Last Updated: August 2, 2026

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE Drug Patent Profile

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When do Midazolam Hydrochloride Preservative Free patents expire, and what generic alternatives are available?

Midazolam Hydrochloride Preservative Free is a drug marketed by Fresenius Kabi Usa, Hospira, and Onesource Specialty. and is included in three NDAs.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE 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 Preservative Free

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

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Summary for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

US Patents:	0
Applicants:	3
NDAs:	3

US Patents and Regulatory Information for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	203460-001	Aug 22, 2014	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hospira	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	075857-002	Jul 22, 2002	AP	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	203460-002	Aug 22, 2014	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hospira	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	075857-001	Jul 22, 2002	AP	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Onesource Specialty	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	090315-002	Nov 29, 2010	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

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