STREPTOMYCIN SULFATE Drug Patent Profile

Which patents cover Streptomycin Sulfate, and when can generic versions of Streptomycin Sulfate launch?

Streptomycin Sulfate is a drug marketed by Copanos, Lilly, Pfizer, and Xgen Pharms. and is included in six NDAs.

The generic ingredient in STREPTOMYCIN SULFATE is streptomycin sulfate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the streptomycin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Streptomycin Sulfate

A generic version of STREPTOMYCIN SULFATE was approved as streptomycin sulfate by XGEN PHARMS on June 30^th, 1998.

Summary for STREPTOMYCIN SULFATE

US Patents:	0
Applicants:	4
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	703
Drug Prices:	Drug price information for STREPTOMYCIN SULFATE
DailyMed Link:	STREPTOMYCIN SULFATE at DailyMed

See drug prices for STREPTOMYCIN SULFATE

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
Copanos	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060684-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	060076-002	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
Xgen Pharms	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	064210-001	Jun 30, 1998		RX	No	Yes
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

Market Dynamics and Financial Trajectory of Streptomycin Sulfate

Last updated: February 14, 2026

Overview
Streptomycin sulfate, an aminoglycoside antibiotic, was discovered in 1943 and gained FDA approval in 1947. Its primary indications include multidrug-resistant tuberculosis, plague, and certain bacterial infections. While its use has declined with the advent of newer antibiotics, it remains relevant in specific settings.

Market Size and Growth Trends
Global demand for streptomycin sulfate has experienced a decline post-2010 due to emerging resistance and the introduction of more effective antimicrobials. Estimated global sales in 2022 ranged between $50 million and $70 million, compared to peak sales exceeding $250 million in the 1970s[1].

• Regional Breakdown:

  • North America accounts for roughly 30% of current sales, driven by tuberculosis treatment protocols and resistant infections.
  • Europe represents about 25%, with declining use similar to North America.
  • Asia-Pacific region, especially India and China, constitutes roughly 35%, where streptomycin remains a part of multidrug-resistant TB treatment programs due to cost considerations and existing protocols.
  • Rest of the world contributes approximately 10%.

• Growth Factors:

  • Emerging markets' reliance on older antibiotics for tuberculosis management sustains demand.
  • Presence in niche applications prevents complete obsolescence.
  • Resistance development to newer drugs can periodically restore some demand.

Competitive Landscape
The market is dominated by generic pharmaceutical companies, with major players including Pfizer, Sanofi, and Indian firms such as Hetero Labs and Sun Pharmaceutical Industries. The rise of generic manufacturing has significantly reduced prices, with a typical wholesale cost between $0.50 to $2 per 1g dose[2].

• Pricing Trends:

  • Global price points have decreased approximately 40% over the past decade.
  • In low-income regions, prices remain stable due to procurement policies and subsidies.

• Patent Status:

  • No active patents since the 1970s, facilitating generic proliferation.

Regulatory Factors and Supply Chain
Regulatory agencies such as the FDA and EMA regulate manufacturing standards, with most pharmaceutical-grade streptomycin sulfate produced under Good Manufacturing Practices (GMP). Concerns over antibiotic residuals and manufacturing standards directly impact market access.

Supply chain disruptions occasionally occur due to geopolitical issues or manufacturing shortages, but routine provision is steady owing to multiple suppliers.

Financial Outlook and Investment Considerations
Future sales trajectory depends heavily on tuberculosis epidemiology, resistance patterns, and healthcare policies.

• Forecast (2023–2028):

  • The compound annual growth rate (CAGR) for streptomycin sulfate is projected to be around -2% to -3%, reflecting declining use but stable demand in niche markets.
  • Revenue stability may be maintained through bulk procurement by global health agencies like WHO, which prioritizes cost-effective treatments.

• Investment Risks:

  • Resistance emergence limits long-term utility.
  • Competition from newer antibiotics and combination therapies reduces market share.
  • Emphasis on antibiotic stewardship policies could further restrict use.

Key Drivers and Constraints	Drivers	Constraints
Use in multidrug-resistant TB in developing countries	Rising antibiotic resistance diminishes efficacy
Cost-effective alternative for resource-limited settings	Availability of newer antibiotics with broader spectrum
Continued regulatory approvals in select markets	Stringent regulations and quality compliance costs

Conclusion
Streptomycin sulfate remains a niche antibiotic with a steady, but diminishing, market. Its future depends on global TB control strategies, resistance patterns, and the evolution of treatment guidelines.

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Key Takeaways

• Global sales declined from over $250 million in the 1970s to under $70 million in 2022.
• The Asia-Pacific region now accounts for the majority of usage, driven mainly by TB treatment needs in India and China.
• The market is highly commoditized, with prices falling due to generic competition.
• Its use persists mainly in resistant tuberculosis cases and specific bacterial infections.
• Long-term growth prospects are limited, with a slow decline projected over the next five years.

FAQs

1. What clinical conditions primarily drive streptomycin sulfate use today?
   Multidrug-resistant tuberculosis, plague, and certain bacterial infections resistant to other antibiotics.

2. Who are the main manufacturers of streptomycin sulfate?
   Generic producers like Hetero Labs, Sun Pharmaceutical Industries, and several East Asian companies.

3. What factors influence the declining sales of streptomycin sulfate?
   Resistance to the drug, competition from newer antibiotics, regulation, and global antimicrobial stewardship initiatives.

4. Are there any recent regulatory changes affecting this drug?
   No major regulatory shifts recently; most updates relate to manufacturing quality standards.

5. What is the outlook for global sales in the next five years?
   Sales are expected to decline slowly, with an approximate CAGR of -2% to -3%.

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Sources
[1] GlobalData, 2022.
[2] IMS Health, 2022.