ROSUVASTATIN CALCIUM - Generic Drug Details

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What are the generic drug sources for rosuvastatin calcium and what is the scope of freedom to operate?

Rosuvastatin calcium is the generic ingredient in three branded drugs marketed by Sun Pharm, IPR, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd V, Inventia, Lupin, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in twenty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rosuvastatin calcium has two patent family members in two countries.

There are forty drug master file entries for rosuvastatin calcium. Forty-four suppliers are listed for this compound.

Summary for ROSUVASTATIN CALCIUM

International Patents:	2
US Patents:	1
Tradenames:	3
Applicants:	28
NDAs:	29
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	33
Patent Applications:	6,807
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ROSUVASTATIN CALCIUM
Drug Sales Revenues:	Drug sales revenues for ROSUVASTATIN CALCIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROSUVASTATIN CALCIUM
What excipients (inactive ingredients) are in ROSUVASTATIN CALCIUM?	ROSUVASTATIN CALCIUM excipients list
DailyMed Link:	ROSUVASTATIN CALCIUM at DailyMed

See drug prices for ROSUVASTATIN CALCIUM

Drug Sales Revenue Trends for ROSUVASTATIN CALCIUM

See drug sales revenues for ROSUVASTATIN CALCIUM

Recent Clinical Trials for ROSUVASTATIN CALCIUM

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

Sponsor	Phase
NewAmsterdam Pharma	Phase 1
Pharma Medica Research, Inc.	Phase 1
Samsung Medical Center	Phase 4

See all ROSUVASTATIN CALCIUM clinical trials

Pharmacology for ROSUVASTATIN CALCIUM

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

Medical Subject Heading (MeSH) Categories for ROSUVASTATIN CALCIUM

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ROSUVASTATIN CALCIUM

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

Paragraph IV (Patent) Challenges for ROSUVASTATIN CALCIUM

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 ROSUVASTATIN CALCIUM

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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
Hetero Labs Ltd V	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	207616-004	Oct 31, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-002	Dec 18, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Cadila Pharms Ltd	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	207453-001	Nov 23, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	206381-003	Apr 24, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocon Pharma	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	207752-004	Oct 31, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079167-003	Apr 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	205587-004	Jul 31, 2017	AB	RX	No	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 ROSUVASTATIN CALCIUM

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

International Patents for ROSUVASTATIN CALCIUM

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3344242		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2017037740		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ROSUVASTATIN CALCIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	CR 2014 00048	Denmark	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: ROSUVASTATIN
0521471	C300125	Netherlands	⤷ Sign Up	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	03C0043	France	⤷ Sign Up	PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0720599	C300688	Netherlands	⤷ Sign Up	PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0720599	300688	Netherlands	⤷ Sign Up	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	SPC/GB03/033	United Kingdom	⤷ Sign Up	PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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