crestor Drug Patent Profile

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When do Crestor patents expire, 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-nine 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:	178
Patent Applications:	1,466
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

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-005	Aug 12, 2003	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	021366-004	Aug 12, 2003	⤷ Sign Up	⤷ Sign Up
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-004	Aug 12, 2003	⤷ Sign Up	⤷ Sign Up
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-003	Aug 12, 2003	⤷ Sign Up	⤷ Sign Up
>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
Czech Republic	301583	Lécivo obsahující rosuvastatin pro lécení heterozygótní familiární hypercholesterolémie (Medicament containing rosuvastatin intended for treating heterozygous familial hypercholesterolemia)	⤷ Sign Up
India	213326		⤷ Sign Up
Bulgaria	106393		⤷ Sign Up
>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	91042	Luxembourg	⤷ Sign Up	91042, EXPIRES: 20170630
0720599	92544	Luxembourg	⤷ Sign Up	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	C00521471/01	Switzerland	⤷ Sign Up	FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description