Last Updated: June 18, 2026

MIDOZALAM HYDROCHLORIDE Drug Patent Profile


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When do Midozalam Hydrochloride patents expire, and what generic alternatives are available?

Midozalam Hydrochloride is a drug marketed by Onesource Specialty and is included in one NDA.

The generic ingredient in MIDOZALAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Midozalam Hydrochloride

A generic version of MIDOZALAM HYDROCHLORIDE was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20th, 2000.

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  • What is the 5 year forecast for MIDOZALAM HYDROCHLORIDE?
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Summary for MIDOZALAM HYDROCHLORIDE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
DailyMed Link:MIDOZALAM HYDROCHLORIDE at DailyMed
Pharmacology for MIDOZALAM HYDROCHLORIDE
Drug ClassBenzodiazepine

US Patents and Regulatory Information for MIDOZALAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onesource Specialty MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316-001 May 4, 2011 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Onesource Specialty MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316-002 May 4, 2011 AP RX 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
Last updated: February 12, 2026

Market Dynamics for Midozalam Hydrochloride

Midozalam hydrochloride, a benzodiazepine derivative, is primarily used as an anesthetic agent for sedation, induction, and maintenance of anesthesia. It exhibits a rapid onset with short duration, making it suitable for specific clinical applications. The drug's market is influenced by regulatory status, clinical acceptance, competition, and the overall demand for anesthetic agents.

Regulatory and Clinical Landscape

Midozalam hydrochloride is not broadly marketed independently; instead, it exists within the broader benzodiazepine class, which faces regulatory scrutiny concerning dependency potential and abuse. Approval status varies globally, with some regions restricting or banning its use. It is used off-label in certain jurisdictions, which limits its commercial potential.

Competitive Position

The anesthetic market is dominated by agents such as midazolam, propofol, and ketamine. Midozalam hydrochloride competes primarily on the basis of rapid onset and short duration but struggles due to limited clinical adoption and regulatory hurdles. Its use is niche, mainly within specialized anesthesia centers or research settings.

Clinical adoption

Limited clinical data and lack of extensive trials hamper widespread acceptance. The competitive landscape favors well-established agents, resulting in slow growth prospects for midozalam hydrochloride.

Market Drivers and Barriers

Drivers:

  • Need for rapid-onset anesthetic agents.
  • Short procedural durations.
  • Preference for agents with quick recovery times.

Barriers:

  • Regulatory restrictions due to safety concerns.
  • Limited commercial availability.
  • Competition from entrenched drugs with established safety profiles.

Financial Trajectory

Market Size and Growth Potential

The global anesthetic agents market was valued at approximately $8.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2030[1]. However, drugs like midozalam hydrochloride represent a minimal fraction, estimated below 1%, due to limited formulation availability and market penetration.

Revenue Estimates

Given the niche position, revenue for midozalam hydrochloride likely remains under $10 million annually, primarily derived from research or specialty applications. The absence of commercialized, large-scale sales reflects regulatory limitations and competition.

Investment and R&D Outlook

Pharmaceutical companies have shown little recent R&D activity specifically targeting midozalam hydrochloride. Future financial growth depends on potential regulatory approvals, new formulation developments, or repositioning for alternative indications.

Pricing Dynamics

Limited data on pricing; off-label or research use prices tend to be higher than standard anesthetic agents. Commercialized formulations, if developed, could price in line with benzodiazepines—roughly $1-3 per dose, varying by region.

Market Entry and Exit Trends

Few recent entrants suggest low investment interest. Companies with existing benzodiazepine portfolios may consider development if regulatory pathways ease or new applications emerge.

Summary of Market and Financial Outlook

Aspect Status Key Figures
Market size (2022) Minimal, under $10 million Estimated based on niche use
Growth prospects Limited; driven by anesthesia demand Global anesthetic market CAGR 4-5%
Main barriers Regulatory restrictions, competition from established drugs
R&D activity Sparse; no significant recent developments
Price per dose Estimated $1-3; varies by region

Key Takeaways

  • Midozalam hydrochloride remains a niche anesthetic agent with limited commercial penetration due to regulatory and market barriers.
  • The global anesthetic market shows growth, but midozalam hydrochloride accounts for a fraction of this sector.
  • Financial revenues are minimal, with no significant recent investments or development activity reported.
  • Future prospects hinge on regulatory changes, new formulations, or novel indications.

FAQs

1. Why is midozalam hydrochloride not widely marketed?
It faces regulatory restrictions due to safety concerns and lacks substantial clinical data to support broad adoption.

2. How does midozalam hydrochloride compare to other benzodiazepines?
It has a rapid onset and short duration similar to midazolam, but clinical adoption is limited beyond research or specialized settings.

3. What are the primary competitors in the anesthetic market?
Midazolam, propofol, and ketamine dominate the market, offering well-established safety profiles and wider regulatory approval.

4. Is there any ongoing development for midozalam hydrochloride?
There is currently little to no public indication of active R&D programs targeting this compound.

5. Can midozalam hydrochloride find new clinical applications?
Potential exists if future research demonstrates unique benefits or addresses unmet medical needs, but current market dynamics do not support expected growth.


Sources
[1] Grand View Research, “Anesthetic Drugs Market Size, Share & Trends Analysis Report,” 2023.

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