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Last Updated: December 11, 2019

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DILTIAZEM HYDROCHLORIDE Drug Profile

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When do Diltiazem Hydrochloride patents expire, and what generic alternatives are available?

Diltiazem Hydrochloride is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Akorn Inc, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, and Teva Pharms. and is included in thirty-nine NDAs.

The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

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

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

SponsorPhase
American University of Beirut Medical CenterPhase 2
Mercy Health MuskegonPhase 4
Stanford UniversityPhase 2

See all DILTIAZEM HYDROCHLORIDE clinical trials

Recent Litigation for DILTIAZEM HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Takeda Pharmaceutical Co v. Impax Laboratories, Inc.2013-11-19
Takeda Pharmaceutical Co., Ltd. v. Impax Laboratories, Inc.2011-04-01

See all DILTIAZEM HYDROCHLORIDE litigation

Pharmacology for DILTIAZEM HYDROCHLORIDE
Synonyms for DILTIAZEM HYDROCHLORIDE
(+)-5-(2-(Dimethylamino)ethyl)-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate (ester) monohydrochloride
(+)-5-(2-(dimethylamino)ethyl)-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate ester monohydrochloride
(+)-cis-Diltiazem hydrochloride
(+)-cis-Diltiazem hydrochloride, >=99% (HPLC)
(2R-trans)-Diltiazem Hydrochloride
(2S-?trans)?-diltiazem hydrochloride
(2S-cis)-3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one hydrochloride
(2S-cis)-3-Acetoxy-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one monohydrochloride
(2S-trans)-Diltiazem Hydrochloride
(2S,3S)-(+)-3-Acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one Hydrochloride
(2S,3S)-(+)-cis-3-Acetoxy-5-(2-dimethylaminoethyl)-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one hydrochloride
(2S,3S)-5-(2-(dimethylamino)ethyl)-2
(2S,3S)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl acetate hydrochloride
(2S,3S)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate hydrochloride
(2S,3S)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2H,3H-benzo[b]1,4 -thiazaperhydroepin-3-yl acetate, chloride
[(2S,3S)-5-(2-dimethylaminoethyl)-2-(4-methoxyphenyl)-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] acetate hydrochloride
[(2S,3S)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] acetate;hydrochloride
1,5-Benzothiazepin-4(5H)-one, 2,3-dihydro-3-(acetyloxy)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-, monohydrochloride, cis-(+)-
1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-
103532-26-9
2-[(2S,3S)-3-(acetyloxy)-2-(4-methoxyphenyl)-4-oxo-3,4-dihydro-1,5-benzothiazepin-5(2H)-yl]-N,N-dimethylethanaminium chloride
286D225
33286-22-5
38411-61-9
AB2000340
AC-15189
AC1L1Y1J
AC1Q3C2G
AC1Q3EQ4
acetate hydrochloride
Acetic acid (2S,3S)-5-(2-dimethylamino-ethyl)-2-(4-methoxy-phenyl)-4-oxo-2,3,4,5-tetrahydro-benzo[b][1,4]thiazepin-3-yl ester; hydrochloride
ACT02682
Adizem
Adizem-CD
AKOS015961992
Altiazem
Altiazem Retard
Altiazem RR
Anginyl
Angiotrofin
Angiotrofin Retard
Angitil
Angizem
Anzem
Apo-diltiazem
AS-13703
BC208729
BCP13814
Bi-Tildiem
BIM-0050315.0001
BNP-32762
Britiazim
Bruzem
C22H26N2O4S.HCl
Calcicard
Calnurs
Cardiazem
Cardil
Cardil Retard
Cardizem (TN)
Cardizem CD
Cardizem LA
Cardizem Retard
Cardizem SR
Cardizem XL
Cardizem;Tiazac
Carex
Cartia XT
Cartia XT (TN)
Carzem
Carzen
CCG-220134
CCG-221631
CHEBI:645509
CHEMBL1697
Cirilen
Cirilen AP
cis-(+)-3-acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-1,5-benzothiazepine-4(5H)-one hydrochloride
cis-(1)-3-Acetoxy-5-(2-(dimethylamino)ethyl)-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one monohydrochloride
Citizen
Clarute
Coras
Corazet
CPD000058375
CRD 401
CRD-401
CS-2339
CTK8E8855
D 2521
D00616
D3662
Dazil
Deltazen
Diacor
Diatal
Dil-Sonaramia
Dilacor
Dilacor XR (TN)
Dilacor XR Extended Release Capsules
Diladel
Dilatam
Dilatam 120
Dilatame
Dilcard
Dilem
Dilfar
Dilgard
Dilicardin
Dilpral
Dilren
Dilrene
Dilsal
Dilso
Dilt-CD (TN)
