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Last Updated: April 19, 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

Sponsor	Phase
Johns Hopkins University	Phase 3
Sintetica SA	Phase 2/Phase 3
Sintetica SA	Phase 1/Phase 2

See all chloroprocaine hydrochloride clinical trials

Pharmacology for chloroprocaine hydrochloride

Drug Class	Ester Local Anesthetic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for chloroprocaine hydrochloride

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Glossary

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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
Hospira	CHLOROPROCAINE HYDROCHLORIDE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	087447-001	Apr 16, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	NESACAINE-MPF	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435-007	May 2, 1996	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Harrow Eye	IHEEZO	chloroprocaine hydrochloride	GEL;OPHTHALMIC	216227-001	Sep 27, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hikma	CHLOROPROCAINE HYDROCHLORIDE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	040273-001	Sep 9, 1998	AP	RX	No	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

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Country	Patent Number	Title	Estimated Expiration
Cuba	20200019	FORMULACIONES TÓPICAS DE CLOROPROCAÍNA Y MÉTODOS PARA PREPARAR LAS MISMAS	⤷ Try a Trial
Ukraine	115078	СПОСІБ ЦЕНТРАЛЬНОЇ ЛОКОРЕГІОНАРНОЇ АНЕСТЕЗІЇ ФАРМАЦЕВТИЧНИМ ВОДНИМ РОЗЧИНОМ ХЛОРОПРОКАЇНУ (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION)	⤷ Try a Trial
Portugal	1931304		⤷ Try a Trial
Denmark	1931304		⤷ Try a Trial
Singapore	11202000992R	TOPICAL FORMULATIONS OF CHLOROPROCAINE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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