MIDAZOLAM IN 0.9% SODIUM CHLORIDE Drug Patent Profile
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Which patents cover Midazolam In 0.9% Sodium Chloride, and what generic alternatives are available?
Midazolam In 0.9% Sodium Chloride is a drug marketed by Gland Pharma Ltd, Hikma, and Inforlife. and is included in three NDAs. There is one patent protecting this drug.
The generic ingredient in MIDAZOLAM IN 0.9% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the midazolam profile page.
DrugPatentWatch® Generic Entry Outlook for Midazolam In 0.9% Sodium Chloride
There are two tentative approvals for the generic drug (midazolam), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| US Patents: | 1 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 1,499 |
| DailyMed Link: | MIDAZOLAM IN 0.9% SODIUM CHLORIDE at DailyMed |
Recent Clinical Trials for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 1 |
| Medical University of South Carolina | Phase 4 |
| Ruijin Hospital | Phase 1/Phase 2 |
Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| Drug Class | Benzodiazepine |
US Patents and Regulatory Information for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
MIDAZOLAM IN 0.9% SODIUM CHLORIDE is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Midazolam in flexible bags
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting MIDAZOLAM IN 0.9% SODIUM CHLORIDE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 218993-001 | Aug 12, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159-002 | Apr 17, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 218993-002 | Aug 12, 2024 | AP | RX | No | No | ⤷ 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 0.9% 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 |
