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Last Updated: December 3, 2024

Nimodipine - Generic Drug Details


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What are the generic drug 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, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, Bayer Pharms, Annora Pharma, and Azurity, and is included in eight 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
International Patents:2
US Patents:6
Tradenames:3
Applicants:8
NDAs:8
Drug Master File Entries: 8
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 125
Clinical Trials: 46
Patent Applications: 6,919
Drug Prices: Drug price trends for nimodipine
What excipients (inactive ingredients) are in nimodipine?nimodipine excipients list
DailyMed Link:nimodipine at DailyMed
Drug Prices for nimodipine

See drug prices for nimodipine

Recent Clinical Trials for nimodipine

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

SponsorPhase
Xiaolin Chen, MDPhase 2/Phase 3
Acasti Pharma Inc.Phase 3
Xuzhou Central HospitalPhase 3

See all nimodipine clinical trials

Generic filers with tentative approvals for NIMODIPINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up60MG/10MLSOLUTION;ORAL
⤷  Sign Up⤷  Sign Up30MG/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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-001 May 10, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Pharms NIMOTOP nimodipine CAPSULE;ORAL 018869-001 Dec 28, 1988 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 ⤷  Sign Up ⤷  Sign Up
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 ⤷  Sign Up ⤷  Sign Up
Bayer Pharms NIMOTOP nimodipine CAPSULE;ORAL 018869-001 Dec 28, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nimodipine

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03093108 ⤷  Sign Up
Australia 2003221794 DISPENSER FOR MEDICAMENTS AND METHOD AND APPARATUS FOR MAKING SAME ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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