GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile

When do Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container launch?

Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, and Hospira. and is included in four NDAs.

The generic ingredient in GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is gentamicin sulfate. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

A generic version of GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as gentamicin sulfate by SANDOZ on December 31^st, 1969.

Summary for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
DailyMed Link:	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

Sponsor	Phase
Oslo University Hospital	Phase 1/Phase 2
University of California, San Diego	Phase 2
Kaiser Permanente	Phase 2

See all GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

Pharmacology for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Drug Class

Aminoglycoside Antibacterial

US Patents and Regulatory Information for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062414-009	Aug 15, 1983		DISCN	No	No
Hospira	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062588-004	Jan 6, 1986		DISCN	No	No
Hospira	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062588-002	Jan 6, 1986		DISCN	No	No

Market Dynamics and Financial Trajectory for Gentamicin Sulfate in Sodium Chloride 0.9% in Plastic Container

Last updated: March 1, 2026

What Is the Current Market Size and Growth Potential?

The global market for injectable antibiotics, including gentamicin sulfate, is expanding. In 2021, the antibiotics market was valued at approximately USD 45 billion, with injectable formulations representing around 35% of this segment. Gentamicin sulfate, as a widely used aminoglycoside, accounts for roughly 10-15% of injectable antibiotics globally, driven by hospital settings, particularly in developing regions.

Growth projections indicate an annual compound growth rate (CAGR) of approximately 4-6% over the next five years. Demand is driven by the increasing prevalence of bacterial infections, hospital-acquired infections, and the rising burden of infectious diseases requiring parenteral antibiotic therapy.

What Are the Key Drivers and Constraints?

Drivers:

• Rising Infectious Disease Incidence: An increase in bacterial infections, especially in ICU and immunocompromised patients, sustains demand.
• Healthcare Infrastructure Expansion: Developing markets expanding hospital capacity supports increased antibiotic use.
• Generic Market Penetration: Many formulations of gentamicin sulfate are off-patent, resulting in commoditized, lower-cost options.

Constraints:

• Antibiotic Resistance: Growing resistance diminishes clinical utility and shifts prescribing patterns.
• Regulatory Policies: Stricter approval and quality standards for sterile injectable drugs limit market entry.
• Pricing Pressures: Governments and healthcare providers seek lower-cost generics, reducing profit margins.

Which Market Segments and Geographies Are Most Significant?

Segments:

• Hospital Use: The primary segment, accounting for about 70% of sales, uses gentamicin sulfate for serious infections.
• Compounding Pharmacies: Smaller but growing sector, especially in regions with limited commercial supplies.
• Long-Term Care Facilities: Used for bacterial infections, but less predominant.

Key Geographies:

• North America: Largest market; growth driven by respiratory, urinary, and bloodstream infections.
• Europe: Mature market with high generic penetration; growth mainly in Eastern Europe.
• Asia-Pacific: Fastest growth rate, associated with increasing hospital capacity and infectious disease burden.

What Is the Financial Trajectory for Manufacturers?

Revenue Forecast:

Year	Estimated Global Revenue (USD Billion)	Growth Rate (%)
2022	0.8–1.2	—
2023	0.85–1.3	4–8
2025	1.0–1.6	4–7
2030	1.4–2.2	4–6

Most revenue will come from generic manufacturers in Asia-Pacific and North America. High-volume sales in hospital settings support low-margin, high-turnover business models.

Cost Structure and Profitability:

• Manufacturing Costs: Low due to high production volumes and mature manufacturing processes.
• Pricing Strategy: Dominated by generic suppliers offering competitive, often price-sensitive, products.
• Margins: Typically range from 10–15% for generic producers, variable by region and scale.

Investment Trends:

Manufacturers investing in quality assurance, sterilization, and supply chain resilience aim to meet regulatory standards and mitigate recalls. There is limited innovation opportunity, so focus remains on cost efficiency and market share expansion.

How Will Regulatory and Competitive Environments Evolve?

New regulations for sterile injectable manufacturing and quality control are increasing operating costs. Market entry barriers remain high, favoring established players. Competition intensifies in generic markets due to patent expirations.

Biotech entrants exploring novel aminoglycosides or targeted delivery methods could disrupt the traditional market, but adoption hurdles remain high.

What Are the Key Risks and Opportunities?

Risks:

• Resistance reducing clinical efficiency.
• Stringent regulations increasing compliance costs.
• Price erosion from aggressive generic competition.

Opportunities:

• Market expansion in underserved regions.
• Contract manufacturing for regional brands.
• Developing improved formulations with enhanced stability or reduced toxicity.

Final Outlook

The market for gentamicin sulfate in sodium chloride 0.9% in plastic containers will maintain steady growth, driven by global infectious disease trends and hospital utilization. Margins will remain compressed, with competition focused on cost control and supply reliability. Regulatory and resistance challenges persist, constraining innovation but reinforcing the importance of existing manufacturing expertise.

Key Takeaways

• The global injectable antibiotic market is growing at 4–6% annually, with gentamicin sulfate representing a significant portion.
• The primary revenue comes from hospital use, especially in North America, Europe, and Asia-Pacific.
• Generic manufacturers dominate, with price sensitivity and high-volume sales shaping profit margins.
• Regulatory changes and antibiotic resistance are the chief risks; regional expansion offers growth avenues.
• Investment focus should be on operational efficiency and supply chain resilience within a mature, commoditized segment.

FAQs

1. What is the main demand driver for gentamicin sulfate?
   The main driver is hospital treatment of bacterial infections, particularly in ICU and immunocompromised patients.

2. How does resistance impact the market?
   Rising resistance may reduce clinical usefulness, leading to decreased usage and impacting revenue.

3. Are there innovative formulations in development?
   Currently, most activity centers on generic manufacturing; novel formulations face regulatory and clinical adoption barriers.

4. Which regions are expanding fastest?
   Asia-Pacific exhibits the highest growth potential due to expanding healthcare infrastructure and infectious disease burden.

5. What are the typical profit margins for producers?
   Margins generally range from 10% to 15%, depending on scale, region, and competitive pressure.

References

[1] MarketsandMarkets. (2022). Antibiotics Market by Type, Route of Administration, and Region.
[2] GlobalData. (2022). Injectable Antibiotics Market Analysis.
[3] World Health Organization. (2021). Antimicrobial Resistance and Infectious Disease Management.
[4] Reuters. (2022). Generic drug market trends and pricing dynamics.
[5] FDA. (2022). Regulatory guidelines for sterile injectable drugs.[1]