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Last Updated: December 22, 2024

ACHROMYCIN V Drug Patent Profile


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Which patents cover Achromycin V, and when can generic versions of Achromycin V launch?

Achromycin V is a drug marketed by Avet and Lederle and is included in two NDAs.

The generic ingredient in ACHROMYCIN V is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Achromycin V

A generic version of ACHROMYCIN V was approved as tetracycline hydrochloride by WATSON LABS on December 31st, 1969.

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Summary for ACHROMYCIN V
Drug patent expirations by year for ACHROMYCIN V
Pharmacology for ACHROMYCIN V

US Patents and Regulatory Information for ACHROMYCIN V

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avet ACHROMYCIN V tetracycline hydrochloride CAPSULE;ORAL 050278-003 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Avet ACHROMYCIN V tetracycline hydrochloride CAPSULE;ORAL 050278-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle ACHROMYCIN V tetracycline hydrochloride SUSPENSION;ORAL 050263-002 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

ACHROMYCIN V Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Achromycin V

Introduction

Achromycin V, a tetracycline antibiotic, is widely used to treat various bacterial infections. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals. Here, we delve into the key aspects of Achromycin V's market performance, financial metrics, and the broader context of the antibiotic market.

Market Context of Antibiotics

The antibiotic market is dominated by generic, off-patent products, which are low-priced and effective for most infections. This dominance is reflected in the top-selling antibiotics list, where generic antibiotics like amoxicillin, vancomycin, and penicillin G lead in terms of annual revenue[3].

Achromycin V: Product Overview

Achromycin V (tetracycline HCl) is indicated for treating a variety of bacterial infections, including severe acne, brucellosis, syphilis, and gonorrhea. It is available in capsule form and has specific dosage recommendations for adults and children[4][5].

Sales and Revenue

Given that Achromycin V is a generic antibiotic, its sales and revenue are typically lower compared to newer, branded antibiotics. The average global annual revenue for new antibiotic drugs launched between 2010 and 2020 was estimated to be around $46 million. However, generic antibiotics like Achromycin V usually generate less revenue due to their lower pricing and widespread availability[3].

Competitive Landscape

The competitive landscape for antibiotics is highly saturated with generic products. Achromycin V competes with other tetracycline antibiotics and broader classes of antibiotics. The top-selling antibiotics in the U.S. market are mostly generics, with Achromycin V not being among the top sellers due to its niche use and generic status[3].

Development and Approval Costs

The development and approval costs for antibiotics, including those like Achromycin V, are significant but generally lower than those for other therapeutic areas like oncology. A study on antimicrobial drugs found that the average capitalized development and approval costs for antimicrobial drugs were approximately $1.508 billion, which is less than the costs for non-antimicrobial comparators and oncology drugs[1].

Market Performance Metrics

Comparative Added Clinical Benefit

Market performance of antibiotics is often linked to their comparative added clinical benefit. Studies have shown that drugs with higher overall comparative added clinical benefit scores tend to have higher early market sales. However, for antibiotics like Achromycin V, the sales are generally modest due to their generic status and the prevalence of other effective antibiotics[1].

Sales Figures

The sales figures for Achromycin V are not as high as those for branded antibiotics or other therapeutic areas. For instance, the average cumulative 9-quarter sales for the highest-ranking antimicrobial drugs are around $42 million, significantly lower than the $1.041 billion for oncology drugs[1].

Financial Incentives and Challenges

Pull Incentives

To encourage the development of new antibiotics, pull incentives such as yearly rewards during the ten years following approval are proposed. For example, a yearly pull incentive of $260 million could amount to a total reward of approximately $2.6 billion over ten years. This is crucial because the current market conditions often do not provide sufficient financial returns to justify the high development costs of new antibiotics[3].

Cost-Benefit Analysis

Cost-benefit analyses, such as those conducted for vancomycin dosing strategies, highlight the importance of efficient dosing methods to reduce costs and improve clinical outcomes. While Achromycin V does not feature in such specific analyses, the broader principle of optimizing antibiotic use to reduce healthcare costs is relevant[2].

Regulatory and Clinical Considerations

Safety and Efficacy

Achromycin V, like other tetracyclines, has specific safety and efficacy profiles. It can cause side effects such as gastrointestinal issues, teeth discoloration, and potential liver failure in pregnant women with renal disease. These considerations affect its market acceptance and usage[4][5].

Dosage and Administration

The dosage and administration guidelines for Achromycin V are critical for its effective use. The drug is usually administered in specific doses for different infections, and its use must be carefully managed to avoid adverse effects[4].

Key Takeaways

  • Market Dominance by Generics: The antibiotic market is largely dominated by generic, off-patent products.
  • Modest Revenue: Achromycin V, as a generic antibiotic, generates modest revenue compared to branded antibiotics.
  • Development Costs: The development and approval costs for antibiotics are significant but generally lower than those for other therapeutic areas.
  • Pull Incentives: Financial incentives are necessary to encourage the development of new antibiotics due to the modest market returns.
  • Clinical Considerations: Safety, efficacy, and proper dosage administration are crucial for the effective use of Achromycin V.

FAQs

What is Achromycin V used for?

Achromycin V (tetracycline HCl) is used to treat various bacterial infections, including severe acne, brucellosis, syphilis, and gonorrhea.

How does Achromycin V compare to other antibiotics in terms of sales?

Achromycin V, being a generic antibiotic, typically generates lower sales revenue compared to branded antibiotics and other therapeutic areas like oncology.

What are the main side effects of Achromycin V?

Common side effects include gastrointestinal issues, teeth discoloration, and potential liver failure in pregnant women with renal disease.

Why are pull incentives necessary for antibiotic development?

Pull incentives are necessary because the current market conditions often do not provide sufficient financial returns to justify the high development costs of new antibiotics.

How do development costs for antibiotics compare to other therapeutic areas?

The development and approval costs for antibiotics are generally lower than those for other therapeutic areas, such as oncology, but still significant.

Sources

  1. ASPE: Antimicrobial Drugs Market Returns Analysis Final Report, December 16, 2022.
  2. PubMed: Cost-benefit analysis comparing trough, two-level AUC strategies versus trough-guided dosing, November 19, 2020.
  3. Harvard Kennedy School: Sizing A Market Entry Reward for the Development of New Antibiotics.
  4. Drugs.com: Achromycin V: Package Insert / Prescribing Information.
  5. RxList: Achromycin V (tetracycline): Side Effects, Uses, Dosage.

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