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Last Updated: January 3, 2025

SULFACEL-15 Drug Patent Profile


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When do Sulfacel-15 patents expire, and when can generic versions of Sulfacel-15 launch?

Sulfacel-15 is a drug marketed by Optopics and is included in one NDA.

The generic ingredient in SULFACEL-15 is sulfacetamide sodium. There are three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sulfacel-15

A generic version of SULFACEL-15 was approved as sulfacetamide sodium by SANDOZ on October 18th, 1988.

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Summary for SULFACEL-15
Drug patent expirations by year for SULFACEL-15

US Patents and Regulatory Information for SULFACEL-15

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Optopics SULFACEL-15 sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 080024-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

SULFACEL-15 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Sulfacetamide: A Deep Dive

Introduction

Sulfacetamide, a sulfonamide antibiotic, has been a staple in the treatment of various bacterial infections, particularly those affecting the skin and eyes. To understand its market dynamics and financial trajectory, it is crucial to delve into its uses, market performance, and the broader pharmaceutical industry trends.

Mechanism of Action and Uses

Sulfacetamide is known for its bacteriostatic actions, inhibiting the growth of most gram-positive and many gram-negative bacteria by acting as a competitive inhibitor of para-aminobenzoic acid (PABA) in the folic acid metabolism cycle[1].

Dermatological and Ophthalmic Applications

It is commonly used in dermatological preparations such as lotions, washes, and suspensions to treat acne, rosacea, and other skin infections. In ophthalmology, sulfacetamide is used in eye drops and solutions to treat conjunctivitis and other bacterial eye infections.

Market Performance

Revenue and Sales

The market performance of sulfacetamide products can be inferred from the broader pharmaceutical market trends. For instance, companies like Bausch Health, which produces various dermatological and ophthalmic products, have shown significant revenue growth. In the second quarter of 2023, Bausch Health reported total revenues of $2.17 billion, a 10% increase from the previous year, driven by strong performance in segments like the Bausch + Lomb segment, which includes ophthalmic products[2].

Segment-Specific Growth

While specific revenue figures for sulfacetamide products are not readily available, the growth in the ophthalmic and dermatological segments can indicate a positive trend. For example, the Bausch + Lomb segment, which includes eye care products, saw a 10% increase in revenue, reflecting a strong demand for ophthalmic treatments[2].

Competitive Landscape

Market Alternatives

The antibiotic market is highly competitive, with various alternatives available for treating bacterial infections. However, sulfacetamide's broad-spectrum activity and its specific use in dermatological and ophthalmic applications help it maintain a niche market position.

Resistance and Sensitivity

One of the challenges faced by sulfacetamide and other sulfonamides is the development of bacterial resistance. Resistance to one sulfonamide generally indicates resistance to all, which can impact market demand and necessitate the development of new antibiotics[1].

Financial Trajectory

Pricing and Availability

Sulfacetamide products are available in various formulations and prices. For example, Klaron 10% Lotion and Sulfacetamide-Sulfur Wash are priced differently based on their formulations and quantities, indicating a range of pricing strategies to cater to different market segments[1].

Revenue Projections

While specific financial projections for sulfacetamide are not available, the overall growth in the pharmaceutical industry, particularly in the ophthalmic and dermatological segments, suggests a stable to growing financial trajectory for these products.

Regulatory Environment

FDA Approvals and Compliance

Sulfacetamide products must comply with FDA regulations, and any changes in regulatory requirements can impact their market dynamics. For instance, the FDA's approval of new formulations and delivery systems, such as the approval of latanoprost ophthalmic emulsion without benzalkonium chloride, can influence market trends and consumer preferences[4].

Consumer and Prescriber Trends

Patient Preferences

Patients increasingly prefer treatments with fewer side effects and better tolerability. Sulfacetamide, while effective, can cause side effects such as erythema, edema, nausea, and dizziness, which may influence prescriber and patient preferences towards alternative treatments[1].

Prescriber Behavior

Prescribers often consider the efficacy, safety profile, and patient compliance when selecting treatments. The broad-spectrum activity of sulfacetamide makes it a viable option, but prescribers must also consider resistance patterns and patient-specific factors.

Future Outlook

Research and Development

The future outlook for sulfacetamide and similar antibiotics depends on ongoing research and development. Companies are continually working to improve formulations, reduce side effects, and combat antibiotic resistance. For example, advancements in delivery systems and the development of new antibiotics can impact the market dynamics of existing products like sulfacetamide.

Market Expansion

Expansion into new markets, particularly in regions with growing healthcare needs, can also drive the financial trajectory of sulfacetamide products. Companies like Bausch Health are focusing on international growth, which could benefit products like sulfacetamide[2].

Key Takeaways

  • Broad-Spectrum Activity: Sulfacetamide's effectiveness against a wide range of bacteria makes it a valuable treatment option.
  • Market Growth: The ophthalmic and dermatological segments are growing, indicating a positive market trend for sulfacetamide products.
  • Regulatory Compliance: Adherence to FDA regulations is crucial for the continued market presence of sulfacetamide products.
  • Consumer and Prescriber Trends: Patient preferences for treatments with fewer side effects and better tolerability can influence market dynamics.
  • Future Outlook: Ongoing research and development, along with market expansion, will shape the future financial trajectory of sulfacetamide.

FAQs

What is the mechanism of action of sulfacetamide?

Sulfacetamide acts as a competitive inhibitor of para-aminobenzoic acid (PABA) in the folic acid metabolism cycle, inhibiting bacterial growth.

What are the common uses of sulfacetamide?

Sulfacetamide is commonly used in dermatological and ophthalmic preparations to treat acne, rosacea, conjunctivitis, and other bacterial infections.

How does bacterial resistance affect sulfacetamide?

Resistance to one sulfonamide generally indicates resistance to all, which can reduce the effectiveness and market demand for sulfacetamide.

What are the side effects of sulfacetamide?

Common side effects include erythema, edema, nausea, vomiting, headache, dizziness, and tiredness.

How does the regulatory environment impact sulfacetamide products?

FDA approvals and compliance are crucial for the market presence of sulfacetamide products. Changes in regulatory requirements can influence market trends and consumer preferences.

Sources

  1. DrugBank: Sulfacetamide: Uses, Interactions, Mechanism of Action.
  2. Bausch Health: Second Quarter 2023 Results.
  3. Journal Of The American Pharmaceutical Association: Full text of "Journal Of The American Pharmaceutical Association(18)".
  4. Modern Optometry: Boost Your Glaucoma Drug Knowledge.

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