CARDENE Drug Patent Profile

Which patents cover Cardene, and when can generic versions of Cardene launch?

Cardene is a drug marketed by Chiesi and is included in three NDAs. There are six patents protecting this drug.

The generic ingredient in CARDENE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene

A generic version of CARDENE was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	173
Clinical Trials:	8
Patent Applications:	3,751
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CARDENE
What excipients (inactive ingredients) are in CARDENE?	CARDENE excipients list
DailyMed Link:	CARDENE at DailyMed

See drug prices for CARDENE

Recent Clinical Trials for CARDENE

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Cincinnati	Phase 2

See all CARDENE clinical trials

Pharmacology for CARDENE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CARDENE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for CARDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988		DISCN	Yes	No
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No			Y
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008		RX	Yes	Yes

Expired US Patents for CARDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992

International Patents for CARDENE

See the table below for patents covering CARDENE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S49108082
Japan	S60246313	INJECTION OF NICARDIPINE HYDROCHLORIDE AND ITS PREPARATION
Japan	S5930704
Canada	1023746	2,6-DIMETHYL-4-PHENYL-1,4-DIHYDROPYRIDINES
European Patent Office	0162705	INJECTION OF NICARDIPINE HYDROCHLORIDE AND PRODUCTION THEREOF
Canada	2011063	COMPOSE PHARMACEUTIQUE DE NICARDIPINE POUR ADMINISTRATION PARENTERALE (NICARDIPINE PHARMACEUTICAL COMPOSITION FOR PARENTERAL ADMINISTRATION)
Netherlands	7402277