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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Queensland Health
Chubb
Julphar
Argus Health
Deloitte
Accenture
Merck
Johnson and Johnson

Generated: February 22, 2018

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Nicardipine hydrochloride - Generic Drug Details

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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, Ani Pharms Inc, Epic Pharma, Mylan, Watson Labs, Exela Pharma Science, Luitpold Pharms Inc, Mylan Institutional, Navinta Llc, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, 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. Fourteen suppliers are listed for this compound.
Summary for nicardipine hydrochloride

US Patents and Regulatory Information for nicardipine hydrochloride

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;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-002 Jul 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Chiesi Usa Inc CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-004 Nov 7, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074670-002 Oct 28, 1996 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Exela Pharma Science NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE nicardipine hydrochloride INJECTABLE;INTRAVENOUS 022276-003 Apr 7, 2016 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 078714-001 Dec 28, 2009 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-005 Nov 7, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nicardipine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride CAPSULE;ORAL 019488-001 Dec 21, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE nicardipine hydrochloride INJECTABLE;INJECTION 019734-001 Jan 30, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-003 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-001 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc CARDENE SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020005-002 Feb 21, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,659,290 Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions ➤ Try a Free Trial
9,370,586 Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions ➤ Try a Free Trial
9,549,994 Compositions of nicardipine and sulfoalkylated .beta.-cyclodextrin ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for nicardipine hydrochloride

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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Federal Trade Commission
Accenture
Johnson and Johnson
Boehringer Ingelheim
Fuji
QuintilesIMS
AstraZeneca
Citi

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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