You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

MIDAZOLAM IN 0.9% SODIUM CHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 Hikma and Inforlife and is included in two 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. Four 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

< Available with Subscription >

  Try a Trial

Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Drug patent expirations by year for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Recent Clinical Trials for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Abraham NunesPhase 3
Nova Scotia Health AuthorityPhase 3
National Trauma CenterN/A

See all MIDAZOLAM IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Drug ClassBenzodiazepine
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 and one FDA Regulatory Exclusivity.

Patents protecting MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Midazolam in flexible bags
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting MIDAZOLAM IN 0.9% SODIUM CHLORIDE

PATENT CHALLENGE
Exclusivity Expiration: ⤷  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
Hikma MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 216159-001 Apr 17, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Inforlife MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 211844-002 Mar 22, 2021 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 216159-002 Apr 17, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Inforlife MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 211844-001 Mar 22, 2021 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 0.9% 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.