Sulfadiazine - Generic Drug Details

What are the generic drug sources for sulfadiazine and what is the scope of patent protection?

Sulfadiazine is the generic ingredient in three branded drugs marketed by Abbvie, Chartwell Molecular, Epic Pharma Llc, Everylife, Impax Labs, Lederle, and Lilly, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for sulfadiazine. Two suppliers are listed for this compound.

Summary for sulfadiazine

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	30
Patent Applications:	6,885
Drug Prices:	Drug price trends for sulfadiazine
What excipients (inactive ingredients) are in sulfadiazine?	sulfadiazine excipients list
DailyMed Link:	sulfadiazine at DailyMed

See drug prices for sulfadiazine

Recent Clinical Trials for sulfadiazine

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

Sponsor	Phase
Dr Muhammad Naveed Shahzad	NA
Hospital San Pietro Fatebenefratelli	PHASE4
University of Cagliari	PHASE4

See all sulfadiazine clinical trials

Pharmacology for sulfadiazine

Drug Class

Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for sulfadiazine

Anti-Infective Agents

Antiprotozoal Agents

Coccidiostats

Anatomical Therapeutic Chemical (ATC) Classes for sulfadiazine

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for sulfadiazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	SULFADIAZINE SODIUM	sulfadiazine sodium	INJECTABLE;INJECTION	004054-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbvie	SULFADIAZINE	sulfadiazine	TABLET;ORAL	004125-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	SULFONAMIDES DUPLEX	sulfadiazine; sulfamerazine	SUSPENSION;ORAL	006317-007	Approved Prior to Jan 1, 1982		DISCN	No	No
Everylife	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080088-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	SULFADIAZINE	sulfadiazine	TABLET;ORAL	004054-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080081-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Chartwell Molecular	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080084-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Sulfadiazine

Last updated: February 16, 2026

Overview

Sulfadiazine is an antibacterial sulfonamide used primarily to treat infections caused by sensitive bacteria, including Toxoplasma gondii. Once a first-line treatment in specific infectious disease contexts, its market has declined with the advent of more effective and safer options. However, niche applications and emerging markets influence current and future valuation.

Market Size and Trends

The global antimicrobial drug market was valued at approximately $59 billion in 2022, with sulfonamides accounting for roughly 4%–6% of this figure in historical sales. Sulfadiazine's market share has diminished significantly over the past two decades, primarily due to safety concerns and competition from broad-spectrum antibiotics like trimethoprim-sulfamethoxazole, which offer better efficacy profiles and fewer adverse reactions.

Current markets for sulfadiazine are concentrated in:

• Developing Countries: where it retains use due to low cost and availability.
• Store-placed niche indications: including ocular infections, toxoplasmosis, and in combination therapies.

Regulatory and Patent Status

Sulfadiazine is off-patent globally. It remains available as a generic drug, with no major patent protections limiting competition. Regulatory approvals, especially in developed markets, are often limited to specific indications.

Manufacturing and Supply Dynamics

Manufacturing involves established synthetic routes with stable supply chains. Cost of production remains low due to generic availability. Supply chain vulnerabilities are minimal but could be affected in regions with political instability or regulatory shifts.

Pricing and Revenue Potential

Pricing varies mainly based on regional regulatory environments and healthcare systems. In low-income regions, generic sulfadiazine costs approximately $0.10–$0.50 per capsule. In higher-income settings, pricing increases slightly but remains within the low-dollar range, limiting revenue potential but ensuring steady demand.

Projected revenue for sulfadiazine remains modest:

• Estimated global sales: Less than $50 million annually.
• Growth prospects: Marginal, driven by increased use in niche indications and emerging markets.

Competitive Landscape

Sulfadiazine faces competition from:

• Trimethoprim-sulfamethoxazole
• Oral and topical antibiotics for ocular infections
• Antiparasitic agents for toxoplasmosis

The adoption rate of sulfadiazine decreases as newer agents provide improved safety profiles and dosing convenience.

Forecasting and Financial Trajectory

Given its patent status and market position, sulfadiazine’s revenue is expected to decline gradually. Key factors influencing future trajectory include:

• Adoption trends in toxoplasmosis and ocular infections
• Cost-effectiveness compared to newer agents
• Regulatory restrictions or approvals for specific indications
• Supply disruptions or price controls

Revenue projection over the next 5 years suggests a decline of approximately 2%–4% annually, barring regulatory or healthcare system shifts.

Emerging Opportunities

Limited potential exists in:

• Developing countries where low-cost generics dominate
• Niche indications like ocular infections or toxoplasmosis in immunocompromised patients

Research efforts or new formulations are unlikely due to the drug’s age and safety concerns.

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Key Takeaways

• Sulfadiazine’s market has shrunk significantly due to safety issues and competition.
• It maintains a stable, low-revenue niche in developing regions.
• No patent protections exist, with generics controlling supply.
• Revenue is forecasted to decline gradually amid limited growth prospects.
• The drug’s future depends on niche applications and regional market dynamics.

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FAQs

1. What factors have led to the decline in sulfadiazine sales?
   Safety concerns and the availability of more effective, safer antibiotics like trimethoprim-sulfamethoxazole reduce its clinical use and market size.

2. Can sulfadiazine expand into new indications?
   Limited potential exists due to longer-term safety issues, lack of patent protection, and minimal financial incentives for development.

3. How does the supply chain impact sulfadiazine’s market?
   Manufacturing is established with low-cost synthesis, minimizing supply risks. Market fluctuations are primarily regional regulatory or economic in nature.

4. What is the typical price per unit for sulfadiazine?
   In developing nations, approximately $0.10–$0.50 per capsule; in developed markets, slightly higher due to regulatory and distribution costs.

5. What are the primary competition channels?
   Competing antibiotics, especially combination drugs like trimethoprim-sulfamethoxazole, with broader safety and efficacy profiles.

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Citations

[1] "Global Antibiotics Market," MarketsandMarkets, 2022.
[2] "Sulfadiazine: Generic Drug Data," FDA Database, 2023.
[3] "Market Share of Sulfonamide Antibiotics," IMS Health, 2022.