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Generated: November 19, 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 Actavis Labs Fl Inc, Valeant Pharms North, Valeant Intl, Hospira, Mylan, Athenex Inc, Sun Pharma Global, Sandoz, Sun Pharm Inds Ltd, Biovail Labs Intl, Zydus Pharms Usa Inc, West-ward Pharms Int, Biovail, Apotex, Intl Medication, Hikma Farmaceutica, Apothecon, Actavis Elizabeth, Nesher Pharms, Teva Pharms, Ivax Sub Teva Pharms, Mylan Labs Ltd, Teva, Par Pharm, Akorn Inc, Allergan Sales Llc, Chartwell Molecules, Teva Pharms Usa, and Apotex Inc, 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-eight 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 Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206534-005Aug 8, 2017AB3RXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL202463-001Dec 7, 2012AB3RXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL074852-002Oct 10, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL075116-001Dec 23, 1999AB3RXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
TABLET;ORAL074067-002Nov 5, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
TABLET;ORAL074185-001May 31, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
Nesher Pharms
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL076563-005Sep 12, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
INJECTABLE;INJECTION074894-001Aug 26, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Chartwell Molecules
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
TABLET;ORAL074093-003Nov 5, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Biovail
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL074845-001Sep 15, 1999DISCNNoNo► 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 Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-001Nov 5, 1982► Subscribe► Subscribe
Allergan Sales Llc
DILACOR XR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020092-003May 29, 1992► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Biovail
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020939-004Jan 28, 2000► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-005Feb 6, 2003► Subscribe► Subscribe
Allergan Sales Llc
DILACOR XR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020092-001May 29, 1992► Subscribe► Subscribe
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-001Jan 23, 1989► Subscribe► Subscribe
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International Patent Family for Ingredient: diltiazem hydrochloride

Country Document Number Estimated Expiration
Canada2566590► Subscribe
Austria293438► Subscribe
Germany60019550► Subscribe
European Patent Office1235562► Subscribe
Austria430561► Subscribe
Japan2003516347► Subscribe
Canada2348953► Subscribe
Denmark1131057► Subscribe
United Kingdom9921933► Subscribe
Spain2241637► 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:

Cipla
Chinese Patent Office
Fuji
Teva
Mallinckrodt
Chubb
McKesson
Medtronic
Boehringer Ingelheim
Moodys

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