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Last Updated: May 23, 2024

BUPIVACAINE HYDROCHLORIDE - Generic Drug Details


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

Bupivacaine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Innocoll Pharms, Aspiro, 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-seven 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:16
NDAs:47
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 018053-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kindos BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 216040-001 Dec 27, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070553-001 May 21, 1986 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183-002 May 13, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Poland 3536748 ⤷  Sign Up
Spain 2645445 ⤷  Sign Up
Serbia 58935 MODIFIKOVANI KOLAGEN (A MODIFIED COLLAGEN) ⤷  Sign Up
Denmark 3255106 ⤷  Sign Up
European Patent Office 2139457 DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT POUR ASSURER UNE ANALGÉSIE LOCALE, UNE ANESTHÉSIE LOCALE OU UN BLOCAGE NERVEUX (A DRUG DELIVERY DEVICE FOR PROVIDING LOCAL ANALGESIA, LOCAL ANESTHESIA OR NERVE BLOCKADE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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