AMIKACIN SULFATE - Generic Drug Details

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

Amikacin sulfate is the generic ingredient in five branded drugs marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, Sagent Pharms Inc, Apothecon, and Insmed Inc, and is included in twenty-six NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has two hundred and thirteen patent family members in thirty countries.

There are nine drug master file entries for amikacin sulfate. Seven suppliers are listed for this compound.

Summary for AMIKACIN SULFATE

International Patents:	213
US Patents:	14
Tradenames:	5
Applicants:	11
NDAs:	26
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMIKACIN SULFATE
What excipients (inactive ingredients) are in AMIKACIN SULFATE?	AMIKACIN SULFATE excipients list
DailyMed Link:	AMIKACIN SULFATE at DailyMed

Recent Clinical Trials for AMIKACIN SULFATE

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

Sponsor	Phase
Centre hospitalier de Perpignan	PHASE2
CH Pontoise	PHASE2
IHU Strasbourg	PHASE2

See all AMIKACIN SULFATE clinical trials

Pharmacology for AMIKACIN SULFATE

Drug Class

Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for AMIKACIN SULFATE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMIKACIN 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

US Patents and Regulatory Information for AMIKACIN SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063275-001	May 18, 1992		DISCN	No	No
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063315-001	Apr 11, 1994	AP	RX	No	No
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063313-001	Apr 11, 1994		RX	No	Yes

Expired US Patents for AMIKACIN SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	7,718,189
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	9,827,317
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	8,802,137

International Patents for AMIKACIN SULFATE

Country	Patent Number	Title	Estimated Expiration
South Korea	102277921
Hong Kong	1202812	治療肺部感染的系統 (SYSTEMS FOR TREATING PULMONARY INFECTIONS)
Canada	2838108	SUBSTANCES ANTI-INFECTIEUSES A LIBERATION LENTE (SUSTAINED RELEASE OF ANTIINFECTIVES)

Market Dynamics and Financial Trajectory for Amikacin Sulfate

Last updated: July 27, 2025

Introduction

Amikacin sulfate, a potent aminoglycoside antibiotic primarily utilized for serious bacterial infections, occupies a significant niche within the antimicrobial market. Its efficacy against multidrug-resistant organisms and certain Gram-negative bacteria sustains demand amid escalating antimicrobial resistance. This analysis explores the market dynamics shaping amikacin sulfate's commercial landscape, its evolving financial trajectory, and the key factors influencing future growth.

Current Market Landscape

Market Size and Regional Distribution

The global amikacin sulfate market was valued at approximately USD 300 million in 2022, with expectations of compound annual growth rates (CAGR) of 4-6% over the next five years. North America holds the largest share, driven by high healthcare spending, stringent infection control protocols, and robust hospital systems. Europe follows closely, with Asia-Pacific emerging as a significant growth region owing to expanding healthcare infrastructure and increasing bacterial infection incidences [1].

Key Segments and End-User Profiles

The primary end-users encompass hospitals, clinics, and pharmacies. Hospitals dominate due to their reliance on intravenous (IV) formulations for inpatient care. The pharmaceutical segment involves both branded and generic manufacturers, with the latter accounting for the majority of market volume due to cost advantages and regulatory approvals.

Competitive Landscape

Major global players include Lupin Limited, Hikma Pharmaceuticals, Sagent Pharmaceuticals, and Gland Pharma. These companies leverage their manufacturing capacities, research capabilities, and distribution networks to sustain market share. Patent expiry and the availability of generics have intensified price competition, influencing profitability margins but expanding market access [2].

Market Drivers

Rising Antibiotic Resistance

The surge in multidrug-resistant bacterial strains, particularly Gram-negative pathogens like Pseudomonas aeruginosa and Acinetobacter baumannii, amplifies demand for effective antibiotics such as amikacin. Its efficacy against resistant strains underpins its essential role in hospital-acquired infections.

Emerging Infections and Outbreaks

Global incidences of infectious diseases—ranging from sepsis to complicated pneumonia—drive utilization within intensive care units (ICUs). The ongoing COVID-19 pandemic further amplified the focus on managing secondary bacterial infections, sustaining demand for antibiotics including amikacin.

Regulatory Approvals and Prescriptions

Regulatory approvals by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for formulations, including generic versions, bolster market proliferation. Moreover, inclusion in treatment guidelines enhances prescribing practices.

Advancements in Manufacturing

Manufacturers employing novel synthesis and purification techniques enhance product quality, reduce costs, and boost supply chain resilience. These efficiencies support market growth amidst demand volatility.

