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Nicardipine hydrochloride - Generic Drug Details

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Nicardipine hydrochloride is the generic ingredient in seven branded drugs marketed by Chiesi Usa Inc, Sun Pharma Global, Eurohlth Intl Sarl, 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.

This ingredient has twenty-three patent family members in eleven countries.

There are eleven drug master file entries for nicardipine hydrochloride. Seventeen suppliers are listed for this compound.

Summary for Generic Name: nicardipine hydrochloride

Tradenames:7
Patents:4
Applicants:12
NDAs:15
Drug Master File Entries: see list11
Suppliers / Packaging: see list17
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: nicardipine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms Inc
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
CAPSULE;ORAL074439-001Dec 10, 1996RXNo► subscribe► subscribe
Chiesi Usa Inc
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-002Jul 31, 2008RXYes8,455,524► subscribe ► subscribe
Chiesi Usa Inc
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS019734-004Nov 7, 2008RXYes8,455,524► subscribe ► subscribe
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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, 19923,985,758► subscribe
Chiesi Usa Inc
CARDENE SR
nicardipine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020005-003Feb 21, 19923,985,758► subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
CAPSULE;ORAL019488-001Dec 21, 19883,985,758► subscribe
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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
9,370,586Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions► subscribe
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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.

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International Patent Family for Ingredient: nicardipine hydrochloride

Country Document Number Estimated Expiration
Mexico2008013405► subscribe
China101484006► subscribe
China101484136► subscribe
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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.

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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.

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