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CLOROTEKAL

NDA

CHLOROPROCAINE HYDROCHLORIDE | N208791 | B BRAUN MEDICAL INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

8969412

Sep. 5, 2026

9504666

Dec. 11, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SACHLOROPROCAINE HYDROCHLORIDE

DMF 80021989

EDMOND PHARMA SRLCHLOROPROCAINE HYDROCHLORIDE

DMF 356982021

SHANGHAI WONDER PHARMACEUTICAL CO LTDCHLOROPROCAINE HYDROCHLORIDE

DMF 392682023

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveCHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 231472009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML (10MG/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INTRATHECAL | Approved: Sep 26, 2017

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8969412	Sep 5, 2026	—	—	Yes		—
9504666	Dec 11, 2033	—	—	Yes	—	—