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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Dow
Argus Health
Novartis
Healthtrust
Daiichi Sankyo
UBS
McKinsey
Boehringer Ingelheim
Farmers Insurance

Generated: August 18, 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, 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-six 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 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 Generic Name: diltiazem hydrochloride

Tradenames:11
Patents:2
Applicants:28
NDAs:46
Drug Master File Entries: see list26
Suppliers / Packagers: see list45
Bulk Api Vendors: see list50
Clinical Trials: see list2,319
Patent Applications: see list3,510
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:diltiazem hydrochloride at DailyMed

Pharmacology for Ingredient: 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 CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992AB3RXYesNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL090421-004Nov 15, 2010AB4RXNoNo► Subscribe► Subscribe► Subscribe
Biovail
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020939-006Sep 14, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
DILTZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL076395-003Feb 1, 2006AB4RXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
TABLET;ORAL074168-003Mar 3, 1995DISCNNoNo► 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
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-003Jan 23, 1989► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992► Subscribe► Subscribe
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-006Oct 16, 1998► 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;ORAL020062-005Aug 24, 1999► Subscribe► Subscribe
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International Patent Family for Ingredient: diltiazem hydrochloride

Country Document Number Estimated Expiration
Japan3725474► Subscribe
Canada2348953► Subscribe
Spain2325826► 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 500+ biopharmaceutical companies globally:

Citi
QuintilesIMS
Dow
Daiichi Sankyo
Healthtrust
Farmers Insurance
McKesson
Colorcon
Moodys
Queensland Health

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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