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Last Updated: December 22, 2024

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. Thirteen 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 SANDOZ on October 18th, 1988.

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Summary for KLARON
Drug patent expirations by year for KLARON
Drug Prices for KLARON

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

KLARON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Klaron (Sodium Sulfacetamide Lotion)

Introduction to Klaron

Klaron, a lotion containing sodium sulfacetamide, is an antibacterial agent used in the topical treatment of various skin conditions, including acne vulgaris, dandruff, seborrheic dermatitis, and certain skin infections[1][4].

Market Positioning

Therapeutic Use

Klaron is positioned within the dermatology segment of the pharmaceutical market, specifically targeting conditions that require localized antibacterial treatment. Its use is indicated for acne vulgaris, among other skin conditions, making it a part of the broader topical drug delivery market[1][4].

Market Dynamics

Growing Demand for Topical Treatments

The global topical drug delivery market, which includes products like Klaron, is expected to grow at a CAGR of 6.3% from 2024 to 2031. This growth is driven by increasing incidences of skin diseases such as psoriasis, eczema, and skin infections, as well as a rising preference for non-invasive treatment methods[3].

Technological Advancements

Continuous innovations in drug formulations and delivery technologies are enhancing the efficacy and convenience of topical treatments. This trend is likely to benefit products like Klaron, as pharmaceutical companies invest in improving delivery mechanisms[3].

Regulatory Landscape

The regulatory environment for topical drug delivery systems is stringent, with a focus on safety and efficacy. While this can pose challenges for new product approvals, established products like Klaron must comply with these regulations to maintain market presence. Regulatory obstacles can sometimes delay commercialization, but they also ensure high standards of safety and efficacy[3].

Competitive Pressure

The topical drug delivery market faces competition from alternative drug delivery systems, including oral, injectable, and transdermal methods. However, the convenience and localized action of topical treatments like Klaron continue to make them a preferred choice for many patients[3].

Financial Trajectory

Revenue and Market Size

While specific financial data for Klaron is not readily available, the broader topical drug delivery market provides context. The global market was valued at USD 109.16 billion in 2024 and is projected to reach USD 177.97 billion by 2031. This growth indicates a robust financial trajectory for products within this segment[3].

Research and Development

Pharmaceutical companies, including those that produce Klaron, invest significantly in research and development to improve existing products and develop new ones. For example, companies like Cocrystal Pharma, though not directly associated with Klaron, illustrate the trend of increased R&D expenses in the pharmaceutical sector, which can impact the financial performance of companies producing topical treatments[2].

Cost and Pricing

The cost of Klaron and similar topical treatments can vary based on factors such as formulation, brand, and geographical location. However, the overall trend in the market suggests that patients are willing to pay for effective and convenient topical treatments, supporting a stable financial trajectory for these products[3].

Safety and Efficacy Considerations

Side Effects and Contraindications

Klaron, like other sulfonamides, carries the risk of severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These risks are critical for both patients and manufacturers, as they can impact market perception and regulatory compliance[1][4].

Pharmacokinetics

Studies on the pharmacokinetics of Klaron have shown that the lotion is absorbed and excreted in small amounts, with the percentage of the applied dose excreted in the urine ranging from 0.08 to 0.33%. This data is crucial for understanding the safety profile and efficacy of the product[1][4].

Pregnancy and Reproduction Considerations

Klaron's use in pregnant women is cautious due to the lack of adequate and well-controlled studies. It is recommended to use Klaron in pregnant women only if clearly needed, highlighting the need for careful prescribing practices[1][4].

Key Takeaways

  • Klaron is part of a growing topical drug delivery market driven by increasing skin disease incidence and a preference for non-invasive treatments.
  • The market is influenced by technological advancements, regulatory requirements, and competitive pressures.
  • Financial performance is supported by a large and growing market, though specific data for Klaron is not available.
  • Safety and efficacy considerations, including potential side effects and contraindications, are crucial for market positioning.

FAQs

What is Klaron used for?

Klaron is used in the topical treatment of acne vulgaris, dandruff, seborrheic dermatitis, and certain skin infections[1][4].

What are the potential side effects of Klaron?

Klaron can cause severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other potential side effects include skin rash and other hypersensitivity reactions[1][4].

Can Klaron be used during pregnancy?

Klaron should be used in pregnant women only if clearly needed, due to the lack of adequate and well-controlled studies on its safety during pregnancy[1][4].

How does the topical drug delivery market impact Klaron?

The growing demand for localized treatment options and technological advancements in drug formulations support the market for products like Klaron, contributing to its financial trajectory[3].

What are the regulatory challenges for Klaron?

Klaron and other topical drug delivery systems must comply with stringent regulatory requirements focusing on safety and efficacy, which can sometimes delay commercialization but ensure high standards[3].

Cited Sources:

  1. RxList: Klaron (Sodium Sulfacetamide Lotion): Side Effects, Uses ...
  2. Cocrystal Pharma: Cocrystal Pharma Reports Second Quarter 2024 Financial Results ...
  3. GlobeNewswire: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 ...
  4. Drugs.com: Klaron: Package Insert / Prescribing Information - Drugs.com

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