Bacitracin zinc; polymyxin b sulfate - Generic Drug Details

What are the generic sources for bacitracin zinc; polymyxin b sulfate and what is the scope of freedom to operate?

Bacitracin zinc; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Bausch And Lomb, Padagis Us, Sciegen Pharms Inc, Pharmafair, Monarch Pharms, and Naska, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for bacitracin zinc; polymyxin b sulfate

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	7
Clinical Trials:	1
DailyMed Link:	bacitracin zinc; polymyxin b sulfate at DailyMed

Recent Clinical Trials for bacitracin zinc; polymyxin b sulfate

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	N/A
Glaxo Wellcome	N/A

See all bacitracin zinc; polymyxin b sulfate clinical trials

Pharmacology for bacitracin zinc; polymyxin b sulfate

Drug Class	Polymyxin-class Antibacterial
Physiological Effect	Decreased Cell Wall Synthesis & Repair

Anatomical Therapeutic Chemical (ATC) Classes for bacitracin zinc; polymyxin b sulfate

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

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01XB	Polymyxins
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XX	Other antibacterials
J01X	OTHER 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

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 bacitracin zinc; polymyxin b sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms Inc	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064028-001	Jan 30, 1995		DISCN	No	No
Pharmafair	OCUMYCIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	062430-001	Apr 8, 1983		DISCN	No	No
Glaxosmithkline	POLYSPORIN	bacitracin zinc; polymyxin b sulfate	AEROSOL;TOPICAL	050167-002	Mar 1, 1985		DISCN	No	No
Naska	BACITRACIN ZINC-POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;TOPICAL	062849-001	Nov 13, 1987		DISCN	No	No
Padagis Us	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	065022-001	Feb 27, 2002	AT	RX	No	No
Monarch Pharms	POLYSPORIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	061229-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Bacitracin zinc; polymyxin b sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bacitracin Zinc and Polymyxin B Sulfate

Introduction

Bacitracin zinc and polymyxin B sulfate are widely used antibiotics in various medical and veterinary applications. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical Context and Approval

Bacitracin zinc and polymyxin B sulfate have been in use for several decades. The first approval for a combination ointment containing these antibiotics was granted in the US on May 10, 1971[2].

Therapeutic Uses

These antibiotics are primarily used for the topical treatment of superficial infections, particularly of the external eye and its adnexa, including conditions such as conjunctivitis, keratitis, and blepharitis. They are also used in veterinary medicine for similar indications in dogs and cats[2][4].

Mechanism of Action

Bacitracin zinc inhibits bacterial cell wall synthesis, while polymyxin B sulfate increases the permeability of the bacterial cell membrane, making them effective against a wide range of gram-positive and gram-negative organisms[2].

Market Demand

The demand for these antibiotics is driven by their efficacy in treating common bacterial infections. The ophthalmic ointment formulation is particularly popular due to its broad-spectrum antibacterial activity and ease of application.

Competitive Landscape

The market for bacitracin zinc and polymyxin B sulfate is competitive, with several pharmaceutical companies manufacturing and distributing these products. Akorn, Inc., for example, launched an Abbreviated New Animal Drug Application (ANADA) for Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment in 2020, addressing a market shortage in veterinary ophthalmics[4].

Financial Performance

The financial performance of these drugs is influenced by several factors, including production costs, market demand, and regulatory approvals. Here are some key points:

Production Costs

The production of bacitracin zinc and polymyxin B sulfate involves the cultivation of specific bacteria (Bacillus subtilis var Tracy for bacitracin and Bacillus polymyxa for polymyxin B). The costs associated with fermentation, purification, and formulation can impact the overall profitability of these products[2][5].

Market Demand and Pricing

The pricing of these antibiotics is generally stable due to their long-standing presence in the market. However, fluctuations in demand, particularly in the veterinary sector, can influence pricing strategies. For instance, the launch of Akorn’s ANADA for veterinary use helped stabilize prices by addressing a market shortage[4].

