TRANDOLAPRIL - Generic Drug Details

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

Trandolapril is the generic ingredient in four branded drugs marketed by Abbvie, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Norvium Bioscience, Teva Pharms, Watson Labs, and Glenmark Pharms Ltd, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for trandolapril. Five suppliers are listed for this compound.

Summary for TRANDOLAPRIL

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	18
Patent Applications:	6,366
Drug Prices:	Drug price trends for TRANDOLAPRIL
What excipients (inactive ingredients) are in TRANDOLAPRIL?	TRANDOLAPRIL excipients list
DailyMed Link:	TRANDOLAPRIL at DailyMed

See drug prices for TRANDOLAPRIL

Recent Clinical Trials for TRANDOLAPRIL

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

Sponsor	Phase
University of Nebraska	Phase 4
Hospital Authority, Hong Kong	Phase 4
Assaf-Harofeh Medical Center

See all TRANDOLAPRIL clinical trials

Pharmacology for TRANDOLAPRIL

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRANDOLAPRIL

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAVIK	Tablets	trandolapril	1 mg, 2 mg and 4 mg	020528	1	2004-10-04

US Patents and Regulatory Information for TRANDOLAPRIL

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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
Dr Reddys Labs Ltd	TRANDOLAPRIL	trandolapril	TABLET;ORAL	078493-002	Aug 25, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-004	Aug 30, 2010		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	TRANDOLAPRIL	trandolapril	TABLET;ORAL	077489-002	Dec 12, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	TRANDOLAPRIL	trandolapril	TABLET;ORAL	077489-001	Dec 12, 2006		DISCN	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 TRANDOLAPRIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-001	Apr 26, 1996	⤷ Sign Up	⤷ Sign Up
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-002	Apr 26, 1996	⤷ Sign Up	⤷ Sign Up
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-002	Apr 26, 1996	⤷ Sign Up	⤷ Sign Up
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-003	Apr 26, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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