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Last Updated: March 29, 2024

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 nine branded drugs marketed by Exela Pharma, Hikma, Inforlife, Ucb Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Pai Holdings, Rising, Steriscience, HLR, Rafa Labs Ltd, MMT, Akorn, Padagis Us, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in forty-four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for midazolam

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Recent Clinical Trials for midazolam

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

SponsorPhase
Nova Scotia Health AuthorityPhase 3
Abraham NunesPhase 3
National Trauma CenterN/A

See all midazolam clinical trials

Generic filers with tentative approvals for MIDAZOLAM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 5MG BASE/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial5MGSPRAY;NASAL

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
Paragraph IV (Patent) Challenges for MIDAZOLAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAYZILAM Nasal Spray midazolam 5 mg/spray 211321 1 2021-06-01

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
Apothecon MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075641-001 Oct 19, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075324-002 Jun 20, 2000 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075494-001 Jun 30, 2000 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075247-002 Jun 23, 2000 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for midazolam

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Neuraxpharm Pharmaceuticals S.L. Buccolam midazolam EMEA/H/C/002267
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Authorised no no no 2011-09-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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