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Last Updated: November 21, 2024

CHLOROPROCAINE HYDROCHLORIDE - Generic Drug Details


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

Chloroprocaine hydrochloride is the generic ingredient in five branded drugs marketed by Harrow Eye, Hikma, Hospira, Fresenius Kabi Usa, and B Braun Medical Inc, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chloroprocaine hydrochloride has fifty-three patent family members in thirty-six countries.

There are two drug master file entries for chloroprocaine hydrochloride. Six suppliers are listed for this compound.

Summary for CHLOROPROCAINE HYDROCHLORIDE
International Patents:53
US Patents:3
Tradenames:5
Applicants:5
NDAs:6
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 58
Clinical Trials: 35
Patent Applications: 1,180
What excipients (inactive ingredients) are in CHLOROPROCAINE HYDROCHLORIDE?CHLOROPROCAINE HYDROCHLORIDE excipients list
DailyMed Link:CHLOROPROCAINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CHLOROPROCAINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johns Hopkins UniversityPhase 3
Sintetica SAPhase 2/Phase 3
Sintetica SAPhase 1/Phase 2

See all CHLOROPROCAINE HYDROCHLORIDE clinical trials

Pharmacology for CHLOROPROCAINE HYDROCHLORIDE
Drug ClassEster Local Anesthetic
Physiological EffectLocal Anesthesia

US Patents and Regulatory Information for CHLOROPROCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa NESACAINE-MPF chloroprocaine hydrochloride INJECTABLE;INJECTION 009435-006 May 2, 1996 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NESACAINE-MPF chloroprocaine hydrochloride INJECTABLE;INJECTION 009435-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira CHLOROPROCAINE HYDROCHLORIDE chloroprocaine hydrochloride INJECTABLE;INJECTION 087446-001 Apr 16, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa NESACAINE chloroprocaine hydrochloride INJECTABLE;INJECTION 009435-002 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Harrow Eye IHEEZO chloroprocaine hydrochloride GEL;OPHTHALMIC 216227-001 Sep 27, 2022 RX Yes Yes ⤷  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 CHLOROPROCAINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Costa Rica 20200133 FORMULACIONES TÓPICAS DE CLOROPROCAÍNA Y MÉTODOS PARA UTILIZAR LAS MSIMAS (TOPICAL FORMULATIONS OF CHLOROPROCAINE) ⤷  Sign Up
Australia 2013356855 Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration ⤷  Sign Up
Argentina 099443 COMPOSICIÓN FARMACÉUTICA A BASE DE CLOROPROCAÍNA PARA LA ADMINISTRACIÓN INTRATECAL REPETIDA ⤷  Sign Up
Colombia 2020002985 Formulaciones tópicas de cloroprocaína ⤷  Sign Up
South Korea 102162587 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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