GENTAMICIN SULFATE - Generic Drug Details

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

Gentamicin sulfate is the generic ingredient in twelve branded drugs marketed by Schering, Pharmafair, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Sun Pharma Canada, 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, Pharmobedient, 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-three 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:	23
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
University of California, San Diego	Phase 2
Kaiser Permanente	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
Schering	GARAMYCIN	gentamicin sulfate	OINTMENT;TOPICAL	060463-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062414-010	Aug 15, 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

Market Dynamics and Financial Trajectory for Gentamicin Sulfate

Last updated: January 26, 2026

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Executive Summary

Gentamicin Sulfate, an aminoglycoside antibiotic, remains a critical therapeutic agent against serious bacterial infections. Although patent protections expired decades ago, its market landscape is influenced by antimicrobial resistance (AMR), regulatory policies, manufacturing costs, and evolving treatment protocols. The global gentamicin market was valued at approximately USD 100 million in 2022, with a projected compound annual growth rate (CAGR) of 3-4% through 2030. This growth is driven by increased demand in hospitals, emerging markets, and the shift towards combination therapies, despite rising concerns over AMR and alternatives perceived as safer.

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Market Size and Historical Trends

Year	Estimated Market Value (USD million)	CAGR (2018–2022)	Key Drivers
2018	85	—	Basic usage in ICU, surgical prophylaxis
2019	89	4.7%	Rising bacterial infections
2020	92	3.4%	COVID-19 pandemic increased demand
2021	96	4.3%	Enhanced hospital antimicrobial use
2022	100	4.2%	Expanding use in developing countries

Source: MarketResearch.com [1]

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Key Market Drivers

• Increasing Incidence of Bacterial Infections: The prevalence of healthcare-associated infections (HAIs) and multidrug-resistant bacteria sustains demand for aminoglycosides like gentamicin.

• Growing Use in Low- and Middle-Income Countries (LMICs): Limited access to newer antibiotics in emerging markets continues to stimulate gentamicin sales.

• Necessity in Combination Therapies: Clinicians often combine gentamicin with beta-lactams to combat severe infections, maintaining its role despite concerns over toxicity.

• Regulatory Approvals and Patent Status: No patents restrict manufacturing, lowering barriers for generic entry, which supports stable supply but constrains pricing.

Market Challenges

Challenge	Impact
Rising antimicrobial resistance	Diminished efficacy, leading to reduced use
Toxicity profile (nephrotoxicity, ototoxicity)	Limits broader application, especially in outpatient settings
Availability of newer, safer antibiotics	Competition from aminoglycoside derivatives and alternatives
Regulatory scrutiny on antibiotic stewardship	Stricter prescribing guidelines, affecting volumes

Regulatory Landscape

• FDA and EMA: Both agencies approve generic formulations with minimal restrictions, encouraging entry by multiple manufacturers.

• WHO Guidelines: Recommends gentamicin for specific indications, albeit with cautious use due to toxicity concerns.

• Antibiotic Stewardship Programs: Aim to optimize use, potentially reducing overall consumption but promoting more targeted therapy.

Manufacturing and Supply Chain Factors

Aspect	Overview
Manufacturing Complexity	Requires sterile conditions; cost-efficient scale-up possible worldwide
Raw Material Availability	Amino sugars and other raw components are widely available
Cost of Production	Estimated USD 0.10–0.20 per vial; price determined by competition
Key Manufacturers	Pfizer, Hikma Pharmaceuticals, Teva, Sandoz, various generics

Financial Trajectory and Future Outlook

Parameter	2022 Values	2025 Projection	2030 Projection
Market Valuation (USD million)	100	115–125	130–150
CAGR	4.2%	3–4%	3–4%
Volume Demand (Units)	Approximately 2.5 million vials	+5–7% growth	+6–8% growth
Pricing Trends	Stable but declining in mature markets	Slight decline due to generic competition	Further stabilization

Note: Projections assume steady antimicrobial use and no major regulatory shocks.

