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.
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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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-002 | Jul 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
