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Last Updated: March 19, 2024

DILTIAZEM HYDROCHLORIDE Drug Patent Profile


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Which patents cover Diltiazem Hydrochloride, and what generic alternatives are available?

Diltiazem Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Amta, Apotex, Biovail, 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, Dr Reddys, Eugia Pharma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, West-ward Pharms Int, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, and Exela Pharma. and is included in fifty NDAs.

The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diltiazem Hydrochloride

A generic version of DILTIAZEM HYDROCHLORIDE was approved as diltiazem hydrochloride by TEVA on May 31st, 1995.

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Drug patent expirations by year for DILTIAZEM HYDROCHLORIDE
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
Teva DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074079-001 Nov 30, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 074941-001 Apr 15, 1998 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208783-001 Jun 14, 2019 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075124-002 Mar 18, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET;ORAL 074067-001 Nov 5, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms North DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075116-004 Dec 23, 1999 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 077686-002 Mar 15, 2010 AB RX 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
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-004 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-004 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-002 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DILTIAZEM HYDROCHLORIDE

See the table below for patents covering DILTIAZEM HYDROCHLORIDE around the world.

Country Patent Number Title Estimated Expiration
Germany 69229949 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9300093 ⤷  Try a Trial
European Patent Office 0591424 DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM) ⤷  Try a Trial
Austria 184196 ⤷  Try a Trial
Canada 2111085 FORMULATION DE DILTIAZEM A LIBERATION LENTE (EXTENDED-RELEASE FORM OF DILTIAZEM) ⤷  Try a Trial
Australia 2243092 ⤷  Try a Trial
Denmark 0591424 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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