TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for trandolapril; verapamil hydrochloride and what is the scope of freedom to operate?

Trandolapril; verapamil hydrochloride is the generic ingredient in two branded drugs marketed by Abbvie and Glenmark Pharms Ltd, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
DailyMed Link:	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

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

Sponsor	Phase
Hospital Authority, Hong Kong	Phase 4
Assaf-Harofeh Medical Center
Mario Negri Institute for Pharmacological Research	Phase 3

See all TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE clinical trials

Pharmacology for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Drug Class	Angiotensin Converting Enzyme Inhibitor Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

C08DA	Phenylalkylamine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	1 mg/240 mg	020591	1	2008-02-20
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	2 mg/180 mg and 2 mg/240 mg	020591	1	2007-11-09
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	4 mg/ 240 mg	020591	1	2007-07-24

US Patents and Regulatory Information for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

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	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-002	May 26, 2010		RX	No	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996		DISCN	Yes	No
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-004	Aug 30, 2010		RX	No	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996		DISCN	Yes	No

Expired US Patents for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996