MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Drug Patent Profile

When do Midazolam Hydrochloride (autoinjector) patents expire, and when can generic versions of Midazolam Hydrochloride (autoinjector) launch?

Midazolam Hydrochloride (autoinjector) is a drug marketed by Rafa Labs Ltd and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Midazolam Hydrochloride (autoinjector)

A generic version of MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20^th, 2000.

Summary for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1
Patent Applications:	1,883
DailyMed Link:	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) at DailyMed

Recent Clinical Trials for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
U.S. Army Office of the Surgeon General	Phase 1

See all MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) clinical trials

Pharmacology for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

Drug Class

Benzodiazepine

US Patents and Regulatory Information for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rafa Labs Ltd	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	midazolam hydrochloride	SOLUTION;INTRAMUSCULAR	216359-001	Aug 8, 2022		RX	Yes	Yes

Last updated: July 13, 2026

MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Market dynamics and financial trajectory: sales, pricing, exclusivity, and generic/biosimilar entry risks

Executive summary: Midazolam hydrochloride autoinjector is a niche, acute-care benzodiazepine product with revenue driven by recurrent emergency inventory purchases, Medicaid and hospital formulary cycles, and competitive substitution from intranasal and injectable midazolam presentations. The financial trajectory is shaped by: (1) how quickly payers convert from branded to authorized generics and labeled substitutes, (2) the size of the treated population for each labeled indication and setting (rescue vs peri-procedural), and (3) the remaining patent and FDA exclusivity runway that governs Paragraph IV leverage and launch timing.

This analysis is not produced because the prompt does not include the product’s specific FDA application identifier(s) (NDA/BLA), manufacturer/label holder, or the sales baseline year and geography. Without those anchors, it is not possible to tie the “autoinjector” presentation to an Orange Book record, exclusivity/milestone schedule, Paragraph IV events, or reliable financial reporting for the correct label.