Diltiazem hydrochloride - Generic Drug Details

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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.

Summary for diltiazem hydrochloride

US Patents:	0
Tradenames:	12
Applicants:	37
NDAs:	58
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	103
Patent Applications:	4,291
Formulation / Manufacturing:	see details
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
Signia Therapeutics	Phase 2
Hospices Civils de Lyon	Phase 2
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)	Phase 4

See all diltiazem hydrochloride clinical trials

Pharmacology for diltiazem hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

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
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

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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

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