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Last Updated: December 7, 2022

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.

Drug Prices for nisoldipine

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Recent Clinical Trials for nisoldipine

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SponsorPhase
Menarini International Operations Luxembourg SAPhase 4
Mylan PharmaceuticalsPhase 1
Steno Diabetes CenterPhase 4

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Pharmacology for nisoldipine
Medical Subject Heading (MeSH) Categories for nisoldipine
Paragraph IV (Patent) Challenges for NISOLDIPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SULAR Extended-release Tablets nisoldipine 8.5 mg and 17 mg 020356 1 2009-03-02
SULAR Extended-release Tablets nisoldipine 25.5 mg and 34 mg 020356 1 2008-11-28
SULAR Extended-release Tablets nisoldipine 20 mg and 30 mg 020356 1 2007-11-07
SULAR Extended-release Tablets nisoldipine 40 mg 020356 1 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 020356-006 Jan 2, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-001 Feb 2, 1995 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-007 Jan 2, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-003 Jul 25, 2008 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 091001-001 Jan 26, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-002 Jul 25, 2008 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020356-003 Feb 2, 1995 See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-007 Jan 2, 2008 See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008 See Plans and Pricing See Plans and Pricing
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-004 Feb 2, 1995 See Plans and Pricing See Plans and Pricing
>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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