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Last Updated: July 19, 2024


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

Midazolam Hydrochloride is a drug marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Pai Holdings, Rising, Akorn, Padagis Us, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Steriscience. and is included in thirty-six NDAs.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-six 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

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

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Drug patent expirations by year for MIDAZOLAM HYDROCHLORIDE
Recent Clinical Trials for MIDAZOLAM HYDROCHLORIDE

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

University Hospital of North NorwayPhase 1/Phase 2
University of ExeterPhase 1/Phase 2
Kancera ABPhase 1

See all MIDAZOLAM HYDROCHLORIDE clinical trials

Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for MIDAZOLAM HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM HYDROCHLORIDE

US Patents and Regulatory Information for MIDAZOLAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pai Holdings MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 078141-001 May 30, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira Inc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075409-002 Jun 20, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharm Assoc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 077115-001 Sep 9, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075481-001 Jun 30, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 076058-001 Mar 15, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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