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Last Updated: March 1, 2021

DrugPatentWatch Database Preview

Bupivacaine hydrochloride - Generic Drug Details

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

Bupivacaine hydrochloride is the generic ingredient in twelve branded drugs marketed by 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-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has twenty-six patent family members in fifteen countries.

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

Summary for bupivacaine hydrochloride
International Patents:26
US Patents:1
Tradenames:12
Applicants:12
NDAs:41
Drug Master File Entries: 12
Suppliers / Packagers: 13
Bulk Api Vendors: 94
Clinical Trials: 1,280
Patent Applications: 910
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in bupivacaine hydrochloride?bupivacaine hydrochloride excipients list
DailyMed Link:bupivacaine hydrochloride at DailyMed
Recent Clinical Trials for bupivacaine hydrochloride

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

SponsorPhase
Laval UniversityPhase 3
CHU de Quebec-Universite LavalPhase 3
The Geneva FoundationN/A

See all bupivacaine hydrochloride clinical trials

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
Novocol Healthcare BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 211096-001 Feb 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Asi BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 091487-002 Oct 18, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira MARCAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-006 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Asi BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 091503-002 Oct 18, 2011 DISCN No No   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 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
>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:

Baxter
McKesson
Express Scripts
Colorcon
Johnson and Johnson
Dow

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