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Last Updated: July 3, 2020

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Bupivacaine hydrochloride - Generic Drug Details

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

Bupivacaine hydrochloride is the generic ingredient in eleven branded drugs marketed by 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 NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for bupivacaine hydrochloride. Fourteen suppliers are listed for this compound.

Recent Clinical Trials for bupivacaine hydrochloride

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SponsorPhase
University of PennsylvaniaPhase 4
University of Missouri-ColumbiaPhase 4
Our Lady of the Lake HospitalN/A

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US Patents and Regulatory Information for bupivacaine hydrochloride

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 AND EPINEPHRINE bupivacaine hydrochloride; epinephrine INJECTABLE;INJECTION 071171-001 Jun 16, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Huons BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;SPINAL 212822-001 Dec 30, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 018304-002 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 071202-001 Apr 15, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070597-001 Mar 3, 1987 AP RX No No   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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Baxter
Mallinckrodt
AstraZeneca
McKinsey

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