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Last Updated: March 5, 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 seven 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
Weihai Municipal HospitalPhase 3
Xuzhou Central HospitalPhase 3
Changjiang Shipping General 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
Bionpharma NIMODIPINE nimodipine CAPSULE;ORAL 076740-001 Jan 17, 2008 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc NIMODIPINE nimodipine CAPSULE;ORAL 077067-001 Apr 17, 2007 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.