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Last Updated: March 28, 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 patent protection?

Diltiazem hydrochloride is the generic ingredient in twelve branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Amta, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, West-ward Pharms Int, Exela Pharma, 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 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
Signia TherapeuticsPhase 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
Twi Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 217377-001 Mar 1, 2023 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amta DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 216304-003 Aug 8, 2022 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 216521-002 Sep 23, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203023-002 Jun 8, 2017 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Molecules DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074093-004 Nov 5, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-001 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-003 Dec 27, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-002 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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