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Last Updated: March 5, 2024

Bupivacaine - Generic Drug Details


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

Bupivacaine is the generic ingredient in fifteen branded drugs marketed by Pacira Pharms Inc, Innocoll, 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, Amphastar Pharms Inc, and Heron Theraps Inc, and is included in forty-nine NDAs. There are thirty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-eight patent family members in thirty countries.

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

Drug Prices for bupivacaine

See drug prices for bupivacaine

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bupivacaine
Generic Entry Dates for bupivacaine*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
Dosage:
INJECTABLE, LIPOSOMAL;INJECTION
Generic Entry Dates for bupivacaine*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, EXTENDED RELEASE;INFILTRATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bupivacaine

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 clinical trials

Pharmacology for bupivacaine
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for bupivacaine
Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine
Paragraph IV (Patent) Challenges for BUPIVACAINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXPAREL Injectable Suspension bupivacaine 133 mg/10 mL 022496 1 2021-12-28
EXPAREL Injectable Suspension bupivacaine 266 mg/20 mL 022496 1 2021-08-20

US Patents and Regulatory Information for bupivacaine

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 071171-001 Jun 16, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-003 May 12, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-001 May 12, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-002 May 12, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 018304-005 Sep 2, 1983 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-003 May 12, 2021 DISCN Yes 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

Expired US Patents for bupivacaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for bupivacaine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pacira Ireland Limited Exparel liposomal bupivacaine EMEA/H/C/004586
Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
Authorised no no no 2020-11-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for bupivacaine

Country Patent Number Title Estimated Expiration
Cyprus 1118360 ⤷  Try a Trial
Japan 2009073839 CONTROLLED DELIVERY SYSTEM ⤷  Try a Trial
Poland 1809329 ⤷  Try a Trial
Norway 342596 ⤷  Try a Trial
Ukraine 89505 МЕСТНАЯ АНЕСТЕТИЧЕСКАЯ КОМПОЗИЦИЯ ПРОДОЛЖИТЕЛЬНОГО ДЕЙСТВИЯ;МІСЦЕВА АНЕСТЕТИЧНА КОМПОЗИЦІЯ ТРИВАЛОЇ ДІЇ (SUSTAINED LOCAL ANESTHETIC COMPOSITION) ⤷  Try a Trial
Japan 5285374 ⤷  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.