Regulatory Approvals

Regulatory approvals play a crucial role in the financial trajectory of these drugs. New approvals, such as Akorn’s ANADA, can open up new revenue streams and expand market share. Conversely, regulatory challenges or changes in approval status can negatively impact financial performance[4].

Market Trends

Increasing Resistance

The rise of antibiotic resistance is a significant trend affecting the market for bacitracin zinc and polymyxin B sulfate. As bacteria become more resistant, the effectiveness of these antibiotics may decrease, leading to a potential decline in demand and revenue[2].

Veterinary Market

The veterinary market is a growing segment for these antibiotics. The launch of products like Akorn’s ANADA highlights the increasing demand for approved ophthalmic antibiotics in veterinary care[4].

Generic and Specialty Pharmaceuticals

The market is dominated by generic pharmaceutical companies, which often have lower production costs and can offer competitive pricing. However, specialty pharmaceutical companies also play a role, particularly in niche markets such as veterinary ophthalmics[4].

Clinical Efficacy and Safety

Clinical Studies

Studies have shown that the combination of bacitracin zinc and polymyxin B sulfate is highly effective in reducing wound infection rates compared to other topical agents. For example, a prospective study found that this combination had one of the lowest wound infection rates among the treatments evaluated[3].

Safety Profile

The safety profile of these antibiotics is generally favorable, although prolonged use can lead to overgrowth of nonsusceptible organisms, including fungi. There are also concerns regarding potential teratogenic effects and the impact on fertility, although these have not been extensively studied[2].

Future Outlook

Innovations and Formulations

Future innovations may focus on improving the stability and efficacy of these antibiotics. For instance, the zinc complex in bacitracin zinc enhances its stability compared to bacitracin alone[5].

Regulatory Environment

Changes in regulatory environments, such as stricter guidelines on antibiotic use or new approval pathways, can significantly impact the market dynamics and financial trajectory of these drugs.

Global Health Initiatives

Global health initiatives aimed at reducing antibiotic resistance and promoting the responsible use of antibiotics will continue to shape the market for bacitracin zinc and polymyxin B sulfate.

Key Takeaways

• Historical Context: Bacitracin zinc and polymyxin B sulfate have been approved and in use since 1971.
• Therapeutic Uses: Primarily used for superficial infections of the external eye and its adnexa, as well as in veterinary medicine.
• Market Demand: Driven by efficacy and broad-spectrum antibacterial activity.
• Financial Performance: Influenced by production costs, market demand, and regulatory approvals.
• Market Trends: Increasing antibiotic resistance, growing veterinary market, and dominance by generic pharmaceutical companies.
• Clinical Efficacy and Safety: Highly effective in reducing infection rates, with a generally favorable safety profile.

FAQs

1. What are the primary therapeutic uses of bacitracin zinc and polymyxin B sulfate?

   • These antibiotics are primarily used for the topical treatment of superficial infections of the external eye and its adnexa, as well as in veterinary medicine for similar indications.

2. How do bacitracin zinc and polymyxin B sulfate work?

   • Bacitracin zinc inhibits bacterial cell wall synthesis, while polymyxin B sulfate increases the permeability of the bacterial cell membrane.

3. What are the key factors influencing the financial performance of these antibiotics?

   • Production costs, market demand, and regulatory approvals are crucial factors.

4. What is the impact of antibiotic resistance on the market for these drugs?

   • The rise of antibiotic resistance can decrease the effectiveness and demand for these antibiotics, potentially impacting revenue.

5. What are some future trends and innovations expected in this market?

   • Innovations in formulations, changes in regulatory environments, and global health initiatives aimed at reducing antibiotic resistance are expected to shape the market.

Sources

1. Synapse by Patsnap - Bacitracin Zinc/Neomycin sulfate/Polymycin B sulfate[1]
2. DailyMed - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment[2]
3. PubMed - Prospective evaluation of topical antibiotics for preventing infections[3]
4. BioSpace - Akorn Animal Health Announces Launch of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment[4]
5. Xellia Pharmaceuticals - Bacitracin zinc[5]