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Last Updated: March 26, 2026

SODIUM SULFACETAMIDE Drug Patent Profile


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Which patents cover Sodium Sulfacetamide, and when can generic versions of Sodium Sulfacetamide launch?

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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Summary for SODIUM SULFACETAMIDE
Drug patent expirations by year for SODIUM SULFACETAMIDE
Drug Prices for SODIUM SULFACETAMIDE

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Recent Clinical Trials for SODIUM SULFACETAMIDE

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

SponsorPhase
Chang Gung Memorial HospitalPhase 1/Phase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityN/A

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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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084147-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sola Barnes Hind SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 084143-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc SODIUM SULFACETAMIDE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 083021-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

SODIUM SULFACETAMIDE Market Analysis and Financial Projection

Last updated: February 8, 2026

What are the market dynamics for Sodium Sulfacetamide?

Sodium Sulfacetamide is a topical sulfonamide antibiotic primarily used for treating bacterial infections, including rosacea, seborrheic dermatitis, and certain ocular infections. Its market factors are shaped by regulatory approvals, prescribing trends, and the competitive landscape.

Market Drivers

  • Prevalence of Skin Conditions: Increasing incidence of rosacea and seborrheic dermatitis elevates demand.
  • Advancements in Formulations: Introduction of combination therapies enhances treatment options.
  • Generic Availability: As off-patent formulations, lower prices boost accessibility, scaling volume sales.

Market Restraints

  • Limited Indications: Restricted approved uses limit market size.
  • Competitive Alternatives: Other antibiotics, including metronidazole and doxycycline, offer alternative treatments.
  • Side Effect Profile: Potential for allergic reactions and local irritation affects patient compliance.

Regulatory and Reimbursement Environment

  • FDA approval in the U.S. has been established for specific indications, including ophthalmic infections.
  • Reimbursement policies tend to favor established topical antibiotics, maintaining consistent access but limiting market expansion for new formulations.

Market Size and Growth

  • The global dermatological antibiotic market, including Sodium Sulfacetamide, was valued at approximately $600 million in 2022.
  • Compound annual growth rate (CAGR) from 2023 to 2028 is projected at 3-4%, driven by aging populations and rising skin condition prevalence.

Competitive Landscape

  • The market comprises brand-name products, such as Prontosil, and generics.
  • Major pharmaceutical companies maintain a presence through manufacturing rights, with some generic producers dominating.

What is the financial trajectory for Sodium Sulfacetamide?

Financial analysis depends on production costs, market penetration, pricing strategies, and competitive pressures.

Revenue Projections

  • Assuming broad adoption in dermatology and ophthalmology, revenues for a typical formulation can range from $50 million to $150 million annually in mature markets.
  • Growth depends on expansion into emerging markets, where healthcare access expands.

Cost Structure

  • Research and development costs are minimal for generic formulations, mainly associated with manufacturing scale and quality control.
  • Marketing expenses focus on physician education and product awareness, especially for newer formulations.

Profitability

  • Margins for generic drugs like Sodium Sulfacetamide are typically 20-30%, constrained by pricing pressures.
  • Brand-name products can sustain margins above 40% with patent protections and unique formulations.

Regulatory Impact

  • New approvals for additional indications could create revenue spikes.
  • Loss of exclusivity or patent expiry can lead to revenue decline, often by 50% or more over 2-3 years.

Market Risks

  • Emerging competitor entries and generics' price erosion threaten profit margins.
  • Changes in treatment guidelines or safety profiles could impact market share.

How do market dynamics influence long-term financial prospects?

Sodium Sulfacetamide's long-term financial outlook aligns with dermatological and ophthalmic healthcare trends. The aging global population and rising skin disease rates support steady demand. However, market share stability hinges on regulatory changes, competition, and efficacy perception.

Key financial considerations:

Factor Impact
Patent expiration Revenue declines without new formulations or indications
Entry of generics Price erosion compression profit margins
New formulations Potential for growth if approval expands use or improves compliance
Regulatory environment Approvals or restrictions influence access and reimbursement

What are the strategic implications for stakeholders?

Pharmaceutical companies must focus on optimizing manufacturing efficiency, expanding indications, and entering emerging markets to sustain revenue. Strategic partnerships or licensing can facilitate access to new formulations and minimize R&D costs.

Final analysis

The universe of Sodium Sulfacetamide remains stable in mature markets with limited growth potential. Margins are under pressure due to generic competition and pricing constraints. Opportunities exist through formulating new indications and expanding geographic reach.


Key Takeaways

  • Sodium Sulfacetamide is a niche antibiotic with steady but modest market growth.
  • Revenue prospects depend on market expansion, regulatory approvals, and competition management.
  • Generic entry pressures constrain profitability; innovation and geographic expansion are key strategies.
  • Market size is approximately $600 million globally, with a slow CAGR of 3-4% expected through 2028.
  • Long-term success hinges on product differentiation, regulatory navigation, and optimization of supply chain efficiencies.

FAQs

1. What conditions is Sodium Sulfacetamide primarily used to treat?
It treats bacterial skin infections such as rosacea, seborrheic dermatitis, and ocular infections.

2. How does patent status affect market potential?
Patent expirations lead to generic competition, reducing prices and profit margins.

3. Are there new formulations or indications under development?
Limited data indicate some interest in combination therapies or off-label uses, but regulatory approvals are sparse.

4. What are the primary competitors?
Other topical antibiotics like metronidazole and doxycycline dominate alternative treatment options.

5. Which regions hold the most growth opportunity?
Emerging markets, including Asia-Pacific and Latin America, exhibit expanding healthcare infrastructure and increasing skin condition prevalence.


References

[1] MarketWatch, “Dermatological Antibiotics Market Size, Share & Trends,” 2022.
[2] IQVIA, “Global Dermatology Market Report,” 2022.
[3] U.S. Food & Drug Administration, “Approved Ophthalmic Products,” 2023.

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