STREPTOMYCIN SULFATE - Generic Drug Details

What are the generic sources for streptomycin sulfate and what is the scope of patent protection?

Streptomycin sulfate is the generic ingredient in one branded drug marketed by Copanos, Lilly, Pfizer, and Xgen Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for streptomycin sulfate. One supplier is listed for this compound.

Summary for STREPTOMYCIN SULFATE

US Patents:	0
Tradenames:	1
Applicants:	4
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,376
Drug Prices:	Drug price trends for STREPTOMYCIN SULFATE
DailyMed Link:	STREPTOMYCIN SULFATE at DailyMed

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Recent Clinical Trials for STREPTOMYCIN SULFATE

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	N/A

See all STREPTOMYCIN SULFATE clinical trials

Pharmacology for STREPTOMYCIN SULFATE

Drug Class

Aminoglycoside Antibacterial Antimycobacterial

Medical Subject Heading (MeSH) Categories for STREPTOMYCIN SULFATE

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for STREPTOMYCIN SULFATE

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01GA	Streptomycins
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for STREPTOMYCIN SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060111-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060107-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060404-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Copanos	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060684-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060107-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Streptomycin Sulfate

Last updated: July 28, 2025

Introduction

Streptomycin sulfate, an aminoglycoside antibiotic discovered in the 1940s, remains an important component of the antimicrobial arsenal. Despite the advent of newer agents, its clinical utility endures, driven by specific indications such as drug-resistant tuberculosis, plague, and certain bacterial infections. This article analyses current market dynamics, growth drivers, challenges, and the financial prospects for streptomycin sulfate, emphasizing strategic considerations for stakeholders.

Historical Context and Therapeutic Profile

Developed by Selman Waksman and colleagues, streptomycin catalyzed the antibiotic revolution, especially in tuberculosis (TB) management. Its mechanism involves binding to bacterial 30S ribosomal subunits, inhibiting protein synthesis. While newer drugs have supplanted streptomycin in many settings, it retains a niche role, particularly in MDR-TB, due to its efficacy and cost-effectiveness.

Current Market Landscape

Global Market Size and Segmentation

The global streptomycin sulfate market is modest relative to broader antibiotics, estimated at approximately USD 50-70 million in 2022[^1]. This figure accounts for manufacturing, procurement, and clinical use across various regions. The pharmaceutical supply chain primarily involves generic producers and government procurement programs, especially in low- to middle-income countries (LMICs).

Key Geographic Markets

• Asia-Pacific: Dominates due to high TB burdens, with India, China, and Southeast Asian nations sourcing significant quantities.
• Africa: Notably in regions with infectious disease outbreaks, particularly plague and MDR-TB.
• Europe and North America: Use is limited; primarily in laboratory settings or niche clinical cases, with zero or minimal production.

Supply Chain and Manufacturing

Streptomycin sulfate's synthesis involves fermentation processes with Streptomyces griseus. The generic manufacturing landscape is fragmented, with several companies producing sterile powders for injection. Patent protections have long expired, reinforcing generic penetration[^2].

Market Dynamics Influencers

Demand Drivers

• Tuberculosis Management: Streptomycin remains essential in MDR-TB treatment protocols, especially in combination with other first-line drugs, per WHO guidelines[^3].
• Infectious Disease Outbreaks: Outbreaks of plague and tularemia sustain demand in endemic regions.
• Cost Constraints: In resource-limited settings, its low cost and proven efficacy boost utilization over costly alternatives.

Regulatory Environment

Regulatory approval for streptomycin sulfate is governed by national authorities, with many countries relying on WHO prequalification status to ensure quality. Stringent regulations may hinder new entry into certain markets but pose minimal barriers to generics, as patents are expired.

Technological and Clinical Advancements

• Emerging Resistance: Growing resistance to streptomycin in TB strains has led to decreased empirical use in some settings[^4].
• Newer Antibiotics: The introduction of linezolid, bedaquiline, and other agents offers alternatives for resistant infections but often at higher costs, limiting their use in LMICs that continue to depend on streptomycin.

