CRESTOR Drug Patent Profile

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Which patents cover Crestor, and when can generic versions of Crestor launch?

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-three 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.

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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

Drug patent expirations by year for CRESTOR

Recent Clinical Trials for CRESTOR

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

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

CRESTOR is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting CRESTOR

AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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

Expired US Patents for CRESTOR

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

International Patents for CRESTOR

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

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Country	Patent Number	Title	Estimated Expiration
South Africa	200303636	Use of rosuvastatin (ZD-4522) in the treatment of heterozygous familial hypercholesterolemia.	⤷ Try a Trial
Greece	3035189		⤷ Try a Trial
South Korea	100388713		⤷ Try a Trial
Argentina	025055	COMPOSICIONES FARMACEUTICAS	⤷ Try a Trial
Georgia, Republic of	P20022693	Pyrimidine Derivatives as HMG-Coa Reductase Inhibitors	⤷ Try a Trial
Spain	2153824		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CRESTOR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	300125	Netherlands	⤷ Try a Trial
0521471	C00521471/01	Switzerland	⤷ Try a Trial	FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0720599	92544	Luxembourg	⤷ Try a Trial	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
0521471	03C0043	France	⤷ Try a Trial	PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0521471	C300125	Netherlands	⤷ Try a Trial	PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0521471	CA 2003 00024	Denmark	⤷ Try a Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description