Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Harvard Business School
Medtronic
Moodys
Dow

Last Updated: December 3, 2022

Diltiazem hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic 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, 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-two suppliers are listed for this compound.

Recent Clinical Trials for diltiazem hydrochloride

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

SponsorPhase
Signia TherapeuticsPhase 2
Hospices Civils de LyonPhase 2
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)Phase 4

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 CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-005 Feb 6, 2003 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nesher Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076563-006 Sep 12, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074185-004 May 31, 1995 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amta DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 216304-001 Aug 8, 2022 AB2 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
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-004 Jan 23, 1989 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-001 Nov 5, 1982 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
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
Harvard Business School
AstraZeneca
Johnson and Johnson
Express Scripts

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.