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Bupivacaine - Generic Drug Details

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Bupivacaine is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Fresenius Kabi Usa, Sagent Agila, Hospira, Intl Medicated, Aurobindo Pharma Ltd, Septodont, and Amphastar Pharms Inc, and is included in thirty-seven 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:37
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION016964-010Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Fresenius Kabi Usa
SENSORCAINE
bupivacaine hydrochloride
INJECTABLE;INJECTION070553-001May 21, 1986RXNo<disabled><disabled>
Hospira
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION016964-008Approved Prior to Jan 1, 1982RXYes<disabled><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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Non-Orange Book Patents for Generic Ingredient: bupivacaine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,045,824 Sustained-release liposomal anesthetic compositions<disabled in preview>
9,192,575Sustained-release liposomal anesthetic compositions<disabled in preview>
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International Patent Family for Ingredient: bupivacaine

Country Document Number Estimated Expiration
Australia9494298<disabled in preview>
Denmark1014946<disabled in preview>
Japan2001516714<disabled in preview>
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