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Last Updated: April 19, 2024

Bupivacaine hydrochloride - Generic Drug Details


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

Bupivacaine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Innocoll Pharms, Civica, Eugia Pharma, Hikma Pharms, Hospira, Kindos, Somerset, Steriscience, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has seventy-nine patent family members in twenty-three countries.

There are six drug master file entries for bupivacaine hydrochloride. Nineteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride
International Patents:79
US Patents:2
Tradenames:13
Applicants:15
NDAs:46
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 19
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 1,623
Patent Applications: 1,076
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
University Hospital "Sestre Milosrdnice"N/A
National Trauma CenterN/A
Johnny K. LeePhase 4

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

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 bupivacaine hydrochloride INJECTABLE;INJECTION 018053-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MARCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 018692-001 May 4, 1984 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intl Medicated BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 076012-002 Jan 9, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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