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Last Updated: February 9, 2023

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

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

SponsorPhase
Abraham NunesPhase 3
Nova Scotia Health AuthorityPhase 3
GCS Ramsay Santé pour l'Enseignement et la RechercheN/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.

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

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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.