You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 1, 2024

Nisoldipine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 020356-004 Feb 2, 1995 DISCN Yes 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 091001-004 Jan 26, 2011 AB RX No No ⤷  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
Mylan NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051-003 Jul 25, 2008 RX No Yes ⤷  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 020356-002 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 020356-001 Feb 2, 1995 ⤷  Try a Trial ⤷  Try a Trial
Covis SULAR nisoldipine TABLET, EXTENDED RELEASE;ORAL 020356-005 Jan 2, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.