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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 two 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

Drug Master File Entries: see list10
Suppliers / Packaging: see list1

Pharmacology for Ingredient: bupivacaine

Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: bupivacaine

2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula
Status: Recruiting Condition: Infraclavicular Brachial Plexus Block

Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Status: Completed Condition: Shoulder Pain; Rotator Cuff Tear

ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Status: Completed Condition: Spinal Anesthesia; Total Knee Replacement Arthroplasty

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION070968-001Oct 13, 1987RXNo<disabled><disabled>
Amphastar Pharms Inc
bupivacaine hydrochloride; lidocaine hydrochloride
INJECTABLE;INJECTION021496-001May 23, 2003DISCNNo<disabled><disabled>
Intl Medicated
bupivacaine hydrochloride
INJECTABLE;INJECTION076012-002Jan 9, 2002DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: bupivacaine

Country Document Number Publication Date
European Patent Office1014946Jul 05, 2000
Cyprus1110135Jan 14, 2015
Portugal1014946Jul 06, 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.

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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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