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Diltiazem hydrochloride - Generic Drug Details

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Diltiazem hydrochloride is the generic ingredient in eleven branded drugs marketed by Actavis Labs Fl Inc, Valeant Pharms North, Valeant Intl, Hospira, Mylan, Amphastar Pharms Inc, Sun Pharma Global, Sandoz, Biovail Labs Intl, Eurohlth Intl Sarl, 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, Dava Pharms Inc, Teva Pharms Usa, and Apotex Inc, and is included in forty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty 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 Generic Name: diltiazem hydrochloride

Tradenames:11
Patents:2
Applicants:27
NDAs:45
Drug Master File Entries: see list26
Suppliers / Packagers: see list44
Bulk Api Vendors: see list50
Clinical Trials: see list1,008
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: diltiazem hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 1991RXNo► subscribe► subscribe
Biovail
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020939-002Jan 28, 2000DISCNNo► subscribe► subscribe
Biovail
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020939-006Sep 14, 2001DISCNNo► 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;ORAL019471-002Jan 23, 19894,721,619► subscribe
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-002Sep 11, 19955,529,791► subscribe
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-004Jan 23, 19894,721,619► subscribe
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International Patent Family for Ingredient: diltiazem hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0121155► subscribe
Canada2307547► subscribe
Portugal1131057► 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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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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