NEOMYCIN SULFATE - Generic Drug Details

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

Neomycin sulfate is the generic ingredient in thirteen branded drugs marketed by Pharmacia And Upjohn, X Gen Pharms, Pfizer, Adrastea Pharma, Bristol Myers Squibb, Chartwell Molecular, Lannett, Lilly, Nostrum Labs Inc, Roxane, Sandoz, Teva, Glaxosmithkline, Alcon, Watson Labs, Xgen Pharms, Monarch Pharms, Allergan, Merck, Savage Labs, Fougera, and Pharmaderm, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for neomycin sulfate. Four suppliers are listed for this compound.

Summary for NEOMYCIN SULFATE

US Patents:	0
Tradenames:	13
Applicants:	22
NDAs:	31
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	11
Patent Applications:	7,004
What excipients (inactive ingredients) are in NEOMYCIN SULFATE?	NEOMYCIN SULFATE excipients list
DailyMed Link:	NEOMYCIN SULFATE at DailyMed

Recent Clinical Trials for NEOMYCIN SULFATE

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

Sponsor	Phase
Vietstar Biomedical Research	N/A
Huro Biotech Joint Stock Company	N/A
Mahidol University	Phase 4

See all NEOMYCIN SULFATE clinical trials

Pharmacology for NEOMYCIN SULFATE

Drug Class

Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for NEOMYCIN SULFATE

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NEOMYCIN SULFATE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

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

R02AB	Antibiotics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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 NEOMYCIN SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	STATROL	neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	050344-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	NEOSPORIN	neomycin sulfate; polymyxin b sulfate	CREAM;TOPICAL	050176-002	Jan 14, 1985		DISCN	No	No
Pfizer	NEOBIOTIC	neomycin sulfate	TABLET;ORAL	060475-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Monarch Pharms	NEOSPORIN G.U. IRRIGANT	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	060707-001	Approved Prior to Jan 1, 1982	AT	RX	No	Yes
Teva	NEOMYCIN SULFATE	neomycin sulfate	TABLET;ORAL	060304-001	Approved Prior to Jan 1, 1982	AA	RX	No	Yes
Merck	NEO-HYDELTRASOL	neomycin sulfate; prednisolone sodium phosphate	OINTMENT;OPHTHALMIC	050378-001	Approved Prior to Jan 1, 1982		DISCN	No	No

NEOMYCIN SULFATE Market Analysis and Financial Projection Experimental

Neomycin Sulfate Market Dynamics and Financial Trajectory

Market Overview

Neomycin sulfate, an aminoglycoside antibiotic, is a crucial medication in the pharmaceutical landscape, widely used to treat various bacterial infections, particularly those caused by gram-negative bacteria. The market for neomycin sulfate is experiencing significant growth, driven by several key factors.

Current Market Size and Growth Projections

The neomycin sulfate market was valued at USD 1.23 billion in 2023 and is projected to reach USD 3.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.5% from 2024 to 2031[1].

Key Drivers of Market Growth

Rising Demand for Antibiotics

The increasing incidence of bacterial infections, especially skin and eye infections, is a major driver of the neomycin sulfate market. The drug's broad-spectrum antibiotic efficacy makes it a staple in many topical formulations such as eye drops, ointments, and creams[1][2].

Surgical Procedures and Infection Control

The rise in surgical procedures globally has significantly contributed to the demand for neomycin sulfate. It is commonly used as a prophylactic antibiotic to prevent postoperative infections, a critical aspect of infection control in clinical settings[2].

Veterinary Medicine

Neomycin sulfate's application in veterinary care, treating infections in livestock and pets, has opened new avenues for market growth. As the global demand for meat and dairy products increases, the need for effective veterinary antibiotics is expected to rise[2].

Emerging Markets and Healthcare Infrastructure

Rapid growth in healthcare infrastructure in emerging markets, coupled with rising awareness of antibiotic treatments and increasing disposable income, is driving demand for neomycin sulfate. This trend is anticipated to accelerate the market's growth trajectory[1][2].

