MIDAZOLAM IN 0.8% SODIUM CHLORIDE Drug Patent Profile
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Which patents cover Midazolam In 0.8% Sodium Chloride, and what generic alternatives are available?
Midazolam In 0.8% Sodium Chloride is a drug marketed by Exela Pharma and is included in one NDA.
The generic ingredient in MIDAZOLAM IN 0.8% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the midazolam profile page.
Summary for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1,455 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MIDAZOLAM IN 0.8% SODIUM CHLORIDE at DailyMed |
Recent Clinical Trials for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
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 |
Pharmacology for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
| Drug Class | Benzodiazepine |
Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
US Patents and Regulatory Information for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-001 | Jul 20, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-002 | Jul 20, 2022 | 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 IN 0.8% SODIUM CHLORIDE
| 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 |
