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Last Updated: March 19, 2024

Nimodipine - Generic Drug Details


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What are the generic sources for nimodipine and what is the scope of freedom to operate?

Nimodipine is the generic ingredient in three branded drugs marketed by Bionpharma, Heritage Pharms, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, Bayer Pharms, and Azurity, and is included in seven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nimodipine has two patent family members in two countries.

There are eight drug master file entries for nimodipine. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for nimodipine
Drug Prices for nimodipine

See drug prices for nimodipine

Recent Clinical Trials for nimodipine

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

SponsorPhase
Changjiang Shipping General HospitalPhase 3
Guangzhou Red Cross HospitalPhase 3
Linfen Central HospitalPhase 3

See all nimodipine clinical trials

Generic filers with tentative approvals for NIMODIPINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial60MG/10MLSOLUTION;ORAL
⤷  Try a Trial⤷  Try a Trial30MG/5MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nimodipine
Medical Subject Heading (MeSH) Categories for nimodipine
Paragraph IV (Patent) Challenges for NIMODIPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NYMALIZE Oral Solution nimodipine 6 mg/mL 203340 1 2021-11-29

US Patents and Regulatory Information for nimodipine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharms NIMODIPINE nimodipine CAPSULE;ORAL 077811-001 May 2, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bionpharma NIMODIPINE nimodipine CAPSULE;ORAL 076740-001 Jan 17, 2008 AB 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 nimodipine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms NIMOTOP nimodipine CAPSULE;ORAL 018869-001 Dec 28, 1988 ⤷  Try a Trial ⤷  Try a Trial
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 ⤷  Try a Trial ⤷  Try a Trial
Bayer Pharms NIMOTOP nimodipine CAPSULE;ORAL 018869-001 Dec 28, 1988 ⤷  Try a Trial ⤷  Try a Trial
Bayer Pharms NIMOTOP nimodipine CAPSULE;ORAL 018869-001 Dec 28, 1988 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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