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Last Updated: November 21, 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, Apotex, Biovail, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, 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-three 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
Twi Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 217377-001 Mar 1, 2023 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Farmaceutica DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 202651-001 Aug 9, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 075124-003 Mar 18, 1998 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
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-001 Jan 28, 2000 ⤷  Sign Up ⤷  Sign Up
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-002 Jan 28, 2000 ⤷  Sign Up ⤷  Sign Up
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9300093 ⤷  Sign Up
Australia 2243092 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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