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Last Updated: August 3, 2020

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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 freedom to operate?

Diltiazem hydrochloride is the generic ingredient in eleven branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Akorn Inc, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diltiazem hydrochloride has twelve patent family members in eleven countries.

There are twenty-six drug master file entries for diltiazem hydrochloride. Thirty-seven suppliers are listed for this compound.

Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Auckland, New ZealandPhase 2/Phase 3
Tanta UniversityEarly Phase 1
Chugai Pharma ChinaPhase 4

See all DILTIAZEM HYDROCHLORIDE clinical trials

Pharmacology for DILTIAZEM HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-08-30
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-04-25
CARDIZEM SR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 019471
CARDIZEM CD CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020062
DILACOR XR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020092
TIAZAC CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020401

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
Hospira DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075004-001 Feb 16, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074067-003 Nov 5, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex DILTZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076395-001 Feb 1, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
>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
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-004 Sep 11, 1995   Start Trial   Start Trial
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-003 Dec 27, 1991   Start Trial   Start Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-006 Feb 6, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School

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