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NDA

CHLOROPROCAINE HYDROCHLORIDE | N208791 | B BRAUN MEDICAL INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

2029

2030

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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

29 trials from ClinicalTrials.gov — 3 recruiting, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion NCT07839039	N/A	Not Yet Recruiting	Giorgio Veneziano	10	2026-11 → 2028-12
Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy NCT07674576	Phase 3	Not Yet Recruiting	CMC Ambroise Paré	60	2026-09-01 → 2028-09-01
Targeted Nerve Injection to the Knee (Nerve to Vastus Medialis): Comparing Two Adductor Canal Block Approaches NCT07444827	Phase 4	Not Yet Recruiting	Duke University	25	2027-01-01 → 2027-12-01
Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture NCT01719237	Phase 4	Completed	University of New Mexico	60	2009-08 → 2010-11
ED90 of 3% Chloroprocaine for Cervical Cerclage NCT03805438	Phase 4	Completed	Duke University	47	2019-02-07 → 2020-10-23
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population NCT03918798	Phase 2	Completed	Sintetica SA	164	2019-02-14 → 2025-10-17
Epidural Anesthesia With Chloroprocaine Versus Lidocaine NCT02287870	Phase 4	Completed	Jinling Hospital, China	120	2008-01 → 2008-06
Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures NCT03428230	Phase 2	Completed	Sintetica SA	60	2018-08-06 → 2019-10-22
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine NCT04369950	Phase 4	Completed	The University of Texas Health Science Center, Houston	44	2020-05-11 → 2021-07-11
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour NCT01909089	Phase 4	Completed	University Hospital, Ghent	40	2013-10-17 → 2017-10-18

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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) · 1 use code

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