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

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

Anatomical Therapeutic Chemical (ATC) Classes for CHLOROPROCAINE HYDROCHLORIDE

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
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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
Fresenius Kabi Usa	NESACAINE-MPF	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
B Braun Medical Inc	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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
Hospira	CHLOROPROCAINE HYDROCHLORIDE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	087446-001	Apr 16, 1982		DISCN	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 CHLOROPROCAINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3681473	FORMULATIONS TOPIQUES DE CHLOROPROCAÏNE (TOPICAL FORMULATIONS OF CHLOROPROCAINE)	⤷ Sign Up
Jordan	P20200010	صيغ موضعية من كلوروبروكائين وطرق استخدامها (TOPICAL FORMULATIONS OF CHLOROPROCAINE AND METHODS OF USING SAME)	⤷ Sign Up
Spain	2441790		⤷ Sign Up
Poland	1931304		⤷ Sign Up
Singapore	11202000992R	TOPICAL FORMULATIONS OF CHLOROPROCAINE	⤷ Sign Up
Slovenia	1931304		⤷ Sign Up
South Korea	20150085131	경막 내 반복 투여를 위한 클로로프로카인계 제약 조성물 (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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