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Details for Generic Name: bupivacaine

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Bupivacaine is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Hospira, Sagent Agila, Aurobindo Pharma Ltd, Intl Medicated, Fresenius Kabi Usa, Septodont, and Amphastar Pharms Inc, and is included in thirty-six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty patent family members in fifteen countries.

There are ten drug master file entries for bupivacaine. One supplier is listed for this compound.

Summary for Generic Name: bupivacaine

Tradenames:13
Patents:3
Applicants:8
NDAs:36
Drug Master File Entries: see list10
Suppliers / Packaging: see list1

Pharmacology for Ingredient: bupivacaine

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: bupivacaine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
BUPIVACAINE HYDROCHLORIDE KIT
bupivacaine hydrochloride
INJECTABLE;INJECTION019978-003Sep 3, 1992DISCNNo<disabled><disabled>
Hospira
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION070609-001Mar 3, 1987RXNo<disabled><disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 2011RXYes8,834,921<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: bupivacaine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-001Oct 28, 20116,132,766<disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 20116,132,766<disabled>
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International Patent Family for Ingredient: bupivacaine

Country Document Number Publication Date
Portugal1014946Jul 06, 2010
Spain2343767Aug 09, 2010
Japan4467789May 26, 2010
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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