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Diltiazem hydrochloride - Generic Drug Details
What are the generic drug sources for diltiazem hydrochloride and what is the scope of freedom to operate?
Diltiazem hydrochloride
is the generic ingredient in eleven branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan Sales Llc, Apotex, Actavis Elizabeth, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Apotex Inc, Biovail Labs Intl, 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 fifty-one 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-four suppliers are listed for this compound.
Summary for diltiazem hydrochloride
| International Patents: | 22 |
| US Patents: | 2 |
| Tradenames: | 11 |
| Applicants: | 30 |
| NDAs: | 51 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 44 |
| Bulk Api Vendors: | 92 |
| Clinical Trials: | 83 |
| Patent Applications: | 3,905 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diltiazem hydrochloride |
| DailyMed Link: | diltiazem hydrochloride at DailyMed |
Recent Clinical Trials for diltiazem hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Abderrahmane Mami Hospital | Phase 2 |
| Temple University | Phase 4 |
| Veloxis Pharmaceuticals | Phase 4 |
Recent Litigation for diltiazem hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
Pharmacology for diltiazem hydrochloride
| Drug Class | Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biovail Labs Intl | CARDIZEM | diltiazem hydrochloride | INJECTABLE;INJECTION | 020027-003 | Aug 18, 1995 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan Sales Llc | DILACOR XR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020092-002 | May 29, 1992 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Apotex Inc | DILTZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 076395-003 | Feb 1, 2006 | AB4 | 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 |
|---|---|---|---|---|---|---|---|
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-001 | Feb 6, 2003 | Start Trial | Start Trial |
| Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-001 | Jan 23, 1989 | Start Trial | Start Trial |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diltiazem hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0121155 | Start Trial |
| Japan | 2003509454 | Start Trial |
| Denmark | 1131057 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.