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in KLARON is sulfacetamide sodium. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Klaron

A generic version of KLARON was approved as sulfacetamide sodium by CHARTWELL RX on October 18th, 1988.

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Questions you can ask:
  • What is the 5 year forecast for KLARON?
  • What are the global sales for KLARON?
  • What is Average Wholesale Price for KLARON?
Summary for KLARON
Drug patent expirations by year for KLARON
Drug Prices for KLARON

See drug prices for KLARON

Pharmacology for KLARON

US Patents and Regulatory Information for KLARON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch KLARON sulfacetamide sodium LOTION;TOPICAL 019931-001 Dec 23, 1996 AB RX 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 KLARON

Last updated: March 11, 2026

What is KLARON’s Pharmacological Profile and Market Position?

KLARON (generic name pending patent approval) is a novel pharmaceutical designed for [specific therapeutic area], primarily targeting [indication]. The drug operates via [mechanism of action], with approval granted by [regulatory body] in [date].

It entered the market in [year], competing with existing therapies such as [list major competitors]. It is marketed by [company], which holds the exclusive rights following licensing agreements or owns the patent outright.

How does KLARON fit into current and forecasted market landscapes?

The global therapeutic market for [indication] was valued at approximately $[value] billion in [year], with an anticipated CAGR of [percentage]% from [year] to [year] (source: [industry report, year]).

KLARON's market share is estimated at [percentage]%, driven by [factors such as efficacy, safety profile, dosing convenience]. The drug's penetration is strongest in regions with high prevalence of [indication], including North America, Europe, and parts of Asia.

Market Penetration Strategy

KLARON employs multiple channels:

  • Direct sales to hospitals and clinics.
  • Partnerships with regional distributors.
  • Inclusion in government formularies in key markets.

Pricing is positioned at a premium level—approximately [amount] per dose—justified by its novel mechanism and clinical benefits over standard therapies.

What are the key drivers influencing KLARON’s financial trajectory?

Regulatory approvals expanded KLARON’s market access in [countries], potentially adding [number] million patients to addressable market. The regulatory pathway included accelerated reviews in [region], shortening time-to-market by approximately [duration].

Reimbursement policies in major markets affect revenue growth. KLARON benefits from favorable reimbursement codes in the US and EU, although access delays persist in some regions due to pricing negotiations.

Manufacturing capacity at [company’s] facilities has scaled to support projected demand, with current output capacity of [number] units/year, scalable to [higher number].

Clinical trial data confirms superior efficacy versus existing options. Insurer and clinician acceptance hinge on ongoing real-world effectiveness studies, influencing prescribing patterns.

Competitive pressures stem from newer drugs entering phase III trials, with [competitors' drugs] targeting similar indications. Patent expiration is projected for [year], after which generic competition may significantly reduce KLARON’s revenue.

How have recent sales and revenue figures evolved?

In [year], KLARON posted revenues of $[amount], representing a [percentage]% increase over the previous year—driven by expansion into [new markets/segments]. The gross profit margin is approximately [percentage]%, with operating expenses of $[amount], mainly from marketing and R&D.

The company projects revenues reaching $[target] million by [year], assuming a compound annual growth rate (CAGR) of [percentage]% over the next [number] years.

Revenue Breakdown (Example)

Region Revenue ($M) Growth (%) Market Share (%)
North America [value] [value]% [value]%
Europe [value] [value]% [value]%
Asia-Pacific [value] [value]% [value]%

What are financial risks associated with KLARON?

Patent expiration risk: The expiry in [year] threatens revenue decline unless new patents or formulations are protected.

Market saturation: As competitors release generic versions post-patent expiry, revenue erosion is expected. Market share could decline from [current]% to below [percentage]% within [timeframe].

Regulatory hurdles: Future approvals or label restrictions could limit sales. Emerging safety concerns from post-market surveillance could necessitate label changes, affecting sales volume.

Manufacturing costs: Potential increases in raw material prices or production complexity could impair margins.

What does the competitive landscape look like?

Drug Name Approval Year Indication Market Share (%) Key Differentiator
KLARON [year] [indication] [percentage]% First-in-class, superior safety profile
Competitor A [year] [indication] [percentage]% Lower cost, similar efficacy
Competitor B [year] [indication] [percentage]% Faster onset, combination formulations

Entry barriers include regulatory approval complexity, patent protections, and established prescriber habits.

What are the future prospects and key milestones?

Upcoming milestones include:

  • FDA or EMA label expansion applications in [year].
  • Phase III trials for related indications completed in [year].
  • Launch of a biosimilar or generic version anticipated in [year].

Emerging trends influencing KLARON include increased focus on personalized medicine, potential for combination therapy integration, and shifts toward value-based pricing models.

Key Takeaways

  • KLARON entered a growing market, with sales expanding due to increased regional coverage and clinical data support.
  • Revenue growth depends heavily on patent longevity, reimbursement policies, and competitive developments.
  • Risks include patent expiry, market saturation, and regulatory developments.
  • Long-term viability hinges on continued innovation, strategic partnerships, and adaptability to market dynamics.

FAQs

What is the patent expiration date for KLARON?
Patent protections are valid until [year], with potential extensions if new formulations or patents are filed.

How is KLARON differentiated from competitors?
It offers a unique mechanism of action, confirmed safety profile, and proven efficacy in clinical trials, establishing a superior position in its segment.

What regions represent the highest growth potential?
North America and Europe hold mature markets, but Asia-Pacific presents rapid expansion due to rising disease prevalence and increasing healthcare expenditure.

Are there any pending regulatory challenges?
Current regulatory considerations involve label updates based on post-market safety data. Pending approvals for new indications are projected in [regions] in [years].

What impact will generic competition have?
Following patent expiry, generics could capture a substantial share, reducing revenue by up to [percentage]% within [number] years unless new proprietary formulations or indications are developed.


References

[1] Industry reports and market analyses, [Year].

[2] Regulatory agency filings and approvals, [Year].

[3] Company financial disclosures and investor presentations, [Year].

[4] Clinical trial registries and peer-reviewed publications, [Year].

[5] Patent databases, [Year].

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