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Last Updated: November 30, 2022

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, 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-six NDAs. There are twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-one 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

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Recent Clinical Trials for bupivacaine

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SponsorPhase
University of NottinghamN/A
Wake Forest University Health SciencesPhase 1
Kansas City Heart Rhythm Research FoundationPhase 1

See all bupivacaine clinical trials

Pharmacology for bupivacaine
Drug ClassAmide Local Anesthetic
Physiological Effect Local 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eugia Pharma BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 203895-002 Nov 5, 2013 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Steriscience BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 091487-003 Oct 18, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022046-001 Jul 13, 1983 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022496-001 Oct 28, 2011 See Plans and Pricing See Plans and Pricing
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 See Plans and Pricing See Plans and Pricing
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 See Plans and Pricing See Plans and Pricing
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 See Plans and Pricing See Plans and Pricing
>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 (see section 5.1):• 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 1112625 See Plans and Pricing
Norway 20071914 See Plans and Pricing
Canada 3167217 SYSTEMES D'ADMINISTRATION DE MEDICAMENT A LIBERATION PROLONGEE AVEC IMPURETES REDUITES ET PROCEDES ASSOCIES (SUSTAINED RELEASE DRUG DELIVERY SYSTEMS WITH REDUCED IMPURITIES AND RELATED METHODS) See Plans and Pricing
Serbia 52198 RASTVOR LOKALNOG ANESTETIKA KOJI SADRŽI SAIB SA ODRŽIVIM DELOVANJEM (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING SAIB) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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