MIDOZALAM HYDROCHLORIDE Drug Patent Profile

When do Midozalam Hydrochloride patents expire, and when can generic versions of Midozalam Hydrochloride launch?

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 20^th, 2000.

Summary for MIDOZALAM HYDROCHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1

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
Onesource Specialty	MIDOZALAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	090316-002	May 4, 2011	AP	RX	No	No

MIDOZALAM HYDROCHLORIDE: Investment Scenario and Fundamentals Analysis

Last updated: May 1, 2026

No complete, verifiable patent, regulatory, or commercial dataset is available for “MIDOZALAM HYDROCHLORIDE” under that exact trade/generic string. Without a name-resolving identifier (INN/USAN/brand, applicant/assignee, NDC, EMA product code, or a confirmed salt-form listing), an investment and fundamentals assessment would require assumptions that cannot be supported by hard sources.

What is MIDOZALAM hydrochloride in the regulatory record?

None.

A dataset-level check cannot be completed from the provided drug name alone because “MIDOZALAM HYDROCHLORIDE” does not resolve to a single, citable regulatory or patent entity in the available citation framework.

What is the patent position (composition, salts, polymorphs, use)

None.

A patent-position analysis needs at least one of the following to anchor claim charts and status timelines: patent family numbers, assignee/application identifiers, or a regulatory reference mapping to a filing dossier. No such anchor can be established from the provided string.

What is the market and competitive intensity

None.

Market fundamentals require confirmed product identity and market authorization scope (indication, geography, dosage forms, label restrictions), none of which can be verified for the provided name.

What is the investment scenario (risk, catalysts, downside)

None.

A scenario build depends on confirmed:

• regulatory status and launch dates,
• patent expiry and blocking positions,
• competitor pipelines and label-forcing entry timing,
• payer positioning and therapeutic class demand drivers,
• manufacturing constraints and regulatory exclusivities.

Those inputs cannot be validated for this specific drug string.

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Key Takeaways

• No investable fundamentals can be produced for “MIDOZALAM HYDROCHLORIDE” from verifiable sources using only the provided name.
• A correct analysis requires a resolvable regulatory/patent identity; without that, any investment scenario would be non-data-driven.

FAQs

1. Can you analyze patents for MIDOZALAM hydrochloride by name only?
   Not without a resolvable patent family or regulatory mapping.

2. Can you determine market size or launch trajectory from the name alone?
   No, because authorization status and indications cannot be verified.

3. What would typically anchor a patent and investment analysis for a salt-form drug?
   Identifiers like INN/USAN confirmation, NDC/EMA codes, applicant/assignee, and patent family numbers.

4. How do you validate whether a salt name corresponds to a distinct patent asset?
   By matching the salt-form to composition-of-matter, salt-specific claims, and regulatory filings.

5. What are the minimum hard-data elements needed for a credible investment scenario?
   Confirmed regulatory identity, geography/indication, patent family mapping, expiry timelines, and competitive pipeline entries.

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References

[1] No citable sources were provided or resolvable from the given drug string.