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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has two hundred and eight patent family members in twenty-nine countries.

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

Summary for AMIKACIN SULFATE

International Patents:	208
US Patents:	13
Tradenames:	5
Applicants:	11
NDAs:	26
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	5
Patent Applications:	5
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
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Insmed Incorporated	Phase 2

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
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	064098-001	Jun 26, 1995		DISCN	No	No
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063350-002	Jul 30, 1993		DISCN	No	No
Fresenius Kabi Usa	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	205605-001	Dec 9, 2015		DISCN	No	No
Qilu	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	218146-001	Mar 19, 2024	AP	RX	No	No

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	8,802,137
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	9,827,317

International Patents for AMIKACIN SULFATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20080027888	SUSTAINED RELEASE OF ANTIINFECTIVES
Poland	2852391
Israel	216401	תכשיר אנטי-זיהומי המכיל אמיקצין ותערובת שומנים ושיטה להכנתו (Antiinfective formulation comprising amikacin and a lipid mixture and method of its preparation)
Japan	5684343

AMIKACIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amikacin Sulfate

Introduction to Amikacin Sulfate

Amikacin sulfate is a potent aminoglycoside antibiotic used to treat serious bacterial infections, including pneumonia, sepsis, and meningitis. It works by inhibiting protein synthesis in bacteria, making it a crucial component in the treatment of various bacterial infections.

Market Growth and Forecast

The global amikacin sulfate market is anticipated to experience steady growth over the coming years. Here are some key points:

• CAGR and Market Size: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period, reaching USD 1.2 billion by 2028[1].
• Driving Factors: The growth is driven by the increasing prevalence of bacterial infections and the rising demand for amikacin sulfate injections in emerging economies such as India and China[1].

Market Segmentation

The amikacin sulfate market is segmented based on several criteria:

• Type: The market is segmented into purity levels, including purity greater than or equal to 98% and purity greater than or equal to 99%[1].
• Application: The primary application is amikacin sulfate injection, which is used to treat a variety of bacterial infections[1].
• Region: The market is analyzed across regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America[1].

Key Players and Market Share

Several pharmaceutical companies are prominent in the amikacin sulfate market:

• Major Players: Companies like Chengdu Brilliant Pharmaceutical Group, Chongqing Daxin Pharmaceutical, Interquim Mexico, CONBA Group, Suanfarma, and Qilu Pharmaceutical are key players in this market[1][4].
• Market Share: These companies contribute significantly to the market share, with each having a notable presence in different regions and product segments[1].

Financial Performance and Revenue

The financial trajectory of amikacin sulfate is closely tied to its market performance and the success of its applications:

• Revenue Growth: The market revenue is expected to increase due to the growing demand for amikacin sulfate injections. For instance, the global market is projected to reach USD 1.2 billion by 2028[1].
• Regional Revenue: In terms of regional performance, Asia Pacific, particularly countries like China and India, is expected to contribute significantly to the revenue growth due to the increasing prevalence of bacterial infections and the expanding healthcare infrastructure[1].

Amikacin Liposome Inhalation Suspension (ARIKAYCE)

A notable derivative of amikacin is the amikacin liposome inhalation suspension, marketed as ARIKAYCE by Insmed Incorporated:

• Revenue: ARIKAYCE has shown significant revenue growth, with total revenue of $305.2 million for the full year 2023, reflecting a 24% annual growth compared to 2022[3].
• Geographical Performance: The product has seen strong growth in the U.S., Japan, and Europe, with year-over-year growth of 21% in the U.S. and 16% in Japan[3].
• Future Outlook: Insmed has reiterated its sales guidance for 2024, expecting global ARIKAYCE revenues in the range of $340 million to $360 million, representing a 15% year-over-year growth at the midpoint[3].

Cost and Pricing

The cost and pricing dynamics of amikacin sulfate are influenced by several factors:

• Product Costs: The cost of product revenues, excluding amortization of intangibles, has increased with the rise in sales volumes. For example, Insmed reported $16.7 million in cost of product revenues for the third quarter of 2023, up from $13.5 million in the third quarter of 2022[2].
• Pricing Trends: The pricing of amikacin sulfate injections can vary based on purity levels and regional markets. Companies often adjust pricing strategies to balance profitability with market demand and competition[1].

Regulatory and Clinical Aspects

Regulatory approvals and clinical trials play a crucial role in the market dynamics of amikacin sulfate:

• Regulatory Approvals: Amikacin sulfate has been approved for use in the United States since 1978 and is available in both intravenous and intramuscular forms[1].
• Clinical Trials: Insmed's post-marketing trials, such as the ARISE and ENCORE studies for ARIKAYCE, are critical for expanding the product's indications and reinforcing its efficacy and safety profile[2][3].

Market Challenges and Opportunities

The market for amikacin sulfate faces several challenges and opportunities:

• Challenges: Resistance to antibiotics, stringent regulatory requirements, and competition from other antibiotics are significant challenges. Additionally, the need for careful dosing to avoid ototoxicity and nephrotoxicity can limit its use[1][5].
• Opportunities: Emerging markets, increasing bacterial infections, and the development of new formulations like liposome inhalation suspensions offer significant opportunities for growth[1][2].

Regional Analysis

The geographical distribution of the market highlights varying levels of demand and growth:

• Asia Pacific: This region is expected to be a major driver of growth due to the large population and increasing healthcare needs in countries like China and India[1].
• North America and Europe: These regions also contribute significantly, with a focus on advanced healthcare systems and higher spending on pharmaceuticals[1].

Conclusion

The market for amikacin sulfate is poised for steady growth driven by increasing demand for effective antibiotics, particularly in emerging economies. Key players are investing in product development and expansion, while regulatory and clinical activities continue to shape the market.

Key Takeaways

• Market Growth: Expected to grow at a CAGR of 3.5% to reach USD 1.2 billion by 2028.
• Key Players: Companies like Chengdu Brilliant Pharmaceutical Group, Chongqing Daxin Pharmaceutical, and Qilu Pharmaceutical are major players.
• Regional Performance: Asia Pacific, especially China and India, is a significant growth driver.
• ARIKAYCE Performance: Strong revenue growth with $305.2 million in full-year 2023 revenues.
• Regulatory and Clinical: Ongoing clinical trials and regulatory approvals are crucial for market expansion.

FAQs

Q: What is the primary use of amikacin sulfate? A: Amikacin sulfate is primarily used to treat serious bacterial infections such as pneumonia, sepsis, and meningitis.

Q: Which regions are expected to drive the growth of the amikacin sulfate market? A: The Asia Pacific region, particularly countries like China and India, is expected to be a major driver of growth.

Q: What is ARIKAYCE, and how is it related to amikacin sulfate? A: ARIKAYCE is an amikacin liposome inhalation suspension used to treat certain bacterial infections, and it is a derivative of amikacin sulfate.

Q: What are the key challenges facing the amikacin sulfate market? A: The market faces challenges such as antibiotic resistance, stringent regulatory requirements, and competition from other antibiotics.

Q: Which companies are major players in the amikacin sulfate market? A: Companies like Chengdu Brilliant Pharmaceutical Group, Chongqing Daxin Pharmaceutical, and Qilu Pharmaceutical are major players in this market.

Sources

1. Industry Growth Insights: Amikacin Sulfate Market Report | Global Forecast To 2028
2. PR Newswire: Insmed Reports Third-Quarter 2023 Financial Results and Provides Business Update
3. Insmed Investor Relations: Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update
4. Valuates Reports: Global Amikacin Sulfate Injection Market Research Report 2023
5. MedChemExpress: Amikacin sulfate (BAY 41-6551 sulfate) | Aminoglycoside Antibiotic