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Last Updated: March 29, 2024

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 Amta, Mylan, and Covis, and is included in four 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

See drug prices for nisoldipine

Recent Clinical Trials for nisoldipine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Menarini International Operations Luxembourg SAPhase 4
Mylan PharmaceuticalsPhase 1
BayerPhase 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 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 020356-003 Feb 2, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-007 Jan 2, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amta NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 216606-001 Apr 10, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-003 Feb 2, 1995 ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-008 Jan 2, 2008 ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-006 Jan 2, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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