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Last Updated: April 3, 2020

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PROCAINAMIDE HYDROCHLORIDE Drug Profile


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When do Procainamide Hydrochloride patents expire, and when can generic versions of Procainamide Hydrochloride launch?

Procainamide Hydrochloride is a drug marketed by Ani Pharms Inc, Ascot, Ivax Sub Teva Pharms, Lannett, Lederle, Roxane, Vangard, Watson Labs, Abraxis Pharm, Hospira, Intl Medication, Nexus Pharms, Pharmafair, Smith And Nephew, Solopak, Warner Chilcott, West-ward Pharms Int, Inwood Labs, and Sandoz. and is included in fifty-eight NDAs.

The generic ingredient in PROCAINAMIDE HYDROCHLORIDE is procainamide hydrochloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the procainamide hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Procainamide Hydrochloride

A generic version of PROCAINAMIDE HYDROCHLORIDE was approved as procainamide hydrochloride by INTL MEDICATION on July 31st, 1984.

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Drug patent expirations by year for PROCAINAMIDE HYDROCHLORIDE
Recent Clinical Trials for PROCAINAMIDE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jeffrey MoakPhase 4
Oregon Health and Science UniversityPhase 2
University of PittsburghN/A

See all PROCAINAMIDE HYDROCHLORIDE clinical trials

Recent Litigation for PROCAINAMIDE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC2015-03-26

See all PROCAINAMIDE HYDROCHLORIDE litigation

Pharmacology for PROCAINAMIDE HYDROCHLORIDE
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for PROCAINAMIDE HYDROCHLORIDE
Synonyms for PROCAINAMIDE HYDROCHLORIDE
(4-aminophenyl)-N-[2-(diethylamino)ethyl]carboxamide, chloride
4-Amino-N-(2-(diethylamino)ethyl)benzamide hydrochloride
4-Amino-N-(2-(diethylamino)ethyl)benzamide monohydrochloride
4-amino-N-(2-diethylamino-ethyl)-benzamide HCl
4-Amino-N-(2-diethylaminoethyl)benzamide hydrochloride
4-amino-N-[2-(diethylamino)ethyl]-Benzamide hydrochloride
4-amino-N-[2-(diethylamino)ethyl]benzamide hydrochloride
4-amino-N-[2-(diethylamino)ethyl]benzamide;hydrochloride
4-Aminobenzoesaeure-2-diethylaminoethylester hydrochlorid
4-Aminobenzoic acid 2-diethylaminoethylamide
614-39-1
7699-39-0
A14240
ABTXGJFUQRCPNH-UHFFFAOYSA-N
AC-7552
ACT08464
AK133049
AKOS008056264
BCP28404
Benzamide, 4-amino-N-(2-(diethylamino)ethyl)-, hydrochloride (1:1)
Benzamide, 4-amino-N-(2-(diethylamino)ethyl)-, monohydrochloride
Benzamide, 4-amino-N-[2-(diethylamino)ethyl]-, hydrochloride (1:1)
Benzamide, 4-amino-N-[2-(diethylamino)ethyl]-, monohydrochloride
Benzamide, p-amino-N-(2-(diethylamino)ethyl)-, hydrochloride
BIM-0050968.0001
C13H22ClN3O
CAS-614-39-1
CCG-39233
CCRIS 7143
CHEBI:8429
CHEMBL605
CPD000059079
CTK6E8331
D00477
DB-053889
DSSTox_CID_29382
DSSTox_GSID_49422
DSSTox_RID_83497
DTXSID2049422
EBD3071181
EINECS 210-381-7
Epitope ID:140114
EU-0100995
F0850-6742
FT-0603493
HMS1569C15
HMS1920L04
HY-A0084
KS-5258
LP00995
LS-25497
M850
MCULE-9726613752
MFCD00012998
MLS000069436
MLS001148635
NC00535
NCGC00094291-01
NCGC00094291-02
NCGC00094291-03
NCGC00094291-04
NCGC00094291-05
NCGC00260401-01
NCGC00261680-01
NE10724
Novocamid hydrochloride
NSC-757279
NSC757279
Opera_ID_1543
P 9391
p-Amino-N-(2-(diethylamino)ethyl)benzamide hydrochloride
p-Amino-N-(2-(diethylamino)ethyl)benzamide monohydrochloride
Pharmakon1600-01500503
Procainamide (hydrochloride)
Procainamide Hcl
Procainamide HCL USP
Procainamide hydrochloride (JP17/USP)
Procainamide hydrochloride [USAN:JAN]
Procainamide hydrochloride [USP:JAN]
Procainamide hydrochloride, >=98% (HPLC)
Procainamide hydrochloride, 99%
Procainamide hydrochloride, European Pharmacopoeia (EP) Reference Standard
Procainamide hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Procainamide hydrochloride, purum, >=98.0% (AT)
Procainamide hydrochloride, United States Pharmacopeia (USP) Reference Standard
procainamide-hcl
PROCAINAMIDEHYDROCHLORIDE
Procaine amide hydrochloride
Procainhydrochlorid
Procaini hydrochloridum
Procainii chloridum
Procamide hydrochloride
Procan
Procan SR
Procan SR (TN)
Procan-SR hydrochloride
Procanbid
Procanbid (TN)
Procapan
Procapan hydrochloride
Procardyl hydrochloride
Promide hydrochloride
Pronestyl
Pronestyl (TN)
Pronestyl hydrochloride
Pronestyl-Sr
PubChem15966
Q27108080
s4294
SAM002554928
SBB001067
SCHEMBL40758
SI4064O0LX
SMR000059079
SPECTRUM1500503
SR-01000000022
SR-01000000022-2
SR-01000000022-6
ST50319808
Supicane amide hydrochloride
SW196878-3
Tox21_202855
Tox21_500995
TR-034892
UNII-SI4064O0LX
VA11587
VU0239777-5
W-105155

US Patents and Regulatory Information for PROCAINAMIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride INJECTABLE;INJECTION 089528-001 May 3, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Intl Medication PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride INJECTABLE;INJECTION 088636-001 Jul 31, 1984 AP RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 089369-001 Aug 14, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs PROCAINAMIDE HYDROCHLORIDE procainamide hydrochloride TABLET, EXTENDED RELEASE;ORAL 088534-001 Dec 3, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Dow
Harvard Business School
Baxter
McKesson

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