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Last Updated: November 29, 2022

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, Inforlife, Ucb Inc, Akorn, 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, Steriscience, HLR, Rafa Labs Ltd, MMT, Padagis Us, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in forty-two 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. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for midazolam

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Recent Clinical Trials for midazolam

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SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Ciusss de L'Est de l'Île de MontréalN/A
Jiangang SongN/A

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Generic filers with tentative approvals for MIDAZOLAM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 5MG BASE/MLINJECTABLE;INJECTION

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
Hospira MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 075856-002 Jun 13, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride SYRUP;ORAL 075873-001 Apr 30, 2002 AA RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hlr VERSED midazolam hydrochloride INJECTABLE;INJECTION 018654-001 Dec 20, 1985 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Laboratorios Lesvi 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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