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Last Updated: August 4, 2020

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BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE - Generic Drug Details

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What are the generic drug sources for bupivacaine hydrochloride; epinephrine bitartrate and what is the scope of freedom to operate?

Bupivacaine hydrochloride; epinephrine bitartrate is the generic ingredient in four branded drugs marketed by Hospira, Septodont, and Fresenius Kabi Usa, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for bupivacaine hydrochloride; epinephrine bitartrate. Eight suppliers are listed for this compound.

Summary for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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

SponsorPhase
Sunnybrook Health Sciences CentreN/A
Cosmozone Dental ClinicN/A

See all BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE clinical trials

Pharmacology for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

US Patents and Regulatory Information for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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 016964-007 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
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
Hospira BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022046-001 Jul 13, 1983 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-010 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-008 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-004 Approved Prior to Jan 1, 1982 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
>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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