CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

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Which patents cover Cardene In 5.0% Dextrose In Plastic Container, and when can generic versions of Cardene In 5.0% Dextrose In Plastic Container launch?

Cardene In 5.0% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 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 In 5.0% Dextrose In Plastic Container

A generic version of CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

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Summary for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
Formulation / Manufacturing:	see details
DailyMed Link:	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Drug patent expirations by year for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Recent Clinical Trials for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

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

Sponsor	Phase
Boston Medical Center	Phase 4
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Cincinnati	Phase 2

See all CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 5.0% 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

Paragraph IV (Patent) Challenges for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	Injection	nicardipine hydrochloride	2.5 mg/mL, 10 mL Ampoules	019734	1	2006-12-27

US Patents and Regulatory Information for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is protected by four US patents.

Patents protecting CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Pre-mixed, ready-to-use pharmaceutical compositions
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Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions
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Patented Use: METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF

Pre-mixed, ready-to-use pharmaceutical compositions
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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
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER around the world.

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Country	Patent Number	Title	Estimated Expiration
Spain	8700567		⤷ Sign Up
Austria	334902		⤷ Sign Up
Japan	S5545075		⤷ Sign Up
China	101484136	Pre-mixed, ready-to-use pharmaceutical compositions	⤷ Sign Up
Japan	S5084577		⤷ Sign Up
Belgium	1003647	COMPOSITION PHARMACEUTIQUE DE NICARDIPINE POUR ADMINISTRATION PARENTERALE.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration