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, Taro, 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, 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-seven suppliers are listed for this compound.

Summary for GENTAMICIN SULFATE

US Patents:	0
Tradenames:	12
Applicants:	35
NDAs:	62
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	13
Patent Applications:	627
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
Kaiser Permanente	Phase 2
University of California, San Diego	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
Pharmafair	GENTAFAIR	gentamicin sulfate	INJECTABLE;INJECTION	062493-001	Aug 28, 1985		DISCN	No	No
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	062588-009	Jan 6, 1986		DISCN	No	No
Baxter Hlthcare	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062373-002	Sep 7, 1982	AP	RX	No	No
Baxter Hlthcare	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	gentamicin sulfate	INJECTABLE;INJECTION	062373-007	Sep 7, 1982	AP	RX	No	No

GENTAMICIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gentamicin Sulfate

Introduction to Gentamicin Sulfate

Gentamicin sulfate is a widely used antibiotic belonging to the aminoglycoside class, effective against a broad spectrum of gram-negative and some gram-positive bacteria. It is utilized in various medical applications, including injections, eye drops, and sustained-release formulations.

Current Market Trends

Increasing Demand

The global gentamicin sulfate market has been experiencing an upswing trend, driven by consistent increases in end-user demand from the downstream sector. This surge is particularly notable in regions such as Europe, where countries like Germany have seen moderate increases in inquiries since January 2023[1].

Geographical Market Dynamics

• Europe: The European market, especially in Germany, has shown a significant rise in demand. This is partly due to an increase in domestic consumption rates, reflected in the Consumer Price Index (CPI) which climbed from 114.30 to 115.20 points in February 2023[1].
• United States: The U.S. market also follows a similar trend, with demand influenced by environmental conditions and the spread of antibiotic-resistant infections[1].
• Asia-Pacific: China has witnessed a significant demand for gentamicin sulfate, both domestically and internationally. Production activities have resumed to meet the increasing demand, leading to a 2% price appreciation in February 2023[1].

Market Segmentation and Applications

Types of Gentamicin Sulfate

The market is segmented based on the purity of gentamicin sulfate, including 99%, 98%, and 95% purity types. Each type has different applications and market dynamics[4].

Applications

Gentamicin sulfate is used in various forms:

• Gentamicin Sulfate Injection: Commonly used for parenteral administration, particularly effective in treating severe infections such as sepsis, meningitis, and pneumonia[2][5].
• Gentamicin Sulfate Eye Drops: Used for ocular infections.
• Gentamicin Sulfate Tablets and Granules: For oral administration.
• Antibiotic-Loaded Bone Cement: This application is gaining traction, especially in orthopedic surgeries to prevent infections in knee and hip replacements[3].

Financial Trajectory

Market Size and Growth Projections

The global gentamicin sulfate market is anticipated to experience robust growth from 2023 to 2031. The market size is projected to expand significantly, driven by increasing demand and advancements in medical applications. The market is expected to grow at a steady rate, with the global market size valued in USD millions across various segments[4].

Pricing and Supply Dynamics

The prices of gentamicin sulfate have seen fluctuations based on demand and supply. In February 2023, prices rose by 2% due to increased demand, but a stable decrease in demand is expected to reduce prices by 1% in the forthcoming months[1].

Regional Market Performance

• North America: The U.S. is expected to remain a lucrative market due to advanced bone grafting procedures and a favorable reimbursement landscape[3].
• Europe: Countries like Germany, the UK, France, Italy, and others are anticipated to witness sound growth prospects[3].
• Asia-Pacific: China, India, and Japan are expected to see maximum growth due to increasing access to healthcare facilities and enhancing healthcare infrastructure[3].

Drivers and Restraints

Drivers

• Increasing Prevalence of Infections: The rise in antibiotic-resistant infections and the need for effective treatments drive the demand for gentamicin sulfate[1][2].
• Advancements in Medical Applications: The use of gentamicin sulfate in antibiotic-loaded bone cement and other orthopedic applications is a significant driver[3].
• Growing Elderly Population: The increasing number of elderly individuals undergoing surgeries like knee and hip replacements fuels the demand for gentamicin sulfate[3].

Restraints

• Side Effects and Toxicity: Gentamicin sulfate can cause nephrotoxicity and neurotoxicity, especially in patients with renal impairment or those receiving high doses or prolonged therapy. This can limit its use in certain cases[2].
• Regulatory and Quality Standards: The need to meet pharmacopeial specifications and regulatory requirements can be a restraint, especially for manufacturers[5].

Competitive Landscape

The gentamicin sulfate market includes several key players such as Fresenius Kabi, Hospira, and other pharmaceutical companies. These players are investing in research and development to offer more efficient products and are involved in mergers and acquisitions to strengthen their market position[4][5].

Product Advancements and Launches

Market players are focusing on product advancements, such as the development of antibiotic-loaded bone cement, which is gaining traction in orthopedic surgeries. The mix of vancomycin and ciprofloxacin is also anticipated to gain market share due to its stronger release profile compared to hydrochloride ciprofloxacin alone[3].

Conclusion

The gentamicin sulfate market is poised for significant growth driven by increasing demand, advancements in medical applications, and a growing elderly population. However, the market must navigate challenges such as side effects, regulatory standards, and competitive dynamics.

Key Takeaways

• Increasing Demand: Driven by end-user demand and environmental factors.
• Geographical Growth: Europe, the U.S., and Asia-Pacific regions are key markets.
• Market Segmentation: Based on purity and applications such as injections, eye drops, and antibiotic-loaded bone cement.
• Financial Projections: Robust growth from 2023 to 2031.
• Drivers and Restraints: Increasing infections, medical advancements, and side effects are key factors.
• Competitive Landscape: Includes major pharmaceutical companies with a focus on R&D and mergers.

FAQs

Q1: What are the primary applications of gentamicin sulfate? Gentamicin sulfate is used in various forms, including injections for parenteral administration, eye drops for ocular infections, and antibiotic-loaded bone cement for orthopedic surgeries.

Q2: Which regions are expected to see significant growth in the gentamicin sulfate market? The U.S., Europe (especially Germany), and Asia-Pacific regions (including China, India, and Japan) are anticipated to witness significant growth.

Q3: What are the potential side effects of gentamicin sulfate? Gentamicin sulfate can cause nephrotoxicity and neurotoxicity, particularly in patients with renal impairment or those receiving high doses or prolonged therapy.

Q4: How does the pricing of gentamicin sulfate fluctuate? Prices fluctuate based on demand and supply. For example, in February 2023, prices rose by 2% due to increased demand but are expected to reduce by 1% in forthcoming months.

Q5: What are the key drivers of the gentamicin sulfate market? The key drivers include the increasing prevalence of antibiotic-resistant infections, advancements in medical applications, and the growing elderly population undergoing surgeries.

Sources

1. ChemAnalyst: "Gentamicin Sulphate Market Follows an Upswing Trend Across the Globe"[1]
2. Drugs.com: "Gentamicin Sulfate: Package Insert / Prescribing Info"[2]
3. Fact.MR: "Antibiotic-loaded Bone Cement Demand Spurred by Incessant Research and Development"[3]
4. Market Research Intellect: "Global Gentamycin Sulfate Market Size, Trends and Projections"[4]
5. Global Health Supply Chain: "GENTAMICIN"[5]