Is there a generic for Ranolazine?

Yes. The FDA Orange Book lists 26 approved generic (ANDA) applications for Ranolazine, referencing the brand ASPRUZYO SPRINKLE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ranolazine?

ASPRUZYO SPRINKLE (NDA 216018, SPIL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ranolazine?

The Orange Book lists 3 patents against Ranolazine products, with the earliest listed expiry in 2038. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ranolazine are approved?

Ranolazine is approved in the following dosage forms: granule, extended release, tablet, extended release.

FDA Orange Book · active-ingredient family

Ranolazine

Ranolazine is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ASPRUZYO SPRINKLE · NDA 216018

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · granule, extended release, tablet, extended release

Product	Applicant	Application	TE	Approved
ASPRUZYO SPRINKLERLD×2	SPIL	NDA 216018	—	Feb 28, 2022
RANEXARLD×2	MENARINI INTL	NDA 021526	—	Feb 12, 2007

Generic (ANDA) products (26)

Product	Applicant	Application	TE	Approved
RANOLAZINE×2	JUBILANT GENERICS	ANDA 211361	AB	Apr 15, 2025
RANOLAZINE×2	TORRENT	ANDA 210407	—	Feb 04, 2025
RANOLAZINE×2	NOVAST LABS	ANDA 210668	AB	Sep 27, 2023
RANOLAZINE×2	PIRAMAL	ANDA 213085	AB	Jul 25, 2023
RANOLAZINE×2	UNICHEM	ANDA 213083	AB	Mar 16, 2023
RANOLAZINE×2	AUROBINDO PHARMA	ANDA 209081	AB	Dec 23, 2022
RANOLAZINE×2	HETERO LABS LTD III	ANDA 212788	AB	May 05, 2022
RANOLAZINE×2	I3 PHARMS	ANDA 213517	AB	Apr 27, 2022
RANOLAZINE×2	VKT PHARMA	ANDA 214035	AB	Jan 19, 2022
RANOLAZINE×2	ACCORD HLTHCARE	ANDA 212930	—	May 18, 2021
RANOLAZINE×2	AMNEAL	ANDA 207690	—	Mar 11, 2021
RANOLAZINE×2	RISING	ANDA 212889	AB	Jan 28, 2021
RANOLAZINE×2	ALKEM LABS LTD	ANDA 209953	AB	Nov 30, 2020
RANOLAZINE×2	ARTHUR GRP	ANDA 212781	AB	Mar 23, 2020
RANOLAZINE×2	SUNSHINE	ANDA 211865	AB	Mar 23, 2020
RANOLAZINE×2	MICRO LABS	ANDA 211745	AB	Feb 27, 2020
RANOLAZINE×2	MANKIND PHARMA	ANDA 212284	AB	Feb 12, 2020
RANOLAZINE×2	ANI PHARMS	ANDA 210482	—	Oct 29, 2019
RANOLAZINE×2	CADILA	ANDA 210188	AB	Aug 19, 2019
RANOLAZINE×2	GLENMARK PHARMS LTD	ANDA 211082	AB	Jul 05, 2019
RANOLAZINE×2	SCIEGEN PHARMS	ANDA 211829	AB	Jun 04, 2019
RANOLAZINE×2	ACTAVIS ELIZABETH	ANDA 208862	AB	May 28, 2019
RANOLAZINE×2	AJANTA PHARMA LTD	ANDA 210054	AB	May 28, 2019
RANOLAZINE×2	CIPLA	ANDA 211291	—	May 28, 2019
RANOLAZINE×2	SUN PHARM	ANDA 211707	—	May 28, 2019
RANOLAZINE×2	CHARTWELL RX	ANDA 201046	AB	Jul 29, 2013

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11510878	Jan 24, 2038	in 11 yr 9 mo	Product
12161761	Jan 24, 2038	in 11 yr 9 mo	Product
10898444	Jan 24, 2038	in 11 yr 9 mo	Product

Ranolazine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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