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Federal Trade Commission
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Generated: August 20, 2018

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Diltiazem hydrochloride - Generic Drug Details

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What are the generic drug sources for diltiazem hydrochloride and what is the scope of diltiazem hydrochloride freedom to operate?

Diltiazem hydrochloride is the generic ingredient in eleven branded drugs marketed by Valeant Intl, Biovail, Actavis Labs Fl Inc, Allergan Sales Llc, Apotex, Actavis Elizabeth, Mylan, Nesher Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Sun Pharma Global, Teva, Valeant Pharms North, Zydus Pharms Usa Inc, Apotex Inc, Biovail Labs Intl, Akorn Inc, Athenex Inc, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, Apothecon, Chartwell Molecules, Ivax Sub Teva Pharms, and Teva Pharms, and is included in forty-nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diltiazem hydrochloride has twenty-two patent family members in eleven countries.

There are twenty-six drug master file entries for diltiazem hydrochloride. Forty-five suppliers are listed for this compound.

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)
(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-(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
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-CD
AK162004
AKOS015961992
Altiazem
Altiazem Retard
Altiazem RR
Anginyl
Angiotrofin
Angiotrofin Retard
Angitil
Angizem
Anzem
Apo-diltiazem
AS-13703
BC208729
Bi-Tildiem
BIM-0050315.0001
BNP-32762
Britiazim
Bruzem
C22H26N2O4S.HCl
Calcicard
Calnurs
Cardiazem
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 XR (TN)
Dilacor XR Extended Release Capsules
Diladel
Dilatam
Dilatam 120
Dilatame
Dilcard
Dilem
Dilfar
Dilgard
Dilicardin
Dilpral
Dilrene
Dilsal
Dilso
Dilt-CD (TN)
Dilt-XR
Diltahexal
Diltam
Diltan
Diltan SR
Diltelan
Dilthiazem hydrochloride
Dilthiazemhydrochloride
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, European Pharmacopoeia (EP) Reference Standard
Diltiazem hydrochloride, United States Pharmacopeia (USP) Reference Standard
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
HE005229
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-01000075327
SR-01000075327-1
ST24046586
ST50320016
Surazem
Syn-Diltiazem
Tazem
Taztia XT
Tiadil
Tiaves
Tiazac
Tiazac extended release
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

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
Sun Pharm Inds Ltd DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203023-003 Jun 8, 2017 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc DILTZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076395-004 Feb 1, 2006 AB4 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms North TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-003 Sep 11, 1995 AB4 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc TAZTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075401-001 Apr 10, 2003 AB4 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nesher Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076563-005 Sep 12, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074845-001 Sep 15, 1999 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc CARTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074752-002 Jul 9, 1998 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for diltiazem hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-005 Aug 24, 1999 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-006 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-002 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-003 Dec 8, 1986 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-003 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-002 Dec 27, 1991 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-005 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for diltiazem hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO) 0141744 ➤ Sign Up
Canada 2348953 ➤ Sign Up
Austria 293438 ➤ Sign Up
Germany 60019550 ➤ Sign Up
Austria 430561 ➤ Sign Up
Australia 6566700 ➤ Sign Up
World Intellectual Property Organization (WIPO) 0121155 ➤ Sign Up
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Deloitte
Healthtrust
Colorcon
Argus Health
Farmers Insurance
Teva
Accenture
Covington

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