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NIMOTOP

NDA

NIMODIPINE | N018869 | BAYER PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0267 · 5 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Nimotope (nimodipine) Capsules, 30 mg (NDA 018869), manufactured by Bayer Pharmaceuticals, was withdrawn or discontinued from marketing for safety or effectiveness reasons pu	505(q)	2011-04-14	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

23 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
High Dose Nimodipine Treatment Adjunct - 1 NCT00000332	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	1998-05 → 2000-04
Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy NCT04309708	N/A	Completed	B. Braun Medical International Trading Company Ltd.	300	2018-05-01 → 2019-09-08
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia NCT00004399	N/A	Completed	FDA Office of Orphan Products Development	2,000	1995-09 → 2000-08
Cognitive Effects of Nimodipine in Patients With Schizophrenia NCT03671525	Early Phase 1	Completed	Johns Hopkins University	18	2018-10-05 → 2023-05-12
Glutaminergic Agents for Cocaine Abuse - 5 NCT00000280	Phase 1	Completed	Yale University	—	1994-09 → 1999-08
Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations NCT01835665	Phase 1	Completed	University of California, San Francisco	8	2013-03 → 2016-05
Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning NCT03925025	Phase 3	Completed	University of Edinburgh	1,728	2020-06-11 → 2025-04-30
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life NCT00814658	Phase 4	Completed	Janssen-Cilag Farmaceutica Ltda.	22	2008-06 → 2009-10
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT NCT01672801	N/A	Completed	Boston IVF	18	2012-09 → 2014-04
Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage NCT01893190	Phase 1/2	Completed	Edge Therapeutics Inc	73	2013-09 → 2016-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

LUSOCHIMICA SPANIMODIPINE

DMF 149792000

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)NIMODIPINE (MICRONIZED)

DMF 169512003

DASAMI LAB PRIVATE LTDNIMODIPINE

DMF 329712018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNIMODIPINE

DMF 342032019

LAKSH FINE CHEM PRIVATE LTDNIMODIPINE EP/BP/USP

DMF 436022026

BAYER HEALTHCARE AGInactiveNIMODIPINE

DMF 46641982

BAYER CORPInactiveNIMODIPINE CAPS 10MG (bay e 9736)

DMF 48161982

CATALENT PHARMA SOLUTIONS LLCInactiveNIMODIPINE 30MG SOFTGEL CAPSULES

DMF 155982001

USV LTDInactiveNIMODIPINE USP

DMF 178492004

CATALENT PHARMA SOLUTIONS LLCInactiveNIMODIPINE 30MG SOFTGELS

DMF 183732005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 30, 2006	SUPPL -14	View Letter (PDF)
Aug 22, 2000	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 28, 1988

No patent or exclusivity listings for this strength.