Dilt-XR
Diltahexal
Diltam
Diltan
Diltan SR
Diltelan
Dilthiazem hydrochloride
Diltia XT
Diltiasyn
Diltiazem (hydrochloride)
Diltiazem AWD
Diltiazem Basics
Diltiazem chloridrate
Diltiazem Eu Rho
Diltiazem for system suitability, European Pharmacopoeia (EP) Reference Standard
Diltiazem GNR
Diltiazem HCl
Diltiazem HCl (Tiazac)
Diltiazem Henning
Diltiazem hydrochloride (JP17/USP)
Diltiazem hydrochloride [USAN:JAN]
Diltiazem hydrochloride [USAN:USP:JAN]
Diltiazem Hydrochloride 1.0 mg/ml in Acetonitrile (as free base)
Diltiazem hydrochloride solution, 1.0 mg/mL in acetonitrile (as free base), ampule of 1 mL, certified reference material
Diltiazem hydrochloride, 98%
Diltiazem hydrochloride, European Pharmacopoeia (EP) Reference Standard
Diltiazem hydrochloride, United States Pharmacopeia (USP) Reference Standard
Diltiazem Hydrochloride,(S)
Diltiazem Merck
Diltiazem MSD
Diltiazem Stada
Diltiazem UPSA
Diltiazem Verla
Diltiazem-Cophar
Diltiazem-GRY
Diltiazem-Isis
Diltiazem-Mepha
Diltiazem, Hydrochloride
Diltikor
Diltime
Dilzem
Dilzem Retard
Dilzem RR
Dilzene
Dilzereal 90 Retard
Dilzicardin
Dinisor
Dinisor Retard
Doclis
Dodexen
Dodexen A.P
Dodexen A.P.
Dolizem
DOV diltiazem
DTXSID8040147
Dyalac
EINECS 251-443-3
EINECS 253-918-0
Entrydil
Etizen
Etyzen
EU-0100327
Farmabes
FT-0625017
FT-0667217
Gadoserin
Hart
HDRXZJPWHTXQRI-BHDTVMLSSA-N
Helsibon
Herben
Herbesser
Herbesser 180 SR
Herbesser 60
Herbesser 90 SR
Hesor
HMS1568K10
HY-14656
Incoril
Iski
Iski-90 SR
J-019130
J10138
Jsp006114
Kaltiazen
Kardil
KS-5089
Lacerol
Levozem
Longazem
LP00327
LS-40513
Lytelsen
Masdil
Metazem
MFCD00069252
Milptin
Miocardie
MK-793
MLS000028432
MLS001148257
MLS002222179
MolPort-003-931-523
Mono-Tildiem
Myonil
Myonil Retard
NC00558
NCGC00093768-01
NCGC00261012-01
NE54505
Novo-Diltazem
OLH94387TE
Opera_ID_79
Oxycardil
Pazeadin
Pentilzeno
Poltiazem
Presoken
Presokin A. P
Presokin A. P.
Prestwick_176
RG 83606
RG 83606 HCl
RG-83606
RT-014406
s1865
SAM002564204
SC-18679
SCHEMBL15457
Slozem
Slozen
SLV-324
SMR000058375
SR-01000003042
SR-01000003042-2
SR-01000003042-4
SR-01000075327
SR-01000075327-1
ST24046586
ST50320016
Surazem
SW196487-3
Syn-Diltiazem
Tazem
Taztia XT
tetrahydrobenzo[b][1,4]thiazepin-3-yl
Tiadil
Tiaves
Tiazac
Tiazac extended release
Tiazac XC
Tilazem
Tilazem 90
Tilazem AS 60
Tilazem AS 90
Tildiem
Tildiem CR
Tildiem LA
Tildiem Retard
Tox21_500327
Trumsal
Ubicor
Uni Masdil
Uni-Masdil
UNII-OLH94387TE
VEN-307
Viazem SR
Viazem XL
WL Diltiazem
Zildem
Zilden
Ziruvate
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-08-30
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-04-25
CARDIZEM SR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 019471
CARDIZEM CD CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020062
DILACOR XR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020092
TIAZAC CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020401

US Patents and Regulatory Information for DILTIAZEM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206534-001 Aug 8, 2017 AB3 RX No No   Start Trial   Start Trial   Start Trial
Apothecon DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074051-002 Mar 31, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091022-003 Sep 28, 2012 AB4 RX No No   Start Trial   Start Trial   Start Trial
Novast Labs DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208783-004 Jun 14, 2019 AB3 RX No No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 202651-001 Aug 9, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 072838-002 Nov 5, 1992 AB RX 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

Expired US Patents for DILTIAZEM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-004 Jan 28, 2000   Start Trial   Start Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000   Start Trial   Start Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-004 Jan 28, 2000   Start Trial   Start Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000   Start Trial   Start Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-002 Jan 28, 2000   Start Trial   Start Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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