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Last Updated: March 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 patent protection?

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. Twenty 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: 20
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
Anatomical Therapeutic Chemical (ATC) Classes 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 AND EPINEPHRINE bupivacaine hydrochloride; epinephrine INJECTABLE;INJECTION 071167-001 Jun 16, 1988 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Steriscience BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 091487-002 Oct 18, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUPIVACAINE HYDROCHLORIDE KIT bupivacaine hydrochloride INJECTABLE;INJECTION 019978-001 Sep 3, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070552-001 May 21, 1986 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070590-001 Feb 17, 1987 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070586-001 Mar 3, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kindos BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 216039-002 Jun 23, 2023 AP RX 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

International Patents for bupivacaine hydrochloride

Country Patent Number Title Estimated Expiration
Cyprus 1121568 ⤷  Try a Trial
Lithuania 2802624 ⤷  Try a Trial
Slovenia 3085363 ⤷  Try a Trial
Croatia P20171635 ⤷  Try a Trial
Turkey 201905174 ⤷  Try a Trial
Poland 3536748 ⤷  Try a Trial
Eurasian Patent Organization 027745 МОДИФИЦИРОВАННЫЙ КОЛЛАГЕН (MODIFIED COLLAGEN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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