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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.

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: 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

Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain
Status: Not yet recruiting Condition: Pain

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
bupivacaine hydrochloride; epinephrine
INJECTABLE;INJECTION071165Jun 16, 1988RXYes<disabled><disabled>
Amphastar Pharms Inc
bupivacaine hydrochloride; lidocaine hydrochloride
INJECTABLE;INJECTION021496May 23, 2003DISCNNo<disabled><disabled>
Intl Medicated
bupivacaine hydrochloride
INJECTABLE;INJECTION076012Jan 9, 2002DISCNNo<disabled><disabled>
Pacira Pharms Inc
INJECTABLE, LIPOSOMAL;INJECTION022496Oct 28, 2011RXYes8,834,921<disabled>Y<disabled>
bupivacaine hydrochloride
INJECTABLE;INJECTION070584Feb 17, 1986RXNo<disabled><disabled>
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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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