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Last Updated: July 2, 2020

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BUPIVACAINE - Generic Drug Details

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

Bupivacaine is the generic ingredient in twelve branded drugs marketed by Pacira Pharms Inc, 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-one NDAs. There is one patent 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

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SponsorPhase
Turku University HospitalPhase 4
Obstetric Anaesthetists' AssociationPhase 4
University of PennsylvaniaPhase 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 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-013 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183-001 May 13, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692-001 May 4, 1984 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 070967-001 Oct 13, 1987 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 018053-002 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start Trial   Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes 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 022496-001 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 022496-001 Oct 28, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
AstraZeneca
Dow
Moodys
Johnson and Johnson

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