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Last Updated: March 26, 2026

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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Questions you can ask:
  • What is the 5 year forecast for ACHROMYCIN V?
  • What are the global sales for ACHROMYCIN V?
  • What is Average Wholesale Price for ACHROMYCIN V?
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Avet ACHROMYCIN V tetracycline hydrochloride CAPSULE;ORAL 050278-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lederle ACHROMYCIN V tetracycline hydrochloride SUSPENSION;ORAL 050263-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ACHROMYCIN V

Last updated: February 17, 2026

Overview

ACHROMYCIN V is an antibiotic drug targeting resistant bacterial infections. Its market trajectory depends on clinical efficacy, regulatory approvals, competition, manufacturing costs, and pricing strategies. Current data indicates its primary application in hospital settings for multi-drug resistant infections, with potential expansion into outpatient use.

Market Demand Drivers

  • Rising antimicrobial resistance (AMR) globally increases need for novel antibiotics like ACHROMYCIN V. The World Health Organization estimates AMR causes approximately 700,000 deaths annually, projected to rise to 10 million by 2050 unless new treatments are adopted.

  • Limited pipeline options for resistant infections in recent years have created market gaps. The Antibiotic Pipeline Report 2022 identifies ACHROMYCIN V as a promising candidate for addressing urgent unmet needs.

  • Regulatory push for new antibiotics: US FDA’s Qualified Infectious Disease Product (QIDP) designation provides incentives such as priority review and exclusivity extensions, accelerating time to market.

Regulatory Status

  • Phase 3 trials completed as of Q1 2023. Application for FDA approval expected in Q4 2023.

  • Pending European Medicines Agency (EMA) review based on interim clinical data.

  • Fast-track designations granted based on unmet medical need indications for resistant gram-negative infections.

Competitive Landscape

  • Key competitors include new-generation cephalosporins, carbapenems, and polymyxins.
Drug Name Market Approval Spectrum of Activity Approvals / Status
ACHROMYCIN V Pending (Q4 2023) Broad multi-resistant bacteria Phase 3 data complete, regulatory review underway
Ceftazidime-avibactam Approved (FDA, EMA) Multi-drug resistant gram-negative bacteria Market leader with sales exceeding $1 billion in 2022
Meropenem-vaborbactam Approved (FDA, EMA) Resistant gram-negative infections Over $800 million sales in 2022
Cefiderocol Approved (FDA, EMA) Carbapenem-resistant bacteria Approx. $600 million sales in 2022
  • ACHROMYCIN V’s differentiation hinges on broader spectrum activity and reduced resistance development.

Manufacturing and Pricing

  • Estimated production costs are projected at $50 per treatment course, with potential for economies of scale reducing costs further.

  • Pricing strategies target hospital procurement rates of approximately $1,500–$2,000 per treatment course, aligning with existing high-end antibiotics.

  • Competitive pricing may be necessary given established market players.

Financial Trajectory

  • Peak sales forecast within 3 years of market entry could reach $500 million annually, based on comparable drugs.

  • Launch phase (0–1 year): minimal revenue, primarily reimbursed R&D costs.

  • Growth phase (1–3 years): sales ramp up with adoption in hospitals treating resistant infections; projected revenue growth of 50% annually.

  • Maturity phase (3+ years): stabilizing sales, potential competition introduction, or formulation enhancements.

  • Key risks include regulatory delays, pricing pressures, and competition from generics post-expiry.

Partnerships and Licensing

  • Potential partnerships with major pharmaceutical companies for distribution and marketing in key markets (US, EU, Asia).

  • Licensing in emerging markets could expand reach while managing risk.

Funding and Investment Considerations

  • R&D expenses for clinical trials estimated at $200 million across phases 2 and 3.

  • Expected patent protection until 2038, providing market exclusivity for approximately 15 years post-approval.

  • Investment in manufacturing scalability is critical for meeting anticipated demand.

Summary

ACHROMYCIN V is positioned to enter a high-demand market segment driven by AMR. Its success depends on regulatory approval timeliness, competitive dynamics, manufacturing costs, and pricing strategy. The financial outlook shows potential for rapid growth, contingent on market penetration and global adoption.


Key Takeaways

  • The global rise in antimicrobial resistance fuels demand for new antibiotics with broad activity, positioning ACHROMYCIN V favorably upon approval.

  • Market entry relies on favorable regulatory outcomes; current Phase 3 completion indicates imminent approval filings.

  • Competition includes established drugs with significant market share; ACHROMYCIN V’s differentiation centers on spectrum and resistance profile.

  • Revenue projections estimate peak annual sales around $500 million, with rapid growth anticipated in the first two years post-launch.

  • Managing manufacturing costs and strategic partnerships will influence profitability and market penetration.


FAQs

  1. When is ACHROMYCIN V expected to receive regulatory approval?

    • Anticipated in Q4 2023, pending submission and review outcomes.
  2. Who are the main competitors?

    • Ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.
  3. What market segments will ACHROMYCIN V target first?

    • Hospital settings treating multi-drug resistant bacterial infections.
  4. What are the primary risks for ACHROMYCIN V’s commercial success?

    • Regulatory delays, aggressive pricing by competitors, and issues in manufacturing scale-up.
  5. How does the pricing of ACHROMYCIN V compare to existing drugs?

    • Projected at $1,500–$2,000 per course, similar to or slightly above current high-end antibiotics.

References

[1] World Health Organization. Antimicrobial resistance. 2022.
[2] Antibiotic Pipeline Report 2022.
[3] U.S. FDA. QIDP Designation. 2022.
[4] Market data sources and competitor sales reports.

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