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Last Updated: March 26, 2025

Oxytetracycline calcium - Generic Drug Details


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What are the generic drug sources for oxytetracycline calcium and what is the scope of patent protection?

Oxytetracycline calcium is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for oxytetracycline calcium.

Summary for oxytetracycline calcium
Recent Clinical Trials for oxytetracycline calcium

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all oxytetracycline calcium clinical trials

US Patents and Regulatory Information for oxytetracycline calcium

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pfizer TERRAMYCIN oxytetracycline calcium SYRUP;ORAL 060595-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Oxytetracycline Calcium

Market Overview

Oxytetracycline calcium, a derivative of the tetracycline antibiotic oxytetracycline, is a significant player in the pharmaceutical and veterinary markets. Here’s a detailed look at its market dynamics and financial trajectory.

Global Market Size and Growth

The global oxytetracycline calcium market has been experiencing steady growth. As of 2023, the market size was valued at approximately USD 1 billion. It is projected to reach USD 1.5 billion by 2032, indicating a robust growth trajectory over the next decade[1].

Regional Market Performance

North America

The North American market for oxytetracycline calcium premix is expected to grow significantly from 2023 to 2030, driven by increasing demand in veterinary and agricultural sectors. This region is anticipated to see a notable Compound Annual Growth Rate (CAGR) during this period[4].

Global Market

The global market for oxytetracycline calcium is subject to an exhaustive evaluation throughout the forecast period from 2023 to 2031. This scrutiny highlights the market's potential for growth, driven by its widespread use in human and animal health, as well as in agriculture[5].

Applications and Uses

Human Health

Oxytetracycline calcium is used to treat a wide variety of bacterial infections, including those caused by Gram-positive and Gram-negative microorganisms. It is effective against infections such as respiratory tract infections, urinary tract infections, and rare diseases like anthrax and plague[2][3].

Veterinary and Aquaculture

In the veterinary sector, oxytetracycline calcium is crucial for treating bacterial infections in animals. It is also used in aquaculture, particularly in fish hatcheries, to treat infections in fish and other aquatic species. This includes facilities culturing threatened and endangered fish species[2].

Agricultural Use

Oxytetracycline calcium is registered as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and is used to control bacterial diseases in crops. Tolerances for residues of oxytetracycline on raw peaches, nectarines, and pears are established by the U.S. Environmental Protection Agency (EPA)[2].

Regulatory Framework

The use of oxytetracycline calcium is regulated by several bodies:

  • U.S. Environmental Protection Agency (EPA): Regulates its use as a pesticide and sets tolerance levels for residues on crops.
  • U.S. Food and Drug Administration (FDA): Regulates its use as an oral and injectable prescription drug for human and veterinary purposes[2].

Mechanism of Action and Pharmacodynamics

Oxytetracycline calcium works by inhibiting bacterial protein synthesis. It binds to the 30S ribosomal subunit, preventing the amino-acyl tRNA from binding to the A site of the ribosome. This mechanism makes it effective against a broad spectrum of bacterial infections[3].

Safety and Toxicity

Studies have shown that oxytetracycline calcium is practically non-toxic to birds, fish, aquatic invertebrates, and non-target insects like honey bees. The EPA has classified it as a Toxicity Category IV pesticide, indicating the lowest level of acute toxicity. However, high doses have shown adverse effects in laboratory animals, and it is classified as a “Group D” carcinogen by the EPA, meaning it is not classifiable as to human carcinogenicity[2].

Market Drivers

  • Increasing Demand in Veterinary and Aquaculture: Growing need for effective antibiotics in animal health and aquaculture drives the demand for oxytetracycline calcium.
  • Agricultural Use: The use of oxytetracycline calcium in crop protection and as a pesticide contributes to its market growth.
  • Human Health: Continued use in treating bacterial infections in humans, especially in regions with limited access to newer antibiotics, sustains market demand[2][4].

Market Challenges

  • Antibiotic Resistance: The increasing resistance to tetracyclines among pathogens poses a significant challenge to the market.
  • Regulatory Scrutiny: Strict regulations and monitoring by agencies like the EPA and FDA can impact market dynamics.
  • Competition from Newer Antibiotics: The development and use of newer antibiotics could reduce the reliance on oxytetracycline calcium[2][3].

Financial Projections

The financial trajectory of oxytetracycline calcium is positive, with projected growth from USD 1 billion in 2023 to USD 1.5 billion by 2032. This growth is driven by its diverse applications and the increasing demand in various sectors.

Key Statistics

  • Market Size (2023): Approximately USD 1 billion[1].
  • Projected Market Size (2032): USD 1.5 billion[1].
  • CAGR (North America): Expected to be significant from 2023 to 2030[4].

Conclusion

The market for oxytetracycline calcium is poised for growth, driven by its broad-spectrum antimicrobial efficacy and diverse applications in human health, veterinary medicine, aquaculture, and agriculture. Despite challenges such as antibiotic resistance and regulatory scrutiny, the financial trajectory indicates a robust future for this antibiotic.

Key Takeaways

  • Market Growth: Projected to reach USD 1.5 billion by 2032.
  • Diverse Applications: Used in human health, veterinary medicine, aquaculture, and agriculture.
  • Regulatory Framework: Regulated by EPA and FDA.
  • Safety Profile: Classified as Toxicity Category IV pesticide.
  • Market Drivers: Increasing demand in veterinary and aquaculture, agricultural use, and human health needs.

FAQs

  1. What is oxytetracycline calcium used for?

    • Oxytetracycline calcium is used to treat a wide variety of bacterial infections in humans and animals, as well as in agricultural and aquaculture settings.
  2. How does oxytetracycline calcium work?

    • It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, preventing the amino-acyl tRNA from binding to the A site of the ribosome.
  3. Is oxytetracycline calcium safe for the environment?

    • It is practically non-toxic to birds, fish, aquatic invertebrates, and non-target insects like honey bees, and is classified as a Toxicity Category IV pesticide by the EPA.
  4. What are the regulatory bodies overseeing the use of oxytetracycline calcium?

    • The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) regulate its use.
  5. What are the market challenges for oxytetracycline calcium?

    • Increasing antibiotic resistance, regulatory scrutiny, and competition from newer antibiotics are significant challenges.

Sources:

  1. Dataintelo - Oxytetracycline Calcium Market Research Report 2032
  2. USDA - Tetracycline (Oxytetracycline Calcium Complex)
  3. DrugBank - Oxytetracycline: Uses, Interactions, Mechanism of Action
  4. Valuates Reports - Global Oxytetracycline Calcium Premix Market
  5. Market Research Intellect - Global Oxytetracycline Calcium Market Report

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