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Diltiazem hydrochloride - Generic Drug Details
What are the generic sources for diltiazem hydrochloride and what is the scope of diltiazem hydrochloride patent protection?
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, Twi Pharms, 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 fifty 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.
Summary for diltiazem hydrochloride
| International Patents: | 22 |
| US Patents: | 2 |
| Tradenames: | 11 |
| Applicants: | 30 |
| NDAs: | 50 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 79 |
| Patent Applications: | 3,660 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diltiazem hydrochloride |
| DailyMed Link: | diltiazem hydrochloride at DailyMed |
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) |
| (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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Intl | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Par Pharm | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074984-003 | Dec 20, 1999 | AB3 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Zydus Pharms Usa Inc | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206641-005 | Aug 11, 2017 | AB4 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Valeant Intl | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-002 | Nov 5, 1982 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Valeant Intl | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-005 | Feb 6, 2003 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| 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 |
|---|---|---|---|---|---|---|---|
| Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-004 | Dec 27, 1991 | ➤ 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 LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-002 | Feb 6, 2003 | ➤ Sign Up | ➤ Sign Up |
| Valeant Intl | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-005 | 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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for diltiazem hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 60042168 | ➤ Sign Up |
| Australia | 6566700 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 0141744 | ➤ Sign Up |
| Japan | 2003516347 | ➤ Sign Up |
| Canada | 2348953 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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