Last Updated: April 30, 2026

CAPREOMYCIN SULFATE Drug Patent Profile


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When do Capreomycin Sulfate patents expire, and when can generic versions of Capreomycin Sulfate launch?

Capreomycin Sulfate is a drug marketed by Hisun Pharm Hangzhou and Pharmobedient and is included in two NDAs.

The generic ingredient in CAPREOMYCIN SULFATE is capreomycin sulfate. There are three drug master file entries for this compound. Additional details are available on the capreomycin sulfate profile page.

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  • What is the 5 year forecast for CAPREOMYCIN SULFATE?
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Summary for CAPREOMYCIN SULFATE
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 8
Clinical Trials: 1
DailyMed Link:CAPREOMYCIN SULFATE at DailyMed
Recent Clinical Trials for CAPREOMYCIN SULFATE

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SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)N/A

See all CAPREOMYCIN SULFATE clinical trials

Medical Subject Heading (MeSH) Categories for CAPREOMYCIN SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for CAPREOMYCIN SULFATE

US Patents and Regulatory Information for CAPREOMYCIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hisun Pharm Hangzhou CAPREOMYCIN SULFATE capreomycin sulfate INJECTABLE;INJECTION 204796-001 Oct 18, 2018 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient CAPREOMYCIN SULFATE capreomycin sulfate INJECTABLE;INJECTION 202634-001 Nov 27, 2017 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

CAPREOMYCIN SULFATE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Current Market Dynamics for Capreomycin Sulfate?

Capreomycin sulfate is an injectable antibiotic primarily used to treat multi-drug resistant tuberculosis (MDR-TB). Its market is influenced by TB prevalence, drug resistance patterns, and the development of new treatment regimens.

Market Size and Demand Drivers

  • The global tuberculosis (TB) market was valued at approximately $10 billion in 2021, with MDR-TB accounting for roughly 3.4% of new TB cases worldwide.[1]
  • Capreomycin’s utilization depends on MDR-TB prevalence. In 2021, WHO estimated there were 450,000 new cases of MDR-TB globally.[2]
  • The clinical preference for capreomycin is influenced by resistance profiles. It is often used when first-line drugs fail or are contraindicated.

Treatment Landscape and Competition

  • Capreomycin competes with other injectable agents like amikacin and kanamycin.
  • Recent advances in shorter, all-oral MDR-TB regimens reduce reliance on injectable agents, impacting demand.
  • Johnson & Johnson’s Bedaquiline and Merck’s Pretomanid have been approved for MDR-TB, offering oral alternatives.[3]

Regulatory and Policy Impact

  • WHO recommends capreomycin within specific individualized regimens for MDR-TB.
  • Many countries have shifted policies toward oral drugs, limiting the long-term market for injectable agents.

Supply Chain and Manufacturing Considerations

  • Few manufacturers produce capreomycin sulfate, mainly Indian and Chinese pharmaceutical companies.
  • Export regulations, some governments’ procurement policies, and manufacturing capacity influence supply dynamics.

What Is the Financial Trajectory for Capreomycin Sulfate?

Revenue Outlook

  • The market for capreomycin sulfate has been relatively stable but faces pressure from new oral MDR-TB treatments.
  • Estimated global sales in 2022 ranged between $150 million to $200 million, reflecting its niche status.[4]
  • Potential growth hinges on the emergence of resistance to oral drugs and the continuation of MDR-TB cases.

Pricing Trends

  • Prices vary across regions; the drug costs approximately $10 to $50 per vial, depending on batch size and supply agreements.
  • Competition and generic manufacturing could further reduce prices, affecting profit margins.

R&D and Investment Trends

  • Limited R&D investments are directed explicitly at capreomycin; most effort centers around developing new drugs or regimens.
  • The global priority on oral drugs for MDR-TB diminishes prospects for future innovation specifically targeting injectable agents.

Market Entry Barriers and Opportunities

  • Barriers include high manufacturing costs, regulatory hurdles, and declining demand due to alternative treatments.
  • Opportunities exist in niche markets where resistance to newer oral drugs has not developed.
  • Partnership opportunities with global health initiatives like the Stop TB Partnership could influence future supply and demand.

Summary of Market & Financial Trends

Aspect Key Data Impact
Market size $10 billion TB market, $150–200 million for capreomycin (2022) Niche but critical for MDR-TB, declining due to oral drug options
Demand drivers MDR-TB prevalence, resistance patterns Stabilizing or decreasing demand in regions shifting to oral regimens
Competition Amikacin, kanamycin, oral drugs Increasing competition reduces market share for capreomycin
Pricing $10–$50 per vial Price erosion possible with generics and volume-based procurement
R&D focus Minimal specific to capreomycin Limited prospects for innovation or growth

Key Takeaways

  • The global market for capreomycin sulfate remains limited to MDR-TB cases where oral options are unsuitable or resistance has developed.
  • Demand growth is unlikely due to shifting policies favoring oral agents and evolving treatment guidelines.
  • The financial outlook is characterized by stable or declining revenues, with price pressures from generic manufacturing.
  • Supply can be affected by regulatory environments, manufacturing capacity, and global procurement policies.
  • Investment and R&D efforts are predominantly outside of the capreomycin pipeline, focusing instead on oral and combination therapies.

FAQs

1. Will the market for capreomycin sulfate expand in the coming years?
No. Increased adoption of oral MDR-TB treatments is reducing reliance on injectable agents like capreomycin.

2. What factors most affect capreomycin sulfate's market share?
Regulatory policies promoting oral drugs and emerging resistance to injectable agents influence its market share.

3. Are there new formulations of capreomycin sulfate in development?
No significant new formulations are underway. Most R&D focuses on novel oral therapies.

4. How does resistance evolution impact capreomycin's usage?
Rising resistance to capreomycin could further restrict its use to specific cases, diminishing demand.

5. What are the key regions for capreomycin sulfate demand?
High-burden TB countries like India, China, and parts of Africa remain primary regions, though oral drug adoption is increasing there as well.


Sources

[1] WHO, Global Tuberculosis Report 2022
[2] WHO, MDR-TB prevalence estimates 2021
[3] FDA, Drug Approvals for MDR-TB 2022
[4] MarketLine, Pharmaceutical Market Data 2022

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