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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019386

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NDA 019386 describes BREVIBLOC IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the BREVIBLOC IN PLASTIC CONTAINER profile page.

The generic ingredient in BREVIBLOC IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
Summary for 019386
Tradename:BREVIBLOC IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:esmolol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 019386
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 019386
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386 NDA Baxter Healthcare Corporation 10019-055 10019-055-61 10 BAG in 1 CARTON (10019-055-61) > 250 mL in 1 BAG
BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386 NDA Baxter Healthcare Corporation 10019-075 10019-075-87 10 BAG in 1 CARTON (10019-075-87) > 100 mL in 1 BAG
Paragraph IV (Patent) Challenges for 019386
Tradename Dosage Ingredient NDA Submissiondate
BREVIBLOC IN PLASTIC CONTAINER INJECTABLE;INJECTION esmolol hydrochloride 019386 2014-01-31
BREVIBLOC INJECTABLE;INJECTION esmolol hydrochloride 019386 2014-01-31
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER INJECTABLE;INJECTION esmolol hydrochloride 019386 2014-01-31

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Aug 15, 1988TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Feb 16, 2001TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 12, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jul 12, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 019386

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-003 Aug 15, 1988   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER esmolol hydrochloride INJECTABLE;INJECTION 019386-005 Jan 27, 2003   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-007 May 28, 2003   Start Trial   Start Trial
Baxter Hlthcare BREVIBLOC esmolol hydrochloride INJECTABLE;INJECTION 019386-006 Feb 25, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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