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Last Updated: November 21, 2024

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 twelve branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Exela Pharma, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for diltiazem hydrochloride. Fifty-three suppliers are listed for this compound.

Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE

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

SponsorPhase
Ascension Genesys HospitalPhase 2
Aurora Health CarePhase 4
Hospices Civils de LyonPhase 2

See all DILTIAZEM HYDROCHLORIDE clinical trials

Pharmacology for DILTIAZEM HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CARDIZEM LA Extended-release Tablets diltiazem hydrochloride 120 mg, 180 mg, 240 mg, 300 mg and 360 mg 021392 1 2005-08-30
CARDIZEM LA Extended-release Tablets diltiazem hydrochloride 420 mg 021392 1 2005-04-25

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
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-001 Sep 11, 1995 AB4 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-004 Feb 6, 2003 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apothecon DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074051-002 Mar 31, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Edenbridge Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 211596-004 Nov 18, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-003 Sep 11, 1995 ⤷  Sign Up ⤷  Sign Up
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-003 Dec 27, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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