CRESTOR Drug Patent Profile

When do Crestor patents expire, and what generic alternatives are available?

Crestor is a drug marketed by IPR and is included in one NDA.

The generic ingredient in CRESTOR is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crestor

A generic version of CRESTOR was approved as rosuvastatin calcium by WATSON LABS INC on April 29^th, 2016.

Summary for CRESTOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	177
Patent Applications:	1,716
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CRESTOR
Drug Sales Revenues:	Drug sales revenues for CRESTOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CRESTOR
What excipients (inactive ingredients) are in CRESTOR?	CRESTOR excipients list
DailyMed Link:	CRESTOR at DailyMed

See drug prices for CRESTOR

See drug sales revenues for CRESTOR

Recent Clinical Trials for CRESTOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
University of Karachi	N/A
The Searle Company Limited	N/A

See all CRESTOR clinical trials

Pharmacology for CRESTOR

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CRESTOR

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for CRESTOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESTOR	Tablets	rosuvastatin calcium	5 mg, 10 mg, 20 mg and 40 mg	021366	9	2007-08-13

US Patents and Regulatory Information for CRESTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	AB	RX	Yes	No
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	AB	RX	Yes	Yes
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	AB	RX	Yes	No
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	AB	RX	Yes	No

Expired US Patents for CRESTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003

International Patents for CRESTOR

See the table below for patents covering CRESTOR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2018853
Hungary	222578	Pirimidin-5-il-hepténsav-származékot és tribázikus foszfátsót tartalmazó gyógyászati készítmények és eljárás előállításukra (PHARMACEUTICAL COMPOSITIONS CONTAINING PYRIMIDIN-5-YL-HEPTENOIC ACID DERIVATIVE AND TRIBASIC PHOSPHATE SALT AND PROCESS FOR PRODUCING THEM)
Denmark	1223918
China	1319396
China	101028268
Mexico	PA03004336	USO DE ROSUVASTATIN (ZD-4522) EN EL TRATAMIENTO DE HIPERCOLESTEROLEMIA FAMILAR HETEROCIGOTICA. (USE OF ROSUVASTATIN (ZD-4522) IN THE TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA.)

Supplementary Protection Certificates for CRESTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0720599	300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0521471	0390023-0	Sweden		PRODUCT NAME: ROSUVASTATIN
0720599	CR 2014 00048	Denmark		PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN
0521471	CA 2003 00024	Denmark