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Last Updated: December 23, 2024

TERRAMYCIN-POLYMYXIN Drug Patent Profile


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Which patents cover Terramycin-polymyxin, and what generic alternatives are available?

Terramycin-polymyxin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in TERRAMYCIN-POLYMYXIN is oxytetracycline hydrochloride; polymyxin b sulfate. There are thirty-six drug master file entries for this compound. Additional details are available on the oxytetracycline hydrochloride; polymyxin b sulfate profile page.

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Summary for TERRAMYCIN-POLYMYXIN
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:TERRAMYCIN-POLYMYXIN at DailyMed
Drug patent expirations by year for TERRAMYCIN-POLYMYXIN

US Patents and Regulatory Information for TERRAMYCIN-POLYMYXIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TERRAMYCIN-POLYMYXIN oxytetracycline hydrochloride; polymyxin b sulfate TABLET;VAGINAL 061009-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TERRAMYCIN-POLYMYXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TERRAMYCIN-POLYMYXIN

Introduction

TERRAMYCIN with Polymyxin B is a widely used antibiotic combination, particularly effective against a broad spectrum of bacteria, including gram-positive and gram-negative organisms. This article delves into the market dynamics and financial trajectory of this drug, focusing on its usage, sales trends, and the broader context of antibiotic markets.

Therapeutic Indications and Usage

TERRAMYCIN with Polymyxin B is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea. It is effective against susceptible strains of various bacteria, including staphylococci, streptococci, pneumococci, and Pseudomonas aeruginosa[5].

Market Context: Antibiotic Sales Trends

The market for veterinary and human antibiotics is complex and influenced by various factors, including regulatory policies, resistance patterns, and economic considerations.

Overall Antibiotic Sales

In the European context, the sales of antibiotic veterinary medicinal products (VMPs) for food-producing animals have been declining. Between 2011 and 2022, aggregated sales in 25 European countries decreased by 53.0%, from 161.2 mg/PCU to 75.8 mg/PCU[4].

Specific Antibiotic Classes

The sales trends for specific antibiotic classes are varied:

  • Penicillins, Tetracyclines, and Sulfonamides: These classes dominate the market, accounting for a significant portion of total sales. In 2022, penicillins, tetracyclines, and sulfonamides accounted for 32.7%, 23.5%, and 9.4% of total sales, respectively[4].
  • Polymyxins: Sales of polymyxins have been relatively low and declining. Between 2011 and 2022, polymyxin sales decreased by 81.0%, from 11.0 mg/PCU to 2.1 mg/PCU[4].

Sales Dynamics of TERRAMYCIN-POLYMYXIN

Product Form and Usage

TERRAMYCIN with Polymyxin B is primarily used as an ophthalmic ointment. The product contains oxytetracycline hydrochloride and polymyxin B sulfate, which are effective against a wide range of bacterial infections. The ointment is administered topically, and its usage is generally stable due to its specific therapeutic indications[5].

Market Size and Growth

While the overall antibiotic market is declining, the specific market for ophthalmic antibiotics like TERRAMYCIN with Polymyxin B may remain relatively stable due to its niche application. However, the broader trend of reduced antibiotic usage could impact sales.

Economic Considerations

The economics of antibiotic drug development and sales are challenging. The cost of drug development is high, and the market size is influenced by the prevalence of the disease and the antimicrobial spectrum of the drug. Broad-spectrum antibiotics, while more marketable, face the risk of shortened useful life due to drug resistance[3].

Financial Trajectory

Revenue Trends

Given the declining overall sales of antibiotics, the revenue from TERRAMYCIN with Polymyxin B might also be affected. However, its specific use in ophthalmic infections could mitigate some of this impact.

Cost and Pricing

The cost of producing TERRAMYCIN with Polymyxin B, including the active ingredients oxytetracycline and polymyxin B, influences its pricing. The combination of these two antibiotics in a single product adds value but also increases production costs. Pricing strategies must balance profitability with the need to maintain market share in a competitive environment[5].

Regulatory Impact

Regulatory policies aimed at reducing antibiotic resistance can significantly impact sales. For instance, the European Medicines Agency (EMA) and national authorities have implemented measures to restrict the use of certain antibiotic classes, which can affect the financial trajectory of antibiotic products[4].

Competitive Landscape

The market for ophthalmic antibiotics is competitive, with several products available for treating similar infections. TERRAMYCIN with Polymyxin B competes with other ophthalmic preparations, and its market share is influenced by factors such as efficacy, safety profile, and pricing.

Challenges and Opportunities

Antibiotic Resistance

One of the major challenges facing TERRAMYCIN with Polymyxin B is the issue of antibiotic resistance. The emergence of resistant strains can reduce the effectiveness of the drug and impact its sales. However, this also presents opportunities for developing new formulations or combinations that can overcome resistance[3].

Regulatory Compliance

Compliance with regulatory guidelines is crucial. The EMA's AMEG categories, which classify antibiotics based on their importance in human medicine, influence the use and sales of veterinary antibiotics. Adhering to these guidelines can help maintain market access and stability[4].

Key Takeaways

  • Declining Antibiotic Sales: Overall sales of antibiotics for food-producing animals are declining, influenced by regulatory policies and resistance concerns.
  • Stable Niche Market: TERRAMYCIN with Polymyxin B, used for ophthalmic infections, may experience relatively stable sales due to its specific application.
  • Economic Challenges: High development costs and the risk of resistance shorten the useful life of broad-spectrum antibiotics.
  • Regulatory Impact: Compliance with regulatory guidelines is essential for maintaining market share.
  • Competitive Landscape: The ophthalmic antibiotic market is competitive, with pricing and efficacy being key differentiators.

FAQs

What is TERRAMYCIN with Polymyxin B used for?

TERRAMYCIN with Polymyxin B is used for the treatment of superficial ocular infections involving the conjunctiva and/or cornea.

How is TERRAMYCIN with Polymyxin B administered?

It is administered topically as an ophthalmic ointment, applied into the conjunctival sac of the lower lid 4 to 6 times daily.

What are the active ingredients in TERRAMYCIN with Polymyxin B?

The active ingredients are oxytetracycline hydrochloride and polymyxin B sulfate.

Why are antibiotic sales declining?

Antibiotic sales are declining due to regulatory policies aimed at reducing antibiotic resistance and the emergence of resistant bacterial strains.

How does antibiotic resistance impact TERRAMYCIN with Polymyxin B?

Antibiotic resistance can reduce the effectiveness of TERRAMYCIN with Polymyxin B, impacting its sales and necessitating the development of new formulations or combinations.

Sources

  1. EMA - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals
  2. Pfizer - Terramycin Ophthalmic Ointment
  3. NCBI Bookshelf - Antibiotic Resistance
  4. EMA - Sales of veterinary antimicrobial agents in 31 European countries
  5. Drugs.com - Terramycin with Polymyxin B: Package Insert / Prescribing Info

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