AMIKACIN SULFATE Drug Patent Profile

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

Amikacin Sulfate is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, and Sagent Pharms Inc. and is included in twenty-one NDAs.

The generic ingredient in AMIKACIN SULFATE 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 Amikacin Sulfate

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

Summary for AMIKACIN SULFATE

US Patents:	0
Applicants:	9
NDAs:	21
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	6
Patent Applications:	51
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMIKACIN SULFATE
DailyMed Link:	AMIKACIN SULFATE at DailyMed

Recent Clinical Trials for AMIKACIN SULFATE

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

Sponsor	Phase
Central Hospital Saint Quentin	PHASE2
CH Orléans	PHASE2
Hospital Avicenne	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
Abbott	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063265-001	Nov 30, 1994		DISCN	No	No
Igi Labs Inc	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063169-001	Dec 14, 1995		DISCN	No	No
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063313-001	Apr 11, 1994		RX	No	Yes
Fresenius Kabi Usa	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	205605-001	Dec 9, 2015		DISCN	No	No
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063283-001	Oct 31, 1994		DISCN	No	No
Meitheal	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	064045-002	Sep 28, 1993	AP	RX	No	No
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063275-001	May 18, 1992		DISCN	No	No

Last updated: February 4, 2026

Market Dynamics and Financial Trajectory for Amikacin Sulfate

Market Overview

Amikacin sulfate is an aminoglycoside antibiotic used primarily for severe bacterial infections resistant to other antibiotics. It is administered via injection, often in hospital settings. The drug addresses gram-negative bacterial infections, including strains resistant to older aminoglycosides like gentamicin and tobramycin.

Key Market Drivers

• Rising Antibiotic Resistance: Increasing incidence of multi-drug resistant (MDR) gram-negative bacteria broadens the need for potent antibiotics such as amikacin.
• Hospital-acquired Infections: Growth in nosocomial infections, particularly pneumonia and sepsis, sustains demand for intravenous antibiotics.
• Treatment of Specific Resistant Strains: Amikacin's efficacy against resistant strains makes it a primary choice in certain treatment protocols and for infections in immunocompromised patients.
• Limited Market Competition: Currently, few alternatives match amikacin's spectrum of activity, especially in resistant cases, providing manufacturers some pricing power.

Market Challenges

• Toxicity Concerns: Ototoxicity and nephrotoxicity limit prolonged use, raising safety concerns and affecting prescribing habits.
• Generic Competition: Multiple pharmaceutical companies produce generic amikacin, constraining margins.
• Regulatory Scrutiny: Increasing regulations on antibiotic use encourage stewardship programs to minimize overuse, impacting sales volume.

Market Size and Growth

The global amikacin market valued approximately USD 415 million in 2021. It is expected to grow at a compound annual growth rate (CAGR) of 3-5% through 2030, driven largely by the rising prevalence of resistant infections.

Year	Market Value (USD Million)	CAGR (%)
2021	415	--
2025	510	4
2030	620	4.2

Source: Mordor Intelligence, 2022

Regional analysis highlights North America as the largest market, accounting for over 40% share in 2021, due to advanced healthcare infrastructure and high antibiotic resistance rates. Asia-Pacific shows the fastest growth, driven by expanding healthcare access and rising bacterial infection incidences.

Key Industry Participants

Major manufacturers include:

• Pfizer Inc. (current market leader with established manufacturing capabilities)
• Bausch Health (distributes generic formulations)
• Sagent Pharmaceuticals (specializes in injectable antibiotics)
• Generic pharmaceutical companies producing over-the-counter formulations

Financial Trajectory

Financial projections reveal moderate growth margins constrained by the following factors:

• Pricing Pressure: High competition and patent expirations reduce prices.
• R&D Cost: Investment in new formulations or derivatives is necessary for differentiation but involves significant costs.
• Generic Market Penetration: Ease of manufacturing reduces barriers for entrants, intensifying price competition.

Profitability Outlook: Gross margins hover around 35-45% for leading producers, with net margins between 10-15%. Revenue growth will continue at low double digits unless new formulations or indications are developed.

Regulatory and Policy Impact

Increased emphasis on antibiotic stewardship efforts influences prescribing patterns, leading to more conservative utilization of amikacin. Regulatory agencies such as the FDA enforce guidelines that limit overuse, potentially slowing market growth but focusing sales on severe cases where benefits outweigh risks.

Investment and R&D Trends

Emerging research explores targeted delivery systems to reduce toxicity, combination therapies to enhance efficacy, and novel derivatives with improved safety profiles. Investment in these areas indicates potential for market expansion and financial upside.

Summary of Market Risks

• Public health campaigns against antibiotic overuse may reduce demand.
• Toxicity concerns can limit prescribing, especially in outpatient settings.
• Rapid growth of generic manufacturers increases price competition, affecting profit margins.

Key Takeaways

• The global amikacin sulfate market is characterized by stable demand due to increasing antibiotic resistance.
• Growth is constrained by toxicity issues, pricing pressures, and regulatory oversight.
• Regional disparities favor North America and Asia-Pacific markets.
• Innovation efforts focus on improving safety and expanding indications, which can alter the financial trajectory.
• Industry profitability relies heavily on patent expiration timelines and competitive dynamics.

FAQs

1. Why is amikacin sulfate preferred for resistant bacterial infections?
Amikacin has a broader spectrum against resistant gram-negative bacteria and retains activity when other aminoglycosides fail, making it invaluable in resistant infections.

2. What is the primary factor limiting amikacin market growth?
Concerns over toxicity, especially nephrotoxicity and ototoxicity, restrict its use to severe cases, limiting sales volume.

3. How does antibiotic resistance influence the amikacin market?
Rising resistance increases demand among hospitals for potent antibiotics like amikacin, but stewardship practices can curtail unnecessary usage.

4. What are the prospects of patent protections affecting commercial profitability?
Most formulations are now generic, so patent protections offer limited exclusivity, intensifying price pressures.

5. Are there new innovations that could impact the market?
Yes, research on targeted delivery, combination therapies, and safer derivatives has the potential to revive growth and expand use cases.

---

Sources

1. Mordor Intelligence. "Global Amikacin Market," 2022.
2. IQVIA. "Pharmaceutical Market Reports," 2021.
3. FDA. "Guidelines on Antibiotic Stewardship," 2019.
4. MarketWatch. "Antibiotic Resistance Trends," 2021.
5. GlobalData. "Infection Control and Antibiotic Market Analysis," 2020.