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Last Updated: March 26, 2023

Diltiazem hydrochloride - Generic Drug Details


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What are the generic 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, Glenmark Pharms Ltd, Mayne Pharma Intl, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Akorn, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Exela Pharma, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Rising, Sciegen Pharms Inc, and Teva Pharms, and is included in fifty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for diltiazem hydrochloride. Forty-five 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
Glenmark Pharms Ltd DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212317-003 Mar 22, 2021 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-004 Feb 6, 2003 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206997-001 Apr 28, 2020 AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Valeant Pharms North DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075116-002 Dec 23, 1999 AB3 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-002 Dec 27, 1991 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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McKesson

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