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, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Exela Pharma, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for diltiazem hydrochloride. Fifty-two suppliers are listed for this compound.

Summary for diltiazem hydrochloride

US Patents:	0
Tradenames:	12
Applicants:	38
NDAs:	62
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	106
Patent Applications:	4,517
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diltiazem hydrochloride
What excipients (inactive ingredients) are in diltiazem hydrochloride?	diltiazem hydrochloride excipients list
DailyMed Link:	diltiazem hydrochloride at DailyMed

Recent Clinical Trials for diltiazem hydrochloride

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

Sponsor	Phase
Ascension Genesys Hospital	Phase 2
Aurora Health Care	Phase 4
Hospices Civils de Lyon	Phase 2

See all diltiazem hydrochloride clinical trials

Pharmacology for diltiazem hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for diltiazem hydrochloride

C05AE	Muscle relaxants
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

C08DB	Benzothiazepine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	074051-001	Mar 31, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Edenbridge Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	211596-002	Nov 18, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	216521-002	Sep 23, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216327-005	Apr 6, 2023	AB	RX	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

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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	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	⤷ Sign Up	⤷ Sign Up
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-004	Jan 23, 1989	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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