Market Restraints

Toxicity and Side Effects

Amikacin’s potential nephrotoxicity and ototoxicity limit its use, necessitating careful monitoring. These adverse effects restrict broader application and prompt the development of safer alternatives.

Emergence of Newer Antibiotics

Innovative agents with improved safety profiles, such as tigecycline and colistin, compete with amikacin, influencing prescribing preferences. The pipeline of next-generation antibiotics could further undermine demand.

Regulatory Challenges

Stringent regulatory requirements regarding manufacturing standards and clinical efficacy might delay approvals for new formulations or generic variants, impacting revenue streams.

Cost Constraints in Low-Income Settings

Budget limitations in developing countries hamper access, curbing market expansion despite high disease burdens.

Financial Trajectory and Future Outlook

Revenue Projections

The upcoming five-year horizon anticipates moderate growth for amikacin sulfate, driven predominantly by emerging markets and the off-label application expansion. The patent expirations of several formulations are expected to catalyze generic market penetration, resulting in price reductions but increased volume sales.

Impact of Generic Competition

The proliferation of generic amikacin brands post-patent expiry significantly enhances accessibility and affordability. While this intensifies price competition, volume increases are predicted to offset margin pressures, favoring overall revenue growth for manufacturers.

Technological and Formulation Innovations

Innovations such as liposomal delivery systems and controlled-release formulations are in developmental stages, promising to mitigate toxicity and improve patient compliance. Their commercialization could command premium pricing and capture new segments.

Market Expansion Factors

Emerging countries' expanding healthcare infrastructure and rising bacterial infection rates signal upward market trends. Public health initiatives and antimicrobial stewardship policies influence usage patterns but generally favor the sustained role of amikacin.

Potential Disruptors

The development of rapid diagnostic tools enabling targeted therapy and personalized medicine could reduce empirical use of broad-spectrum agents like amikacin. Additionally, resistance development against aminoglycosides remains a perpetual concern impacting long-term viability.

Regulatory and Policy Impacts

Governmental policies aimed at combating antimicrobial resistance (AMR), such as stewardship programs and restrictions on antibiotic overuse, influence prescribing patterns. Stringent regulations could impose hurdles but also stimulate innovation and safety improvements, potentially opening new market avenues.

Conclusion

Amikacin sulfate remains a critical component of the antimicrobial arsenal against resistant bacterial infections. Its market is characterized by steady growth, propelled by rising resistance, expanding healthcare access in emerging economies, and ongoing generic competition. Nevertheless, toxicity concerns, regulatory hurdles, and evolving resistance patterns necessitate strategic adaptation by industry participants. The future financial trajectory appears cautiously optimistic, with innovation and market expansion serving as primary growth catalysts.

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Key Takeaways

• Growing Need for Effective Antibiotics: The rise in multidrug-resistant infections sustains demand for amikacin, especially in hospital settings.

• Generic Market Dynamics: Post-patent expiry, proliferation of generics expands access but exerts downward pressure on pricing margins.

• Innovation as a Growth Lever: Formulation advancements targeting toxicity reduction can provide competitive advantages and premium pricing opportunities.

• Emerging Markets as Growth Drivers: Healthcare infrastructure expansion and infection prevalence in developing regions underpin future market expansion.

• Regulatory and Stewardship Challenges: Evolving policies necessitate adaptation, emphasizing safety and rational use, which may impact demand patterns.

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FAQs

Q1: What factors most significantly influence the pricing of amikacin sulfate in different markets?
A: Key factors include manufacturing costs, the degree of generic competition, regulatory approval status, regional healthcare policies, and the overall demand-supply balance.

Q2: Are there promising innovations that could address amikacin's toxicity concerns?
A: Yes. Liposomal delivery systems and controlled-release formulations are under development to improve safety profiles by reducing peak plasma concentrations that cause toxicity.

Q3: How does antimicrobial resistance affect the future of amikacin sulfate?
A: Rising resistance against aminoglycosides may limit efficacy, prompting the need for combination therapies or alternative agents. Continuous surveillance and stewardship are essential.

Q4: What role do regulatory agencies play in shaping the amikacin market?
A: Regulatory agencies influence market dynamics via approval processes, safety guidelines, and policies promoting or restricting antibiotic use, thereby impacting market entry and expansion.

Q5: How can manufacturers capitalize on emerging market opportunities for amikacin sulfate?
A: By investing in manufacturing efficiencies, fostering clinical evidence to support expanded use, and complying with evolving regulatory standards, companies can leverage growth in emerging economies.

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References

[1] Global Market Insights. (2022). Antibiotics Market Size, Growth & Trends.

[2] IQVIA. (2022). Pharmaceuticals Market Data.