Pricing and Reimbursement Policies

Reimbursement remains limited in high-income countries, where clinical use is minimal. Conversely, in LMICs, procurement primarily follows government-negotiated prices, often subsidized by international agencies.

Competitive Landscape

The market is highly fragmented, with key players such as Gland Pharmaceutical (India), Hainan Lianhui Pharmaceutical (China), and several local manufacturers. The entry barrier is low due to expired patents and straightforward manufacturing, leading to intense price competition.

Challenges Impacting Market Growth

• Resistance Development: The rise of streptomycin-resistant TB strains reduces its relevance[^4].
• Limited Innovation: Absence of new formulations or delivery methods hampers growth potential.
• Regulatory Shifts: Strict quality standards may impose costs on manufacturers, potentially limiting supply.
• Preference for Newer Agents: Clinicians may prefer newer, more convenient drugs with fewer side effects where available.

Financial Trajectory and Future Outlook

Short-term Perspective (1-3 Years)

The market is expected to remain stable, primarily driven by ongoing TB programs in endemic regions. Price sensitivity and procurement policies will continue to influence volumes.

Medium to Long-term Outlook (4-10 Years)

• Modest Growth Potential: Anticipated annual growth rate remains modest at 1-2%, fueled by sustained demand in LMICs.
• Market Consolidation: Potential consolidation among generic manufacturers may stabilize prices.
• Resistance Challenges: Increasing resistance may lead to declining usage in some regions unless new combination therapies or formulations are developed.

Opportunities for Stakeholders

• Development of Fixed-Dose Combinations (FDCs): Combining streptomycin with other anti-TB drugs can improve compliance and marketability.
• Enhanced Manufacturing Processes: Cost reduction via biosynthesis improvements may bolster competitiveness.
• Targeted Use in Outbreaks: Strategic stockpiling and distribution during outbreaks of plague or tularemia.

Strategic Considerations

Stakeholders should monitor resistance trends and WHO updates, align procurement with global health initiatives, and explore innovative delivery systems (e.g., sustained-release formulations) to extend viability. Collaborations with international agencies, such as the Global Fund and WHO, can facilitate access and support market stability.

Key Takeaways

• Niche but Stable: Streptomycin sulfate remains essential in specific infectious disease treatments, notably MDR-TB, especially within resource-constrained settings.
• Market Size Constraints: The overall market remains modest, with limited growth prospects due to resistance and competition from newer antibiotics.
• Cost Advantage: Its low production costs and generic status sustain demand in LMICs, making it a critical component of global health strategies.
• Resistance as a Double-Edged Sword: Rising resistance diminishes its efficacy, pressing the need for ongoing surveillance and alternative therapies.
• Innovation and Policy: Development of formulations and strategic market positioning, aligned with international health initiatives, can bolster financial and clinical relevance.

FAQs

1. What is the current global demand for streptomycin sulfate?
   Annual global demand is estimated at USD 50-70 million, primarily driven by TB treatment programs in high-burden countries like India and China.

2. How does antibiotic resistance impact the future of streptomycin markets?
   Increasing resistance, especially in MDR-TB strains, reduces clinical use, potentially causing market contraction unless new combination therapies are introduced.

3. Are there major patent or regulatory barriers to entry for manufacturers?
   No; patents have expired, and regulatory pathways are well-established, especially for generic producers.

4. What are the main challenges facing streptomycin sulfate market growth?
   Resistance development, competition from newer antibiotics, limited innovation, and regulatory compliance costs.

5. Can newer formulations extend streptomycin's market longevity?
   Yes; sustained-release formulations or combination therapies could improve adherence, reduce resistance, and sustain clinical interest.

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References

[^1]: Market Research Future. (2022). Global Antibiotics Market.
[^2]: WHO. (2018). Guidelines for Treatment of Drug-Resistant Tuberculosis.
[^3]: World Health Organization. (2020). Global Tuberculosis Report.
[^4]: Wilson, D. P., & Stoeckle, S. (2021). "Antibiotic Resistance in Mycobacterium tuberculosis," Lancet Infectious Diseases.