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Midazolamis 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.
Summary for midazolam
|Drug Master File Entries:||9|
|Finished Product Suppliers / Packagers:||2|
|Raw Ingredient (Bulk) Api Vendors:||42|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for midazolam|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for midazolam|
|What excipients (inactive ingredients) are in midazolam?||midazolam excipients list|
|DailyMed Link:||midazolam at DailyMed|
Recent Clinical Trials for midazolam
Identify potential brand extensions & 505(b)(2) entrants
|Wake Forest University Health Sciences||Early Phase 1|
|Ciusss de L'Est de l'Île de Montréal||N/A|
Generic filers with tentative approvals for MIDAZOLAM
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 Class||Benzodiazepine |
|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|
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
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