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Last Updated: November 2, 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, Amta, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi 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, 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-two 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
Apothecon DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074051-001 Mar 31, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Edenbridge Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 211596-002 Nov 18, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 216521-002 Sep 23, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 216327-005 Apr 6, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc TAZTIA XT diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075401-001 Apr 10, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 090492-001 Oct 28, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075106-001 Apr 29, 1999 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
Allergan DILACOR XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020092-002 May 29, 1992 ⤷  Sign Up ⤷  Sign Up
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 ⤷  Sign Up ⤷  Sign Up
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-001 Aug 10, 1992 ⤷  Sign Up ⤷  Sign Up
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-004 Jan 23, 1989 ⤷  Sign Up ⤷  Sign Up
Bausch TIAZAC diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020401-006 Oct 16, 1998 ⤷  Sign Up ⤷  Sign Up
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-002 Jan 23, 1989 ⤷  Sign Up ⤷  Sign Up
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-002 Feb 6, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.