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Last Updated: March 6, 2021

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Nisoldipine - Generic Drug Details

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What are the generic drug sources for nisoldipine and what is the scope of patent protection?

Nisoldipine is the generic ingredient in two branded drugs marketed by Mylan and Covis, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nisoldipine. Three suppliers are listed for this compound.

Summary for nisoldipine
Drug Prices for nisoldipine

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Recent Clinical Trials for nisoldipine

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SponsorPhase
Mylan PharmaceuticalsPhase 1
BayerPhase 4
Steno Diabetes CenterPhase 4

See all nisoldipine clinical trials

Pharmacology for nisoldipine
Medical Subject Heading (MeSH) Categories for nisoldipine
Paragraph IV (Patent) Challenges for NISOLDIPINE
Tradename Dosage Ingredient NDA Submissiondate
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2009-03-02
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2008-11-28
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2007-11-07
SULAR TABLET, EXTENDED RELEASE;ORAL nisoldipine 020356 2007-06-11

US Patents and Regulatory Information for nisoldipine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-005 Jan 2, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 091001-001 Jan 26, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 091001-003 Jan 26, 2011 RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nisoldipine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995   Start Trial   Start Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-002 Feb 2, 1995   Start Trial   Start Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
McKesson
Merck
Johnson and Johnson
Harvard Business School

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