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Generated: December 12, 2017

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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-eight 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-seven suppliers are listed for this compound.

Pharmacology for diltiazem hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl IncDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL077686-002Mar 15, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par PharmDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL074984-003Dec 20, 1999AB3RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncDILTZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL076395-005Feb 1, 2006AB4RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApotheconDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideTABLET;ORAL074051-004Mar 31, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL077686-004Mar 15, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
BiovailCARDIZEM SRdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL019471-001Jan 23, 1989DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-006Oct 16, 1998AB4RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Valeant IntlCARDIZEM LAdiltiazem hydrochlorideTABLET, EXTENDED RELEASE;ORAL021392-001Feb 6, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-003Dec 8, 1986ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL074852-002Oct 10, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: diltiazem hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant IntlCARDIZEM CDdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020062-004Dec 27, 1991► Subscribe► Subscribe
Valeant IntlCARDIZEM CDdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Valeant IntlCARDIZEM CDdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 1991► Subscribe► Subscribe
Valeant IntlCARDIZEM CDdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020062-004Dec 27, 1991► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-002Sep 11, 1995► Subscribe► Subscribe
Allergan Sales LlcDILACOR XRdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020092-002May 29, 1992► Subscribe► Subscribe
Allergan Sales LlcDILACOR XRdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020092-003May 29, 1992► Subscribe► Subscribe
Valeant IntlCARDIZEM CDdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Allergan Sales LlcDILACOR XRdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020092-002May 29, 1992► Subscribe► Subscribe
BiovailDILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020939-003Jan 28, 2000► Subscribe► Subscribe
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International Patent Family for Ingredient: diltiazem hydrochloride

Country Document Number Estimated Expiration
Canada2307547► Subscribe
Japan2003509454► Subscribe
World Intellectual Property Organization (WIPO)0141744► Subscribe
Austria430561► Subscribe
United Kingdom9921933► Subscribe
Australia6566700► Subscribe
Japan2003516347► Subscribe
Japan3725474► Subscribe
Canada2566590► Subscribe
Austria293438► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Merck
US Department of Justice
Mallinckrodt
Johnson and Johnson
McKesson
Cipla
Fish and Richardson
Dow
Baxter
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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