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 Inforlife and is included in one NDA. 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. Three 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 20, 2038. This may change due to patent challenges or generic licensing.
There are two tentative approvals for the generic drug (midazolam), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1,416 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MIDAZOLAM IN 0.9% SODIUM CHLORIDE at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Generic Entry Date for MIDAZOLAM IN 0.9% SODIUM CHLORIDE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Abraham Nunes | Phase 3 |
| Nova Scotia Health Authority | Phase 3 |
| GCS Ramsay Santé pour l'Enseignement et la Recherche | N/A |
Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| Drug Class | Benzodiazepine |
Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
US Patents and Regulatory Information for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
MIDAZOLAM IN 0.9% SODIUM CHLORIDE is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIDAZOLAM IN 0.9% SODIUM CHLORIDE is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Midazolam in flexible bags
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inforlife | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 211844-001 | Mar 22, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Inforlife | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 211844-002 | Mar 22, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 |
|---|---|---|---|---|---|---|---|---|---|
| Laboratorios Lesvi 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 |
