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Last Updated: March 19, 2026

SODIUM SULFACETAMIDE Drug Patent Profile


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

Sodium Sulfacetamide is a drug marketed by Epic Pharma Llc and Sola Barnes Hind and is included in five NDAs.

The generic ingredient in SODIUM SULFACETAMIDE 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 Sodium Sulfacetamide

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

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  • What is the 5 year forecast for SODIUM SULFACETAMIDE?
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Summary for SODIUM SULFACETAMIDE
US Patents:0
Applicants:2
NDAs:5

US Patents and Regulatory Information for SODIUM SULFACETAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 083021-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084147-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084143-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 083021-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 083021-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084146-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084145-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Sodium Sulfacetamide: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Sodium sulfacetamide, a sulfonamide bacteriostatic antimicrobial agent primarily used to treat ocular, dermatological, and seborrheic conditions, remains an essential drug with a stable market. Its annual global sales are estimated to be approximately USD 100-150 million, with growth driven by dermatology and ophthalmology sectors. Despite generic dominance, emerging formulations and indications present investment opportunities, especially in markets with unmet needs.

Introduction

Sodium sulfacetamide’s primary indications include bacterial conjunctivitis, rosacea, seborrheic dermatitis, and acne vulgaris. It is marketed globally, with a significant share in OTC and prescription segments. The drug’s safety profile, cost-effectiveness, and versatility underpin its sustained demand.

Market dynamics are shaped by regulatory landscapes, patent expirations, competitive landscape, and evolving clinical practices. This analysis delineates the current market environment, growth drivers, financial trajectories, and investment considerations.


What Is the Current Market Size and Revenue for Sodium Sulfacetamide?

Parameter Details
Global Market Size (2022) USD 100-150 million (estimated)
Major Markets United States, Europe, Asia-Pacific
Market Growth Rate Compound Annual Growth Rate (CAGR): 2-4% (2018-2022)
Revenue Breakdown Dermatology (60%), Ophthalmology (30%), OTC products (10%)
Leading Manufacturers Alcon, Bausch + Lomb, Allergan, Santen, Generic firms
Patent Status Patent expirations for formulations dating back 2010s

Source: IMARC Group (2022); global pharmaceutical sales data, IQVIA.


What Are the Market Dynamics Affecting Sodium Sulfacetamide?

Regulatory Environment

Aspect Impact
Patent expirations Increased generic entries post-2010, intensifying price competition
Regulatory approvals Well-established, with minimum recent changes; recent approvals for novel formulations help growth
Reimbursement policies Reimbursement varies; higher in developed countries, limiting OTC expansion in some regions

Competitive Landscape

Competitors Market Share Strategies
Generic manufacturers ~70% Price competition, diversified formulations
Innovators/formulation developers ~30% Combination formulations, improved tolerability

Clinical and Market Drivers

Driver Impact
Rising prevalence of skin conditions Acne, rosacea, seborrheic dermatitis increases drug utilization
Growing ophthalmic conditions Conjunctivitis, dry eye-related diseases expand prescription volume
Preference for OTC products Increased OTC availability and self-medication trends
New formulations Liposomal, sustained-release, or combination products open niche markets

Emerging Trends

  • Development of combination drugs featuring sodium sulfacetamide with other actives (e.g., sulfur, benzoyl peroxide).
  • Advances in topical delivery systems improving skin penetration and compliance.
  • Expansion into developing markets with rising dermatology burdens.

What Is the Financial Trajectory of Sodium Sulfacetamide?

Revenue Forecasts

Year Estimated Global Revenue (USD millions) Notes
2023 120 Baseline estimate
2025 130-140 Slight growth, expansion into emerging markets
2030 150-180 Potential for novel formulations, broader indications

Profitability Considerations

Factor Impact
Price erosion Due to generic competition, margins may decline
Manufacturing costs Low due to mature synthesis processes
Formulation innovation Higher margins for differentiated or patent-protected products
Regulatory costs Minimal for established markets; higher for approvals of new formulations

Investment Opportunities

Segment Potential Rationale
Generic market expansion Stable income streams Low R&D costs, high volume sales
Innovative formulations High margins, patent protections Higher development costs, but better exclusivity
Emerging market expansion Growth opportunities Rising dermatology and eye health needs

How Do Competitive and Regulatory Factors Influence Financial Planning?

Factor Financial Implication
Patent cliff Earmark funds for development of new formulations
Regulatory hurdles Spend on compliance; affect product timelines
Market consolidation Potential for licensing deals or M&A activity
Pricing pressure Emphasize cost efficiency and volume sales

Comparison with Similar Drugs

Drug Class Key Characteristics Market Size (USD, 2022) Main Use Cases
Sulfonamides (e.g., sulfadiazine) Broad antibacterial activity, topical and systemic forms USD 300 million (approx.) Bacterial infections, eye infections
Benzoyl Peroxide Acne treatment, OTC, topical agent USD 100 million Acne
Metronidazole Topical and systemic, anti-inflammatory USD 200 million Skin infections, rosacea

Note: Vitamin to understanding the competitive landscape; not directly substitutes but related agents.


Key Investment Considerations

Aspect Strategic Implication
Patent expirations Increased generics but opportunity in formulation innovation
Regulatory environment Favorable with established safety profiles; focus on novel delivery systems
Market demand drivers Rising dermatology and ophthalmology treatment needs
Manufacturing scalability Cost-effective due to mature production processes
Market penetration in emerging economies High potential; expanding healthcare infrastructure supports growth

Conclusion: Financial Trajectory Outlook

Sodium sulfacetamide’s market is mature but not stagnant. Its stable demand, especially in dermatology and ophthalmology, positions it as a low-to-moderate risk investment opportunity. Key drivers include formulation innovations and expanding use cases. The competitive landscape favors margin growth through differentiated products, with emerging markets offering substantial growth prospects. The primary risks remain in pricing pressures and regulatory changes but can be mitigated with strategic R&D and market positioning.


Key Takeaways

  • The global sodium sulfacetamide market is valued at USD 100-150 million, with steady growth projections.
  • Increased demand is driven by dermatological conditions, ophthalmic indications, and OTC accessibility.
  • Current market dynamics favor generic manufacturers, but innovation and formulations offer higher-margin opportunities.
  • The financial trajectory suggests modest growth, with potential upsides from new formulations and expanding markets.
  • Strategic investments should prioritize novel delivery systems, combination therapies, and expansion into emerging economies.

FAQs

1. What are the primary indications for sodium sulfacetamide?
It is mainly used for bacterial conjunctivitis, rosacea, seborrheic dermatitis, and acne vulgaris.

2. How does patent expiration affect the market?
Patent expirations post-2010 have led to increased generic entry, intensifying price competition but also opening opportunities for formulation innovation.

3. What are the growth drivers for future revenue?
Key drivers include dermatological and ophthalmic disease prevalence, OTC demand, new formulations, and emerging market expansion.

4. What risks should investors consider?
Pricing pressures from generics, regulatory hurdles for new formulations, and market saturation pose risks, mitigated by innovation and geographic expansion.

5. How does sodium sulfacetamide compare with similar drugs?
Compared to other sulfonamides and acne treatments like benzoyl peroxide and metronidazole, sodium sulfacetamide benefits from established efficacy and safety but faces competition from newer agents.


References

[1] IMARC Group. (2022). Global dermatology market report.
[2] IQVIA. (2022). Pharmaceutical market insights.
[3] FDA. (2022). Summary of approved ophthalmic drugs.
[4] MarketWatch. (2022). Mergers and acquisitions in dermatology.

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