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Last Updated: March 29, 2024

Bupivacaine - Generic Drug Details


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

Bupivacaine is the generic ingredient in sixteen 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:
INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK
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
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
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Innocoll Pharms XARACOLL bupivacaine hydrochloride IMPLANT;IMPLANTATION 209511-001 Aug 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-004 May 12, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 Y ⤷  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
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 ⤷  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 022496-001 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
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
>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
Austria E537844 ⤷  Try a Trial
South Korea 20130136595 SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING PREFERABLY A SUGAR ESTER SUCH AS SAIB ⤷  Try a Trial
Eurasian Patent Organization 014852 СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ (CONTROLLED DELIVERY SYSTEM) ⤷  Try a Trial
South Korea 101351771 ⤷  Try a Trial
European Patent Office 1809329 COMPOSITION LOCALE ANESTHESIQUE A DELIVRANCE SOUTENUE CONTENANT AIBS (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING SAIB) ⤷  Try a Trial
Eurasian Patent Organization 201001885 СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ ⤷  Try a Trial
Brazil 112022013784 SISTEMAS DE DISTRIBUIÇÃO DE FÁRMACOS DE LIBERAÇÃO PROLONGADA COM IMPUREZAS REDUZIDAS E MÉTODOS RELACIONADOS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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