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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Nimodipine on Alcohol Drinking NCT07681869	Phase 2	Not Yet Recruiting	Yale University	40	2026-09-01 → 2032-06-30
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage NCT07643922	N/A	Recruiting	Beijing Tiantan Hospital	306	2026-06-03 → 2029-12-31

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

API Supply Chain4 active DMFs5 inactive

4 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

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#001 — 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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