AMIKIN Drug Patent Profile

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

Amikin is a drug marketed by Apothecon and is included in four NDAs.

The generic ingredient in AMIKIN is amikacin sulfate. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amikin

A generic version of AMIKIN was approved as amikacin sulfate by MEITHEAL on September 28^th, 1993.

Summary for AMIKIN

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
DailyMed Link:	AMIKIN at DailyMed

Recent Clinical Trials for AMIKIN

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

Sponsor	Phase
Raja Isteri Pengiran Anak Saleha Hospital	N/A
Thammasat University	N/A

See all AMIKIN clinical trials

US Patents and Regulatory Information for AMIKIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062311-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-002	Nov 30, 1987		DISCN	No	No
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062311-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-001	Nov 30, 1987		DISCN	No	No
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062562-001	Sep 20, 1984		DISCN	No	No

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AMIKIN

Introduction
AMIKIN, the brand name for amikacin, is an aminoglycoside antibiotic primarily used to treat serious bacterial infections. With a longstanding history of clinical use, its market dynamics are shaped by factors including antimicrobial resistance trends, regulatory landscapes, and evolving treatment protocols. This analysis explores these driving forces and projects the financial trajectory of AMIKIN within the current pharmaceutical ecosystem.

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Market Landscape and Demand Drivers

Global Prevalence of Bacterial Infections
AMIKIN's core indication targets severe Gram-negative bacterial infections, particularly in hospital settings. As antimicrobial resistance (AMR) escalates globally, infections caused by multidrug-resistant (MDR) pathogens such as Pseudomonas aeruginosa and Acinetobacter baumannii increasingly require potent antibiotics like amikacin. The World Health Organization (WHO) recently classified AMR as a top threat, heightening demand for effective antimicrobials, especially in intensive care units (ICUs) [1].

Antimicrobial Resistance (AMR) Trends
AMIKIN's utility is reinforced by the rising prevalence of MDR strains resistant to first-line antibiotics. Its mechanism—binding to the 30S ribosomal subunit—confers efficacy where other agents falter. However, the development of resistance even against aminoglycosides poses challenges, pushing for judicious use and stewardship programs to sustain its effectiveness.

Hospital and Critical Care Markets
The inpatient sector, especially ICUs, constitutes the primary market for AMIKIN. Increasing rates of nosocomial infections and the growing prevalence of invasive procedures elevate the demand. The global ICU market, projected to grow at approximately 6.5% CAGR through 2030, indirectly propels aminoglycoside use [2].

Regulatory Environment and Approvals
While amikacin has been off-patent for decades, recent regulatory initiatives focus on optimizing existing antibiotics to combat AMR. No novel indications or formulations specific to AMIKIN have gained recent approvals, but ongoing clinical trials investigating combination therapies and new delivery methods could expand its use.

Key Market Players and Competition
MUCH of the AMIKIN market is supplied by generic manufacturers due to patent expiration. Brand-name versions like Amphotec® (amphotericin B) are less directly competitive but signal the commoditized nature of aminoglycosides. The main competitors are other aminoglycosides (gentamicin, tobramycin) and newer classes like lipoglycopeptides and polymyxins.

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Financial Trajectory and Revenue Outlook

Last updated: July 30, 2025

Revenue Generation and Market Share
According to industry reports, the global aminoglycoside antibiotics market is valued at approximately USD 300 million (as of 2022) with a projected CAGR of 4-6% over the next five years [3]. AMIKIN-specific revenues mostly derive from hospital procurement contracts. Large generic manufacturers dominate the sales volume, with AMIKIN constituting a significant share owing to its broad spectrum and clinical familiarity.

Pricing Dynamics
Since AMIKIN's patent expiry, price competition has intensified, exerting downward pressure on profit margins. Nonetheless, hospitals tend to prioritize proven efficacy in severe infections, maintaining a steady procurement pattern. Emergency use and off-label indications, though limited, can occasionally influence pricing strategies.

Impact of Biosimilars and Generics
Market entry by biosimilars and generics has contributed to price erosion. However, the unique niche of AMIKIN in MDR infections preserves some premium pricing for specialized hospital use. Innovators and originators may adopt value-added formulations (e.g., liposomal encapsulation) to differentiate, although these are not yet widespread.

