.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Novartis
Johnson and Johnson
Merck
QuintilesIMS
McKesson
AstraZeneca
US Department of Justice
Mallinckrodt
Chinese Patent Office
Cipla

Generated: November 21, 2017

DrugPatentWatch Database Preview

Nicardipine hydrochloride - Generic Drug Details

« Back to Dashboard

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

Nicardipine hydrochloride
is the generic ingredient in eight branded drugs marketed by Chiesi Usa Inc, Sun Pharma Global, West-ward Pharms Int, Navinta Llc, Epic Pharma, Luitpold Pharms Inc, Ani Pharms Inc, Mylan, Mylan Institutional, Watson Labs, Wockhardt, and Exela Pharma Science, and is included in fifteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-three patent family members in eleven countries.

There are eleven drug master file entries for nicardipine hydrochloride. Sixteen suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-002Jul 31, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Ani Pharms Inc
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074540-002Oct 28, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Institutional
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
INJECTABLE;INJECTION090664-001Nov 17, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
CAPSULE;ORAL019488-001Dec 21, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Epic Pharma
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074928-001Mar 19, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-001Feb 21, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074642-001Jul 18, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe
Epic Pharma
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074928-002Mar 19, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-003Jul 31, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Ani Pharms Inc
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074439-002Dec 10, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: nicardipine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-001Feb 21, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-002Feb 21, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-003Feb 21, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
CAPSULE;ORAL019488-001Dec 21, 1988► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-003Feb 21, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-002Feb 21, 1992► Subscribe► Subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-001Feb 21, 1992► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: nicardipine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,659,290Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions► Subscribe
9,549,994Compositions of nicardipine and sulfoalkylated .beta.-cyclodextrin► Subscribe
9,370,586Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: nicardipine hydrochloride

Country Document Number Estimated Expiration
Mexico2008013405► Subscribe
Australia2007237903► Subscribe
Canada2895102► Subscribe
Japan2009534388► Subscribe
World Intellectual Property Organization (WIPO)2007121483► Subscribe
Canada2649779► Subscribe
European Patent Office2018152► Subscribe
New Zealand572226► Subscribe
World Intellectual Property Organization (WIPO)2007123984► Subscribe
China101484136► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Moodys
Mallinckrodt
Novartis
Federal Trade Commission
Baxter
Chubb
Accenture
McKinsey
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot