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Last Updated: March 18, 2024

Chloroprocaine hydrochloride - Generic Drug Details


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

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: 34
Patent Applications: 1,180
Formulation / Manufacturing:see details
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 009435-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun Medical Inc CLOROTEKAL chloroprocaine hydrochloride SOLUTION;INTRATHECAL 208791-001 Sep 26, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma CHLOROPROCAINE HYDROCHLORIDE chloroprocaine hydrochloride INJECTABLE;INJECTION 040273-002 Sep 9, 1998 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa NESACAINE chloroprocaine hydrochloride INJECTABLE;INJECTION 009435-002 Approved Prior to Jan 1, 1982 AP RX 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

International Patents for chloroprocaine hydrochloride

Country Patent Number Title Estimated Expiration
Russian Federation 2648823 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ОСНОВЕ ХЛОРПРОКАИНА ДЛЯ ПОВТОРНОГО ИНТРАТЕКАЛЬНОГО ВВЕДЕНИЯ (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION) ⤷  Try a Trial
Japan 2020533321 クロロプロカインの表面麻酔製剤 ⤷  Try a Trial
Philippines 12020550029 TOPICAL FORMULATIONS OF CHLOROPROCAINE ⤷  Try a Trial
Cuba 20200019 FORMULACIONES TÓPICAS DE CLOROPROCAÍNA Y MÉTODOS PARA PREPARAR LAS MISMAS ⤷  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.