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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

Tradenames:13
Patents:2
Applicants:8
NDAs:36
Drug Master File Entries: see list10
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: bupivacaine

Ingredient-typeAmides
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 ClinicalTrials.org
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
Hospira
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION018053-002Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
Hospira
MARCAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION016964-001Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Hospira
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION018053-003Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
Aurobindo Pharma Ltd
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION203895-001Nov 5, 2013RXNo<disabled><disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 2011RXYes8,182,835<disabled>Y<disabled>
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International Patent Family for Ingredient: bupivacaine

Country Document Number Publication Date
Portugal1014946Jul 06, 2010
European Patent Office2198854Jun 23, 2010
New Zealand503513Dec 24, 2004
Australia9494298Apr 05, 1999
Austria463238Apr 15, 2010
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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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