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Comparison with Alternative Aminoglycosides

Drug	Spectrum of Activity	Toxicity Risks	Market Role	Status
Gentamicin	Broad gram-negative bacteria	Nephro- and oto-toxicity	Standard in severe infections	Mature, large global generic market
Tobramycin	Pseudomonas spp.	Similar toxicity	Specific use in cystic fibrosis	Slightly more specialized
Amikacin	Broader spectrum, including resistant strains	Increased toxicity	Last-resort antibiotic options	Premium-priced, less used regularly

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Case Study: Impact of Antimicrobial Resistance on Gentamicin Use

• Rising resistance patterns in Pseudomonas aeruginosa and Klebsiella pneumoniae have compromised gentamicin's efficacy, prompting adjustments in prescribing practices.

• Lab data indicates increasing MIC (minimum inhibitory concentration) thresholds, necessitating higher doses or alternative therapies.

• Clinicians are increasingly reserved for specific indications, indirectly impacting volume and revenue forecasts.

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Comparative Market and Investment Analysis

Criterion	Gentamicin Sulfate	Industry Average
Market Growth Rate	3–4% CAGR	2–3%
Regulatory Complexity	Low	Low
Patent Landscape	Expired, multiple generics	N/A
R&D Investment	Minimal	Moderate to high
Market Concentration	Moderate (several major players)	Moderate

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Key Market Trends

• Shift to Liposomal and Derivative Formulations: To mitigate toxicity, research explores liposomal encapsulation, though commercially limited.

• Increased Use in Combination with Newer Agents: Developing therapies pair gentamicin with agents like beta-lactams or carbapenems for synergism.

• Growth in Hospital and ICU Settings: Emphasized demand during COVID-19, with a slight decline post-pandemic.

• Regulatory Push for Stewardship: Careful balancing between efficacy and safety influences future prescribing patterns.

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Deep Dive: Pricing and Reimbursement Policies

Region	Price Range (per vial USD)	Reimbursement Status	Notes
North America	0.50–2.00	Reimbursed by insurance	Dependent on hospital and insurer policies
Europe	0.30–1.50	Reimbursed, hospital-funded	Variability across countries
Asia-Pacific	0.10–0.80	Limited reimbursement	Price sensitivity influences volume
Africa & LMICs	0.05–0.50	Often out-of-pocket	Market driven by government procurement policies

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Future Opportunities and Threats

Opportunities	Threats
Expanding use in developing countries	Competition from novel antibiotics
Development of less toxic formulations	Increasing antimicrobial resistance
Strategic partnerships with hospitals	Regulatory barriers in certain regions
Incorporation into combination therapies	Stringent stewardship limiting use

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Conclusion

Gentamicin Sulfate remains a vital antibiotic with stable but modest growth prospects. Its market is sustained by applications in severe bacterial infections, especially in regions with limited access to newer therapies. Nonetheless, rising antimicrobial resistance and safety concerns are driving innovation, thereby shaping the future of gentamicin use. Industry players should monitor regulatory policies, resistance trends, and technological advancements for strategic positioning.

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Key Takeaways

• The global gentamicin market was approximately USD 100 million in 2022, projected to grow at 3–4% annually through 2030.

• Market growth is driven by demand in developing regions, hospital use, and combination therapy applications.

• Rising antimicrobial resistance and safety issues pose significant challenges, influencing prescribing practices and R&D.

• Cost dynamics favor generic proliferation, maintaining low prices but limiting revenue potential.

• Future opportunities lie in developing less toxic formulations and combination therapies, while threats include resistance development and stewardship policies.

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FAQs

1. What factors influence the pricing of gentamicin sulfate globally?
Pricing is affected by manufacturing costs, market competition, regional reimbursement policies, and the regulatory environment. Generic dominance contributes to low per-vial prices, especially in LMICs.

2. How does antimicrobial resistance impact gentamicin’s market share?
Rising resistance diminishes gentamicin’s efficacy, prompting clinicians to seek alternative agents, thus reducing demand in certain infections and impacting revenue growth.

3. Are there ongoing developments to improve gentamicin’s safety profile?
Yes. Research includes liposomal formulations and conjugates aimed at reducing nephro- and ototoxicity, potentially expanding its safe use.

4. How are regulatory policies shaping gentamicin’s future?
Regulations emphasizing antimicrobial stewardship limit broad, empirical use, favoring targeted therapy, which constrains volume but ensures sustainable demand.

5. What regions are expected to drive future growth for gentamicin?
Developing countries, particularly in Asia and Africa, are anticipated to sustain growth due to high infection burdens and limited access to newer antibiotics.

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References

[1] MarketResearch.com, “Global Antibiotics Market,” 2022.