Gentamicin sulfate - Generic Drug Details

What are the generic sources for gentamicin sulfate and what is the scope of freedom to operate?

Gentamicin sulfate is the generic ingredient in twelve branded drugs marketed by Schering, Pharmafair, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Taro, King Pharms, Bristol, Intl Medication, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, B Braun, Baxter Hlthcare, Pharmacia And Upjohn, Novartis, Fera Pharms Llc, Sciegen Pharms Inc, Encube, Allergan, Renova Pharms, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Paco, and Sandoz, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for gentamicin sulfate. Twenty-four suppliers are listed for this compound.

Summary for gentamicin sulfate

US Patents:	0
Tradenames:	12
Applicants:	36
NDAs:	62
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	13
What excipients (inactive ingredients) are in gentamicin sulfate?	gentamicin sulfate excipients list
DailyMed Link:	gentamicin sulfate at DailyMed

See drug sales revenues for gentamicin sulfate

Recent Clinical Trials for gentamicin sulfate

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

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

See all gentamicin sulfate clinical trials

Pharmacology for gentamicin sulfate

Drug Class

Aminoglycoside Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for gentamicin sulfate

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for gentamicin sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062814-005	Aug 28, 1987		DISCN	No	No
Pharmacia And Upjohn	U-GENCIN	gentamicin sulfate	INJECTABLE;INJECTION	062248-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062413-009	Aug 11, 1983		DISCN	No	No
Abbott	GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062413-002	Aug 11, 1983		DISCN	No	No
Hospira	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062414-009	Aug 15, 1983		DISCN	No	No
Watson Labs	GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062318-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Gentamicin Sulfate

Last updated: July 27, 2025

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Introduction

Gentamicin sulfate, an aminoglycoside antibiotic discovered in the 1960s, remains a pivotal drug for treating severe bacterial infections, especially those caused by gram-negative organisms. Despite the proliferation of newer antibiotics, gentamicin sustains relevance owing to its broad-spectrum activity, cost-effectiveness, and well-established clinical applications. This article examines the underlying market dynamics and forecasts the financial trajectory of gentamicin sulfate, considering factors such as global demand, manufacturing landscape, competitive pressures, regulatory influences, and emerging therapeutic trends.

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Market Landscape and Key Drivers

Global Demand and Therapeutic Utilization

Gentamicin sulfate's primary market stems from hospital settings, especially intensive care units (ICUs), for infections like septicemia, pneumonia, and urinary tract infections. The growing prevalence of multidrug-resistant organisms underscores a continued reliance on aminoglycosides. According to the World Health Organization, bacterial infections with resistant strains have surged, emphasizing the importance of antibiotics like gentamicin [1].

The surge in healthcare infrastructure in emerging markets, notably Asia-Pacific, propels demand. Hospitals in China, India, and Southeast Asia increasingly incorporate gentamicin into treatment protocols due to its affordability and proven efficacy.

Antibiotic Stewardship and Resistance Trends

Antibiotic stewardship programs aim to optimize drug use and reduce resistance. While gentamicin's broad-spectrum activity is advantageous, resistance development poses challenges. Bacterial mechanisms such as aminoglycoside-modifying enzymes have decreased susceptibility rates, prompting cautious use and influencing demand patterns.

Manufacturing and Supply Chain Considerations

Major pharmaceutical manufacturers, predominantly in India and China, produce gentamicin sulfate, leveraging cost efficiencies. Patent expirations and generic manufacturing have promoted price competitiveness, facilitating broad distribution.

However, supply chain disruptions—exacerbated by global events such as the COVID-19 pandemic—have temporarily affected production and distribution. As manufacturing shifts towards more localized supply chains, regional market dynamics may evolve.

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Market Challenges and Competitive Landscape

Competitive Substitutes and Market Elimination

The pharmaceutical landscape features several alternatives—such as amikacin, tobramycin, and newer agents like plazomicin—that often offer improved safety profiles or resistance profiles. Consequently, gentamicin faces stiff competition, especially in settings where drug safety and resistance management are prioritized.

Regulatory Environment

Stringent regulatory requirements by agencies such as the U.S. FDA and EMA influence market access. Generic manufacturers benefit from patent expiries; however, variations in regional regulatory processes can create market entry barriers or delays.

Safety Concerns and Usage Limitations

Nephrotoxicity and ototoxicity associated with gentamicin restrict its use, particularly in chronic settings. These safety concerns influence prescriber preferences and affect sales volume, especially in markets with heightened emphasis on safety.

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Financial Trajectory and Market Forecasts

Revenue Trends and Market Size

The global generic antibiotics market, estimated to be valued at approximately USD 40 billion in 2022, exhibits a compound annual growth rate (CAGR) of about 4% to 6% over the next five years [2]. Gentamicin sulfate constitutes a significant portion of this segment due to its low-cost efficacy.

