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Rosuvastatin calcium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for rosuvastatin calcium?

Rosuvastatin calcium is the generic ingredient in two branded drugs marketed by Changzhou Pharm, Hetero Labs Ltd V, Torrent Pharms Llc, Accord Hlthcare Inc, Apotex Inc, Biocon Ltd, Cadila Pharms Ltd, Mylan Pharms Inc, Jubilant Generics, IPR, Teva Pharms Usa, Watson Labs Inc, Par Pharm Inc, Sun Pharma Global, Aurobindo Pharma Ltd, Sandoz Inc, and Glenmark Pharms, and is included in seventeen NDAs. There are six 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 fifteen patent family members in fifty-two countries.

There are thirty-seven drug master file entries for rosuvastatin calcium. Thirty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: rosuvastatin calcium

Tradenames:2
Patents:6
Applicants:17
NDAs:17
Drug Master File Entries: see list37
Suppliers / Packagers: see list38
Bulk Api Vendors: see list67
Clinical Trials: see list904
Patent Applications: see list242
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rosuvastatin calcium at DailyMed

Pharmacology for Ingredient: rosuvastatin calcium

Tentative approvals for ROSUVASTATIN CALCIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL5MG
► Subscribe► SubscribeTABLET;ORAL5MG
► Subscribe► SubscribeTABLET;ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL079169-001Jul 19, 2016RXNoNo► Subscribe► Subscribe
Biocon Ltd
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL207752-004Oct 31, 2016RXNoNo► Subscribe► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYesYes► Subscribe► Subscribe
Accord Hlthcare Inc
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL206434-001Oct 31, 2016RXNoNo► Subscribe► Subscribe
Sandoz Inc
ROSUVASTATIN CALCIUM
rosuvastatin calcium
TABLET;ORAL079171-004Jul 19, 2016RXNoNo► Subscribe► 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;ORAL021366-005Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-004Aug 12, 2003RE37314*PED► Subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RE37314*PED► 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
Bulgaria66009► Subscribe
Australia6580000► Subscribe
New Zealand531474► Subscribe
Belgium1013413► Subscribe
Switzerland691347► 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
90023-0Sweden► SubscribePRODUCT NAME: ROSUVASTATIN
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
042Luxembourg► Subscribe91042, EXPIRES: 20170630
2003 00024Denmark► Subscribe
C0043France► SubscribePRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
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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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