Price Trends and Market Dynamics

Global Price Surges

In January 2024, global neomycin sulfate prices experienced a notable upward trajectory due to geopolitical tensions, dwindling supplies, logistical challenges, and depleting inventories. Seasonal factors like winter-related illnesses further exacerbated supply-demand imbalances, contributing to the price surge[3].

Regional Variations

• North America: The market is experiencing a decline in spot rates and a significant decrease in demand from the pharmaceutical and healthcare sectors, leading to an oversupply scenario and downward pressure on prices[4].
• Europe: The first quarter of 2023 saw a consistent rise in neomycin sulfate prices due to positive demand from downstream industries. However, the second quarter witnessed a decline in prices due to increased inflation and energy costs[4].
• Asia: The market in Asia, particularly in China, saw a rebound in neomycin sulfate prices after a slump in the third quarter of 2023. The recent surge in China's manufacturing sector has had a ripple effect on global prices[5].

Impact of Supply Chain and Logistics

Disruptions in global supply chains, such as constraints on shipments through the Suez Canal and potential bottlenecks in the Mississippi River, have led to increased shipping and operational expenses, contributing to higher prices[3][5].

Future Trends and Investment Opportunities

Innovations in Formulations

The development of new formulations and delivery systems for neomycin sulfate presents significant investment opportunities. Companies involved in such research and development are likely to see substantial returns[2].

Regulatory Approvals and Strategic Partnerships

Recent trends include innovations in formulations, regulatory approvals for new markets, and strategic partnerships for combination therapies. These factors are expected to drive market growth and present opportunities for investors[2].

Challenges and Mitigation Strategies

Despite the promising outlook, the neomycin sulfate market faces challenges such as antibiotic resistance and regulatory hurdles. Addressing these challenges through ongoing research and development is crucial for maintaining market growth[2].

Financial Trajectory

The financial trajectory of the neomycin sulfate market is robust, with a projected CAGR of 10.5% from 2024 to 2031. The market's growth is supported by increasing demand from both human and veterinary medicine, as well as expanding healthcare infrastructure in emerging markets.

Key Takeaways

• The neomycin sulfate market is expected to grow significantly, driven by rising demand for antibiotics and increasing awareness of infectious diseases.
• The market is influenced by various regional dynamics, including supply chain disruptions and logistical challenges.
• Innovations in formulations and strategic partnerships are key drivers of future growth.
• Challenges such as antibiotic resistance and regulatory hurdles need to be addressed through ongoing research and development.

FAQs

Q: What is the current market size of neomycin sulfate? A: The neomycin sulfate market was valued at USD 1.23 billion in 2023[1].

Q: What is the projected growth rate of the neomycin sulfate market? A: The market is expected to grow at a CAGR of 10.5% from 2024 to 2031[1].

Q: What are the primary drivers of the neomycin sulfate market? A: Key drivers include rising demand for antibiotics, increasing surgical procedures, and growing demand in veterinary medicine[1][2].

Q: How do regional variations affect neomycin sulfate prices? A: Prices vary by region due to factors such as supply-demand imbalances, logistical challenges, and regional economic conditions[3][4][5].

Q: What challenges does the neomycin sulfate market face? A: The market faces challenges such as antibiotic resistance and regulatory hurdles, which require ongoing research and development to mitigate[2].

Cited Sources:

1. Market Research Intellect - Neomycin Sulfate Market Size, Share & Trends [2031][1]
2. Market Research Intellect - Neomycin Sulfate Market on the Rise Key Drivers and Future Trends[2]
3. ChemAnalyst - Global Neomycin Sulphate Prices Surge in January Amidst Complex Market Dynamics[3]
4. Procurement Resource - Neomycin Sulphate Price Trend and Forecast[4]
5. ChemAnalyst - Neomycin Sulphate Prices Surge in USA and Germany Amidst Rising End-User Industry Demand[5]