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Last Updated: April 25, 2024

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 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 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-012 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kindos BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 216040-002 Dec 27, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 018053-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070597-001 Mar 3, 1987 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;SPINAL 207266-001 Jul 25, 2016 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

International Patents for bupivacaine hydrochloride

Country Patent Number Title Estimated Expiration
Norway 2802624 ⤷  Try a Trial
European Patent Office 3901218 COLLAGÈNE MODIFIÉ (A MODIFIED COLLAGEN) ⤷  Try a Trial
European Patent Office 3255106 COLLAGÈNE MODIFIÉ (A MODIFIED COLLAGEN) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008117268 ⤷  Try a Trial
Eurasian Patent Organization 201790763 МОДИФИЦИРОВАННЫЙ КОЛЛАГЕН ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.