Diltiazem hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

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, 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-five 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:	45
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	106
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
Ascension Genesys Hospital	Phase 2
Aurora Health Care	Phase 4
Signia Therapeutics	Phase 2

See all diltiazem hydrochloride clinical trials

Pharmacology for diltiazem hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Glenmark Pharms Ltd	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212317-003	Mar 22, 2021	AB1	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Accord Hlthcare	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206997-001	Apr 28, 2020	AB2	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Valeant Pharms North	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	075116-002	Dec 23, 1999	AB3	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

Subscribe to access the full database, or Try a Trial
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	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
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991	See Plans and Pricing	See Plans and Pricing
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.