Nimodipine

For subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless…. Sold as Nimotop, Nymalize. Every FDA application for this active ingredient: 2 branded and 7 generic.

As of Nov 15, 2026, FDA lists 9 applications for Nimodipine (sold as Nimotop, Nymalize), first approved Dec 28, 1988, with 1 new use approved and 0 published complete response letters.

First approved: Dec 28, 1988
Applications: 9
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $808K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Nimodipine	Part D	$756K	-5%	1,214
Nymalize	Part D	$52K	New	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

NIMODIPINE 30 MG CAPSULE: $1.46 per unitGeneric · -4% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of subarachnoid hemorrhage.Arbor Pharmaceuticals, Inc. · designated Sep 16, 2011 · approved May 10, 2013

Clinical Trials

16 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Nimodipine on Alcohol DrinkingAlcohol Use Disorder · Yale University	Phase 2	Not yet recruiting	Jul 2, 2026
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid HemorrhageSubarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage · Beijing Tiantan Hospital	Not applicable	Not yet recruiting	Jun 12, 2026
Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced HypertensionSubarachnoid Aneurysm Hemorrhage, Cerebral Vasospasm After Subarachnoid Hemorrhage · Region Stockholm	—	Recruiting	Dec 26, 2025
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort StudyPost-stroke Pneumonia · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	—	Not yet recruiting	Dec 4, 2025
Cilostazol With Nimodipine to Improve Outcome After Aneurysmal Subarachnoid HemorrhageAneurysmal Subarachnoid Hemorrhage · Centre Hospitalier St Anne	Phase 3	Not yet recruiting	Aug 28, 2025
Nimodipine Variability in SAHSubarachnoid Aneurysm Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal · University of Alberta	—	Recruiting	Jul 15, 2025
Perioperative Intravenous Nimodipine TrialColectomy, Open Surgery · University of Ioannina	Not applicable	Recruiting	Jul 2, 2025
NICardipine for Fast Achievement of Systolic BP Targets in ICHIntracerebral Haemorrhage · Aarhus University Hospital	Phase 4	Recruiting	Jun 29, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 28, 1988	NimotopNDA 18869 · New molecular entity	Bayer Pharms	12	Discontinued
Apr 17, 2007	NimodipineANDA 77067	Sun Pharm Inds Inc	2	Discontinued
May 2, 2007	NimodipineANDA 77811	Heritage	1	Marketed
Jan 17, 2008	NimodipineANDA 76740	Bionpharma	1	Marketed
May 10, 2013	NymalizeNDA 203340 · New dosage form	Azurity	7	Marketed
Apr 7, 2014	NimodipineANDA 90103	Thepharmanetwork LLC	0	Marketed
Jul 24, 2015	NimodipineANDA 201832	Sofgen Pharms	0	Discontinued
Jul 9, 2024	NimodipineANDA 216937	Annora Pharma	0	Marketed
Jan 22, 2025	NimodipineANDA 213409	Alkem Labs Ltd	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA