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RANEXA

NDA

RANOLAZINE | N021526 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Premier Research FDA-2025-P-3313 Premier Research filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Ranolazine Extended-release Tablets (750 mg) is suitable for submission in a supplemental Abbreviated New Drug Application (sANDA). The	Suitability	2025-08-22	Open	Premier Research

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ranexa (2023)

Total Spending

$1.9M

Total Claims

2,469

Beneficiaries

1,203

Avg Cost/Unit

$8.58

Spending Trend

$246.6M(2019)→$20.1M(2020)→$10.8M(2021)→$8.1M(2022)→$1.9M(2023)

YoY Change:+2.7%

5yr CAGR:+4.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain23 active DMFs5 inactive

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

AARTI PHARMALABS LTDRANOLAZINE

DMF 218662008

COSMA SPARANOLAZINE

DMF 228112009

PH HEALTH LTDRANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 234012009

DR REDDYS LABORATORIES LTDRANOLAZINE

DMF 236212010

MSN PHARMACHEM PRIVATE LTDRANOLAZINE [ROUTE CODE - "RL"]

DMF 248982011

UNICHEM LABORATORIES LTDRANOLAZINE

DMF 274942013

APITORIA PHARMA PRIVATE LTDRANOLAZINE

DMF 294832015

ZYDUS LIFESCIENCES LTDRANOLAZINE (PROCESS II)

DMF 297362016

JUBILANT PHARMOVA LTDRANOLAZINE

DMF 311602016

RAKS PHARMA PVT LTDRANOLAZINE

DMF 311822016

SUN PHARMACEUTICAL INDUSTRIES LTDRANOLAZINE

DMF 315362017

UNION QUIMICO FARMACEUTICA SA (UQUIFA)RANOLAZINE

DMF 319402017

CHEMO SMS ENTERPRISE SLRANOLAZINE

DMF 321332017

DASAMI LAB PRIVATE LTDRANOLAZINE

DMF 325392018

ALIVUS LIFE SCIENCES LTDRANOLAZINE

DMF 325732018

AMOLI ORGANICS PRIVATE LTDRANOLAZINE

DMF 330012018

ALMELO PVT LTDRANOLAZINE

DMF 330302018

MSN LIFE SCIENCES PRIVATE LTDRANOLAZINE

DMF 333072018

MANKIND PHARMA LTDRANOLAZINE

DMF 345712020

INNOVARE LABS PRIVATE LTDRANOLAZINE

DMF 364042022

METROCHEM API PRIVATE LTDRANOLAZINE

DMF 373392022

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDRANOLAZINE

DMF 374532022

AJANTA PHARMA LTDRANOLAZINE

DMF 379932023

CIPLA LTDInactiveRANOLAZINE

DMF 219662008

MSN PHARMACHEM PRIVATE LTDInactiveRANOLAZINE [ROUTE CODE - "RA"]

DMF 223502008

LUPIN LTDInactiveRANOLAZINE

DMF 232452009

CADILA HEALTHCARE LTDInactiveRANOLAZINE

DMF 234322010

APOTEX PHARMACHEM INDIA PVT LTDInactiveRANOLAZINE

DMF 307122016

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Oct 30, 2019	SUPPL -35	View Letter (PDF)
Aug 13, 2019	SUPPL -34	View Letter (PDF)
Jan 7, 2016	SUPPL -29	View Letter (PDF)
Dec 16, 2015	SUPPL -28	View Letter (PDF)
Dec 20, 2013	SUPPL -26	View Letter (PDF)
Nov 15, 2013	SUPPL -25	View Letter (PDF)
Jul 30, 2012	SUPPL -22	View Letter (PDF)
Dec 28, 2011	SUPPL -18	View Letter (PDF)
Jul 13, 2011	SUPPL -14	View Letter (PDF)
Sep 28, 2010	SUPPL -12	View Letter (PDF)
Mar 27, 2009	SUPPL -7	View Letter (PDF)
Nov 6, 2008	SUPPL -4	View Letter (PDF)
Jan 9, 2008	SUPPL -2	View Letter (PDF)
Feb 8, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 12, 2007

No patent or exclusivity listings for this strength.

#002 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 27, 2006