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CARDENE SR

NDA

NICARDIPINE HYDROCHLORIDE | N020005 | CHIESI USA INC

3 strengths0 unique patents0 unique exclusivities

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Jubilant Generics FDA-2017-P-2660 · 6 docket documents Jubilant Generics Ltd. filed this citizen petition on April 27, 2017 pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that the discontinuation of CARDENE SR (Nicardipine Hydrochloride Extended Release Capsules, NDA 020005) was not for safety	505(q)	2017-04-28	Granted	Jubilant Generics
EKR Therapeutics, Inc. - Citizen Petition FDA-2008-P-0621 · 6 docket documents EKR Therapeutics, Inc. filed this citizen petition under 21 U.S.C. §§ 351(a), 355(b), 355(j), and 355(q) requesting that FDA refuse to allow Teva Parenteral Medicines, Inc. to relaunch its nicardipine hydrochloride injectable product (NDA 22-276, approved July 24, 2008) until Teva submits intermedia	505(q)	2008-12-03	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

29 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia NCT01175746	N/A	Completed	Yonsei University	46	2010-08 → 2011-12
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)NCT00803634	Phase 3	Completed	The Medicines Company	117	2008-12 → 2012-03
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion NCT03622060	Phase 3	Completed	Hermina Heart Center Kemayoran	600	2018-06-04 → 2019-05-22
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage NCT00226096	N/A	Completed	The George Institute	404	2005-11 → 2007-09
Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery NCT02116868	N/A	Completed	Central Hospital, Nancy, France	100	2014-03 → 2018-04
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)NCT01422616	Phase 3	Completed	The George Institute	4,587	2012-03 → 2018-08
Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries NCT03497351	N/A	Completed	Chinese PLA General Hospital	59	2018-04-15 → 2019-02-15
Blood Pressure After Endovascular Stroke Therapy-II NCT04116112	Phase 2	Completed	University of Cincinnati	120	2020-01-17 → 2022-12-15
The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability NCT01634594	Phase 4	Completed	Yonsei University	66	2012-06 → 2013-02
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department NCT00765648	Phase 4	Completed	The Cleveland Clinic	226	2008-10 → 2010-01

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

API Supply Chain14 active DMFs3 inactive

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

LUSOCHIMICA SPANICARDIPINE HYDROCHLORIDE

DMF 94931992

OLON SPANICARDIPINE HYDROCHLORIDE

DMF 101041993

CHEMWERTH INCNICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 195522006

NAVINTA LLCNICARDIPINE HYDROCHLORIDE USP

DMF 197732006

WOCKHARDT LTDNICARDIPINE HYDROCHLORIDE

DMF 212112007

LUSOCHIMICA SPANICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE)

DMF 216252008

HIKMA PHARMACEUTICALSNICARDIPINE HYDROCHLORIDE

DMF 232802009

GLAND PHARMA LTDNICARDIPINE HYDROCHLORIDE USP

DMF 291982015

SICHUAN QINGMU PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE

DMF 372872022

MSN LABORATORIES PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 375822023

QILU PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE USP

DMF 388762023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE USP

DMF 393262024

MAHI DRUGS PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 400132025

METROCHEM API PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 402352024

MAPRIMED SAInactiveNICARDIPINE HYDROCHLORIDE

DMF 89191991

MITSUBISHI CORPInactiveNICARDIPINE HYDROCHLORIDE

DMF 107021994

DR REDDYS LABORATORIES LTDInactiveNICARDIPINE HYDROCHLORIDE

DMF 220442008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2016	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 21, 1992

No patent or exclusivity listings for this strength.

#002 — 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 21, 1992

#003 — 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 21, 1992