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Serving leading biopharmaceutical companies globally:

Citi
Harvard Business School
Mallinckrodt
US Army
Chubb
Chinese Patent Office
Fish and Richardson
Merck
Teva
Colorcon

Generated: November 22, 2017

DrugPatentWatch Database Preview

Rosuvastatin calcium - Generic Drug Details

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

Rosuvastatin calcium
is the generic ingredient in two branded drugs marketed by Changzhou Pharm, Hetero Labs Ltd V, Torrent Pharms Ltd, Accord Hlthcare, Apotex Inc, Biocon Ltd, Cadila Pharms Ltd, Mylan Pharms Inc, Jubilant Generics, Alkem Labs Ltd, IPR, Teva Pharms Usa, Watson Labs Inc, Par Pharm Inc, Sun Pharma Global, Aurobindo Pharma Ltd, Sandoz Inc, Glenmark Pharms, and Lupin Ltd, and is included in nineteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rosuvastatin calcium has two hundred and twenty patent family members in fifty-two countries and twelve supplementary protection certificates in seven countries.

There are thirty-nine drug master file entries for rosuvastatin calcium. Forty-three suppliers are listed for this compound.

Pharmacology for rosuvastatin calcium

Medical Subject Heading (MeSH) Categories for rosuvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL201619-002Oct 31, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL079167-004Apr 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Sandoz Inc
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL079171-002Jul 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL201619-001Oct 31, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003ABRXYesYes► Subscribe► SubscribeY► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: rosuvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: rosuvastatin calcium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,548,513 Pharmaceutical compositions► Subscribe
5,260,440 Pyrimidine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: rosuvastatin calcium

Country Document Number Estimated Expiration
Japan3267960► Subscribe
Poland341855► Subscribe
Germany69231530► Subscribe
World Intellectual Property Organization (WIPO)0154669► Subscribe
Slovakia6212003► Subscribe
Ukraine75614► Subscribe
Bulgaria107811► Subscribe
Denmark1339409► Subscribe
AustriaA13612000► Subscribe
Malaysia134902► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ROSUVASTATIN CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0043France► SubscribePRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
00125Netherlands► SubscribePRODUCT 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
C/GB03/033United Kingdom► SubscribePRODUCT 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
0521471/01Switzerland► SubscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
2014 00048Denmark► SubscribePRODUCT 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
544Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0125Netherlands► Subscribe
00688Netherlands► SubscribePRODUCT 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
2003 00024Denmark► Subscribe
90023-0Sweden► SubscribePRODUCT NAME: ROSUVASTATIN
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Serving leading biopharmaceutical companies globally:

Novartis
Accenture
Johnson and Johnson
Mallinckrodt
Federal Trade Commission
US Department of Justice
Boehringer Ingelheim
Colorcon
Medtronic
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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