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.
Summary for midazolam
US Patents: | 5 |
Tradenames: | 9 |
Applicants: | 28 |
NDAs: | 44 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 1,455 |
Patent Applications: | 7,028 |
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
Sponsor | Phase |
---|---|
Nova Scotia Health Authority | Phase 3 |
Abraham Nunes | Phase 3 |
National Trauma Center | N/A |
Generic filers with tentative approvals for MIDAZOLAM
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 5MG BASE/ML | INJECTABLE;INJECTION |
⤷ Try a Trial | ⤷ Try a Trial | 5MG | SPRAY;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 Class | Benzodiazepine |
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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