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Last Updated: January 17, 2021

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Bupivacaine - Generic Drug Details

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What are the generic sources for bupivacaine and what is the scope of patent protection?

Bupivacaine is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Innocoll Pharms, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has nineteen patent family members in nine countries.

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

Drug Prices for bupivacaine

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Recent Clinical Trials for bupivacaine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of CalgaryPhase 4
Alberta Health ServicesPhase 4
Alberta Hip and Knee ClinicPhase 4

See all bupivacaine clinical trials

Pharmacology for bupivacaine
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for bupivacaine

US Patents and Regulatory Information for bupivacaine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;SPINAL 071810-001 Dec 11, 1987 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine INJECTABLE;INJECTION 071165-001 Jun 16, 1988 RX No Yes   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070609-001 Mar 3, 1987 AP RX No No   Start Trial   Start Trial   Start Trial
Septodont BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 077250-001 Sep 27, 2006 RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bupivacaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011   Start Trial   Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011   Start Trial   Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011   Start Trial   Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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