Market size estimates for gentamicin specifically hover around USD 200–300 million annually, with regional variations. Growth is primarily driven by rising infection rates, expanding healthcare access, and ongoing reliance on generics.

Growth Opportunities

Emerging markets present lucrative opportunities owing to unmet needs and price sensitivity. Additionally, applications in veterinary medicine—particularly in livestock—are expanding, contributing to revenue streams, although regulatory constraints differ from human pharmaceuticals.

Innovations in drug formulations—such as liposomal gentamicin—aim to reduce toxicity and improve delivery, potentially opening new revenue avenues, albeit with higher development costs.

Pricing and Cost Dynamics

The dominance of generics has created a highly competitive pricing landscape. Prices for gentamicin sulfate vials have declined by approximately 30–50% over the past decade. Although volume-driven, margins are thin, emphasizing the importance of manufacturing efficiencies and supply chain optimization.

Impact of Regulatory and Policy Changes

Policy shifts, such as subsidies for antimicrobial stewardship and antimicrobial resistance (AMR) initiatives, may influence market dynamics. Governments in certain regions are promoting the rational use of antibiotics, potentially curbing overprescription and affecting sales volumes.

In parallel, international efforts to combat AMR could lead to increased investments in new formulations, possibly reducing the reliance on traditional gentamicin sulfate.

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Emerging Trends and Future Directions

Innovation and Development

Research efforts focus on developing gentamicin formulations with improved safety profiles and targeted delivery systems. Liposomal gentamicin, for instance, offers promise in reducing toxicity while maintaining efficacy. Such innovations could command premium pricing and expand market share, especially in developed markets.

Drug Resistance Mitigation Strategies

Global health initiatives advocate for judicious use of antibiotics. As resistance patterns evolve, the role of gentamicin may shift, with increased usage in targeted infections or combination therapies to extend drug lifespan.

Market Consolidation

The competitive landscape is consolidating as larger pharma firms acquire smaller generic producers to optimize economies of scale and R&D capabilities. Such consolidation could impact pricing strategies and market access.

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Conclusion: The Financial Outlook

Gentamicin sulfate's market is characterized by steady demand driven by its cost-effectiveness and broad-spectrum activity, especially in regions with constrained healthcare budgets. While affordability ensures its continued relevance, challenges such as resistance, safety concerns, and competitive substitutes temper growth prospects.

The financial trajectory over the next five years suggests a modest CAGR of around 3% to 5%, contingent upon regional demand, regulatory developments, and technological innovations. Opportunities lie in developing safer formulations and expanding usage in veterinary and niche applications. However, sustained competition and stringent stewardship policies necessitate strategic positioning for market participants.

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Key Takeaways

• Steady Demand: Gentamicin sulfate remains integral to treating severe bacterial infections, especially in emerging markets, driven by affordability and efficacy.

• Competitive Pressures: The emergence of safer, more targeted antibiotics may limit growth, despite existing demand.

• Regulatory and Safety Constraints: Ongoing concerns around toxicity and resistance influence prescribing patterns and market access.

• Innovation as a Growth Driver: Developing formulations with improved safety profiles can unlock new revenue streams and expand market share.

• Market Outlook: Overall, gentamicin sulfate’s market is poised for gradual growth, with a focus on optimizing manufacturing, navigating regulatory landscapes, and improving drug safety.

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FAQs

1. What is the current global market size for gentamicin sulfate?
The annual global market for gentamicin sulfate is estimated between USD 200 million and USD 300 million, with the largest contributions from low-cost generic manufacturing in Asia.

2. How does antibiotic resistance impact gentamicin’s market?
Resistance mechanisms reduce gentamicin’s efficacy, necessitating careful stewardship and limiting unnecessary use, which can suppress certain market segments but also stimulate innovation.

3. What are the main competitors to gentamicin sulfate?
Competitors include aminoglycosides like amikacin and tobramycin, as well as newer antibiotics with better safety profiles, such as plazomicin, which may replace gentamicin in some indications.

4. Are there ongoing innovations that could influence gentamicin’s market?
Yes, formulations like liposomal gentamicin aim to reduce toxicity and improve delivery, potentially increasing usage and expanding markets.

5. What regional factors influence gentamicin sulfate’s market dynamics?
Emerging markets exhibit strong growth due to infection prevalence and cost sensitivity, whereas developed markets are more influenced by safety profiles and resistance concerns. Regulatory policies and antimicrobial stewardship programs also significantly impact adoption rates.

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Sources

[1] World Health Organization. (2021). Global antimicrobial resistance surveillance report.
[2] MarketsandMarkets. (2022). Antibiotics Market Report.