CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

When do Cardene In 4.8% Dextrose In Plastic Container patents expire, and when can generic versions of Cardene In 4.8% Dextrose In Plastic Container launch?

Cardene In 4.8% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene In 4.8% Dextrose In Plastic Container

A generic version of CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	8
Formulation / Manufacturing:	see details
DailyMed Link:	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

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

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

See all CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

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 IN 4.8% DEXTROSE IN PLASTIC CONTAINER

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 IN 4.8% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is protected by six US patents.

Patents protecting CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y

International Patents for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	543343
Mexico	2008013407	COMPOSICIONES DE BOLO IV PREMEZCLADAS, LISTAS PARA USO Y METODOS DE USO. (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE.)
Japan	S5084576
Japan	S49109384
Canada	1023746	2,6-DIMETHYL-4-PHENYL-1,4-DIHYDROPYRIDINES
Norway	143846
Canada	2650922	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)