You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

Diltiazem hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, West-ward Pharms Int, 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. Forty-nine suppliers are listed for this compound.

Summary for diltiazem hydrochloride

US Patents:	0
Tradenames:	12
Applicants:	37
NDAs:	62
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	106
Patent Applications:	4,517
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
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

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
Mylan	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074910-003	May 2, 1997	AB1	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995	AB4	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Valeant Pharms North	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	075116-004	Dec 23, 1999	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Exela Pharma	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	diltiazem hydrochloride	SOLUTION;INTRAVENOUS	215252-001	Oct 28, 2021		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090492-003	Oct 28, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Labs Fl Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077686-001	Mar 15, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	⤷ Try a Trial	⤷ Try a Trial
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-001	Sep 11, 1995	⤷ Try a Trial	⤷ Try a Trial
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995	⤷ Try a Trial	⤷ Try a Trial
Biovail	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020939-001	Jan 28, 2000	⤷ Try a Trial	⤷ Try a Trial
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995	⤷ Try a Trial	⤷ Try a Trial
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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.