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Last Updated: March 4, 2021

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Midazolam - Generic Drug Details

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What are the generic drug sources for midazolam and what is the scope of freedom to operate?

Midazolam is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn Inc, Apothecon, Atlantide, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Mylan Asi, HLR, Meridian Medcl Techn, Akorn, Paddock Llc, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in thirty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for midazolam
Drug Prices for midazolam

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Recent Clinical Trials for midazolam

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

Rafa LaboratoriesPhase 1
Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear MedicalPhase 1
Ology BioservicesPhase 1

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Generic filers with tentative approvals for MIDAZOLAM
Applicant Application No. Strength Dosage Form

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for midazolam
Drug ClassBenzodiazepine

US Patents and Regulatory Information for midazolam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Asi MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 090315-001 Nov 29, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Igi Labs Inc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075263-001 Jun 26, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 208878-001 Mar 28, 2017 RX No No   Start Trial   Start Trial   Start Trial
Apothecon MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075641-001 Oct 19, 2000 DISCN 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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