Is there a generic for Rosuvastatin calcium?

Yes. The FDA Orange Book lists 29 approved generic (ANDA) applications for Rosuvastatin calcium, referencing the brand EZALLOR SPRINKLE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Rosuvastatin calcium?

EZALLOR SPRINKLE (NDA 208647, SUN PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Rosuvastatin calcium?

The Orange Book lists 1 patent against Rosuvastatin calcium products, with the earliest listed expiry in 2036. 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 Rosuvastatin calcium are approved?

Rosuvastatin calcium is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Rosuvastatin calcium

Rosuvastatin calcium is approved as 2 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EZALLOR SPRINKLE · NDA 208647

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, tablet

Product	Applicant	Application	TE	Approved
EZALLOR SPRINKLERLD×4	SUN PHARM	NDA 208647	—	Dec 18, 2018
CRESTORRLD×4	ASTRAZENECA	NDA 021366	AB	Aug 12, 2003

Generic (ANDA) products (29)

Product	Applicant	Application	TE	Approved
ROSUVASTATIN CALCIUM×4	MANKIND PHARMA	ANDA 206603	—	May 16, 2025
ROSUVASTATIN CALCIUM×4	MACLEODS PHARMS LTD	ANDA 207296	—	Nov 06, 2024
ROSUVASTATIN CALCIUM×4	INVENTIA	ANDA 207653	—	Feb 05, 2021
ROSUVASTATIN CALCIUM×4	SUNSHINE	ANDA 210667	—	Apr 01, 2020
ROSUVASTATIN CALCIUM×4	ZHEJIANG YONGTAI	ANDA 212059	AB	Nov 04, 2019
ROSUVASTATIN CALCIUM×4	SHANDONG	ANDA 207375	AB	May 07, 2019
ROSUVASTATIN CALCIUM×4	SCIEGEN PHARMS	ANDA 206381	AB	Apr 24, 2019
ROSUVASTATIN CALCIUM×4	UMEDICA	ANDA 207626	AB	Apr 09, 2019
ROSUVASTATIN CALCIUM×4	ZHEJIANG JINGXIN	ANDA 206513	AB	Mar 01, 2019
ROSUVASTATIN CALCIUM×4	AMNEAL PHARMS CO	ANDA 208850	—	Oct 16, 2018
ROSUVASTATIN CALCIUM×4	MSN	ANDA 208898	AB	Nov 22, 2017
ROSUVASTATIN CALCIUM×4	LUPIN	ANDA 205587	—	Jul 31, 2017
ROSUVASTATIN CALCIUM×4	ALKEM LABS LTD	ANDA 206465	AB	Mar 21, 2017
ROSUVASTATIN CALCIUM×4	CADILA PHARMS LTD	ANDA 207453	AB	Nov 23, 2016
ROSUVASTATIN CALCIUM×4	ACCORD HLTHCARE	ANDA 206434	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	BIOCON PHARMA	ANDA 207752	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	CHANGZHOU PHARM	ANDA 207408	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	HETERO LABS LTD V	ANDA 207616	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	RENATA	ANDA 207062	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	TORRENT	ANDA 201619	AB	Oct 31, 2016
ROSUVASTATIN CALCIUM×4	ANVI	ANDA 079161	—	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	APOTEX	ANDA 079145	—	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	AUROBINDO PHARMA LTD	ANDA 079170	AB	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	CHARTWELL RX	ANDA 079168	AB	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	GLENMARK SPECLT	ANDA 079172	AB	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	SANDOZ	ANDA 079171	—	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	SUN PHARM	ANDA 079169	—	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	TEVA PHARMS USA	ANDA 079166	—	Jul 19, 2016
ROSUVASTATIN CALCIUM×4	WATSON LABS INC	ANDA 079167	AB	Apr 29, 2016

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10413543	Feb 12, 2036	in 9 yr 10 mo	Product

Rosuvastatin calcium — frequently asked questions

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

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