Potential for Market Expansion
While the core use remains stable, potential growth avenues include combination therapies for resistant infections, aerosolized formulations for pulmonary infections, and applications in emerging indications. Such innovations could enhance revenue streams, especially in regions with high antibiotic resistance burdens.

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Market Challenges and Opportunities

Challenges

• Rising Resistance: Development of amikacin resistance could diminish its clinical utility.
• Toxicity Profile: Ototoxicity and nephrotoxicity limit widespread usage, especially in outpatient settings, capping market expansion.
• Regulatory Scrutiny: Stringent regulatory standards for antibiotic stewardship may constrain volume growth.
• Market Saturation: Extensive generic competition compresses margins and deters R&D investment.

Opportunities

• Innovation in Delivery: Long-acting formulations and inhalation delivery promise tailored therapeutic options.
• Combination Strategies: Synergistic regimens with other antibiotics can rejuvenate AMIKIN's market relevance.
• Addressing AMR: As global health initiatives emphasize combatting resistance, AMIKIN may benefit from favorable policy support.
• Growing Healthcare Infrastructure: Expansion of hospital systems in emerging markets enhances demand.

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Forecasting and Future Outlook

Short-term (1-3 years)
The market for AMIKIN is expected to remain relatively stable, driven predominantly by existing hospital procurement. Margins may face slight compression due to generic competition, but stable demand from MDR infection management sustains revenues.

Medium to Long-term (3-10 years)
Emerging formulations and combination therapies could unlock new revenue streams. As antimicrobial stewardship tightens, usage may shift toward targeted, high-value applications rather than broad-spectrum employment. Investment in resistance monitoring and clinical trials might position AMIKIN favorably within the evolving landscape.

Key Takeaways

• AMIKIN's market is driven by increasing MDR bacterial infections, especially in hospital settings.
• Generics dominate supply, exerting downward pressure on prices, but critical clinical efficacy sustains demand.
• Innovations in delivery and combination therapy present growth opportunities, countering resistance challenges.
• The global focus on antimicrobial resistance may enhance AMIKIN's strategic importance and regulatory support.
• Market expansion depends on balancing resistance management, toxicity mitigation, and deploying innovative formulations.

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Conclusion
AMIKIN’s financial trajectory hinges on its capacity to adapt within a highly competitive, resistance-pressured environment. Its entrenched position in serious bacterial infections ensures baseline revenue streams, but sustained growth requires innovation, targeted application, and prudent stewardship. Stakeholders must align R&D and supply chain strategies with these dynamics to optimize profitability and public health impact.

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FAQs

1. How does antimicrobial resistance impact the future demand for AMIKIN?
Rising AMR, especially in Gram-negative bacteria, sustains AMIKIN’s relevance in hospital settings. However, increasing resistance may eventually limit its efficacy if resistance genes proliferate rapidly, potentially reducing demand unless complemented by new formulations or combination therapies.

2. Are there any new formulations or delivery methods for AMIKIN under development?
Currently, research focuses on inhalation therapies for pulmonary infections and liposomal formulations to reduce toxicity. These innovations aim to expand use cases and improve safety profiles, which could positively influence market growth.

3. What are the primary challenges facing AMIKIN manufacturers?
Key challenges include price erosion due to generic competition, toxicity management, regulatory pressures, and the development of resistance, all of which threaten profit margins and market share.

4. Can AMIKIN leverage global health initiatives aimed at combating AMR?
Yes. Increased policy support, funding, and antimicrobial stewardship programs tailored to combat resistant infections favor the strategic positioning of AMIKIN, especially if aligned with efforts to optimize existing antibiotics.

5. Is there potential for geographic market expansion for AMIKIN?
Emerging markets with expanding healthcare infrastructures and high antimicrobial resistance are promising. However, local regulatory approvals, pricing, and stewardship practices will influence uptake.

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References
[1] WHO Antimicrobial Resistance Global Report, 2022.
[2] MarketsandMarkets. ICU Market Analysis, 2022.
[3] Grand View Research. Antibiotics Market Size & Growth, 2022.