MIDAZOLAM IN 0.8% SODIUM CHLORIDE Drug Patent Profile
✉ Email this page to a colleague
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 B Braun Medical and Exela Pharma and is included in two NDAs.
The generic ingredient in MIDAZOLAM IN 0.8% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for MIDAZOLAM IN 0.8% SODIUM CHLORIDE?
- What are the global sales for MIDAZOLAM IN 0.8% SODIUM CHLORIDE?
- What is Average Wholesale Price for MIDAZOLAM IN 0.8% SODIUM CHLORIDE?
Summary for MIDAZOLAM IN 0.8% SODIUM CHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1,722 |
| 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 |
|---|---|
| Novartis Pharmaceuticals | PHASE1 |
| Sunnybrook Health Sciences Centre | PHASE3 |
| University Health Network, Toronto | PHASE3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun Medical | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 218454-001 | May 1, 2025 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-002 | Jul 20, 2022 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| B Braun Medical | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 218454-002 | May 1, 2025 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Pharma | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 215868-001 | Jul 20, 2022 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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/002267Treatment 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 |
