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Last Updated: August 5, 2021

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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 eleven branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Glenmark Pharms Ltd, 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, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in fifty-four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diltiazem hydrochloride has twelve patent family members in eleven countries.

There are twenty-six drug master file entries for diltiazem hydrochloride. Thirty-nine suppliers are listed for this compound.

Recent Clinical Trials for diltiazem hydrochloride

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

SponsorPhase
University of CalgaryPhase 2/Phase 3
National Cancer Institute, EgyptEarly Phase 1
BeiGenePhase 1

See all diltiazem hydrochloride clinical trials

Pharmacology for diltiazem hydrochloride
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-08-30
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-04-25
TIAZAC CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020401
CARDIZEM SR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 019471
CARDIZEM CD CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020062
DILACOR XR CAPSULE, EXTENDED RELEASE;ORAL diltiazem hydrochloride 020092

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
Zydus Pharms DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206534-002 Aug 8, 2017 AB3 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Pharms Ltd DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212317-003 Mar 22, 2021 AB1 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Labs Fl Inc DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074852-003 Oct 10, 1997 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Intl Medication DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 075749-001 Nov 21, 2001 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride INJECTABLE;INJECTION 074894-001 Aug 26, 1997 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 074943-002 Dec 19, 2000 AB2 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-003 Dec 27, 1991 ⤷  Try it Free ⤷  Try it Free
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-003 Dec 8, 1986 ⤷  Try it Free ⤷  Try it Free
Allergan DILACOR XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020092-001 May 29, 1992 ⤷  Try it Free ⤷  Try it Free
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-001 Aug 10, 1992 ⤷  Try it Free ⤷  Try it Free
Biovail DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020939-003 Jan 28, 2000 ⤷  Try it Free ⤷  Try it Free
Bausch CARDIZEM CD diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020062-004 Dec 27, 1991 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
McKinsey
Merck
Moodys
McKesson

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