Ranolazine

Treats chronic angina. Sold as Ranexa, Aspruzyo Sprinkle. Every FDA application for this active ingredient: 2 branded and 28 generic.

As of Nov 14, 2026, FDA lists 30 applications for Ranolazine (sold as Ranexa, Aspruzyo Sprinkle), first approved Jan 27, 2006, with 1 new use approved and 0 published complete response letters.

First approved: Jan 27, 2006
Applications: 30
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $106M
First approved in the EU: Jul 8, 2008

Medicare Spending

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


Ranolazine ER	Part D	$106M	-5%	321,164
Aspruzyo Sprinkle	Part D	$0K	-100%	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

RANOLAZINE ER 1,000 MG TABLET: $0.275 per unitGeneric · -3% in a year
RANOLAZINE ER 500 MG TABLET: $0.166 per unitGeneric · +1% in a year

Approvals in the EU (EMA)

First approved in the EU 29 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ranexa (previously Latixa), new substanceMenarini International Operations Luxembourg S.A. (MIOL) · Jul 8, 2008

Clinical Trials

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


Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON StudySTEMI (ST Elevation MI) · Federico II University	Phase 2 / Phase 3	Recruiting	Feb 2, 2026
Feasibility Trial for a Right Ventricular Failure Platform TrialPulmonary Hypertension, Right Ventricular Dysfunction · University of Alberta	Phase 2	Recruiting	Aug 26, 2024
A Study of Ranolazine in ALSAmyotrophic Lateral Sclerosis · Swathy Chandrashekhar, MBBS	Phase 2	Recruiting	Jul 30, 2024
COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular AnginaCoronary Microvascular Disease, Refractory Angina · Johannes Gutenberg University Mainz	Not applicable	Recruiting	Oct 28, 2020

Applications

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


Jan 27, 2006	RanexaNDA 21526 · New molecular entity	Menarini Intl	16	Discontinued
Jul 29, 2013	RanolazineANDA 201046	Chartwell Rx	5	Marketed
May 28, 2019	RanolazineANDA 208862	Actavis Elizabeth	1	Discontinued
May 28, 2019	RanolazineANDA 210054	Ajanta Pharma Ltd	2	Marketed
May 28, 2019	RanolazineANDA 211291	Cipla	2	Discontinued
May 28, 2019	RanolazineANDA 211707	Sun Pharm	2	Discontinued
Jun 4, 2019	RanolazineANDA 211829	Sciegen Pharms	2	Marketed
Jul 5, 2019	RanolazineANDA 211082	Glenmark Pharms Ltd	2	Marketed
Aug 19, 2019	RanolazineANDA 210188	Cadila	1	Marketed
Oct 29, 2019	RanolazineANDA 210482	Ani Pharms	1	Discontinued
Feb 12, 2020	RanolazineANDA 212284	Mankind Pharma	0	Marketed
Feb 27, 2020	RanolazineANDA 211745	Micro Labs	0	Discontinued
Mar 23, 2020	RanolazineANDA 211865	Sunshine	0	Marketed
Mar 23, 2020	RanolazineANDA 212781	Quagen	0	Marketed
Nov 30, 2020	RanolazineANDA 209953	Alkem Labs Ltd	0	Marketed
Jan 28, 2021	RanolazineANDA 212889	Rising	1	Marketed
Mar 11, 2021	RanolazineANDA 207690	Amneal	0	Discontinued
May 18, 2021	RanolazineANDA 212930	Accord Hlthcare	0	Discontinued
Jan 19, 2022	RanolazineANDA 214035	Vkt Pharma	1	Marketed
Feb 28, 2022	Aspruzyo SprinkleNDA 216018 · New dosage form	Spil	0	Discontinued
Apr 27, 2022	RanolazineANDA 213517	Pharmazone	0	Marketed
May 5, 2022	RanolazineANDA 212788	Hetero Labs Ltd Iii	0	Marketed
Dec 23, 2022	RanolazineANDA 209081	Aurobindo Pharma	0	Marketed
Mar 16, 2023	RanolazineANDA 213083	Unichem	0	Marketed
Jul 25, 2023	RanolazineANDA 213085	Piramal	0	Marketed
Sep 27, 2023	RanolazineANDA 210668	Novast Labs	0	Marketed
Feb 4, 2025	RanolazineANDA 210407	Torrent	0	Discontinued
Apr 15, 2025	RanolazineANDA 211361	Jubilant Generics	0	Marketed
Aug 5, 2026	RanolazineANDA 214551	Umedica	0	Marketed
—	RanolazineANDA 208174	Teva Pharms	0	Discontinued

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