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Last Updated: March 28, 2024

NISOLDIPINE Drug Patent Profile


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Which patents cover Nisoldipine, and when can generic versions of Nisoldipine launch?

Nisoldipine is a drug marketed by Amta and Mylan and is included in three NDAs.

The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nisoldipine

A generic version of NISOLDIPINE was approved as nisoldipine by MYLAN on July 25th, 2008.

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Drug patent expirations by year for NISOLDIPINE
Drug Prices for NISOLDIPINE

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Recent Clinical Trials for NISOLDIPINE

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

SponsorPhase
Menarini International Operations Luxembourg SAPhase 4
Mylan PharmaceuticalsPhase 1
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 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
Amta NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 216606-001 Apr 10, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 091001-004 Jan 26, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-001 Jul 25, 2008 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-003 Jul 25, 2008 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 091001-001 Jan 26, 2011 AB RX 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

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