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Rosuvastatin calcium - Generic Drug Details

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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, 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 sixteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fifteen patent family members in fifty-two countries.

There are thirty-four 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:5
Applicants:16
NDAs:16
Drug Master File Entries: see list34
Suppliers / Packaging: see list38
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: rosuvastatin calcium

Tentative approvals for ROSUVASTATIN CALCIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL5MG
<disabled><disabled>TABLET;ORAL5MG
<disabled><disabled>TABLET;ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 12, 2003RXYes6,316,460*PED► subscribeY► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RXNo7,030,152*PED► subscribeY► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RXNo7,030,152*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: rosuvastatin calcium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-003Aug 12, 2003RE37314*PED► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-002Aug 12, 2003RE37314*PED► subscribe
Ipr
CRESTOR
rosuvastatin calcium
TABLET;ORAL021366-005Aug 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
South Korea100388713► subscribe
Portugal521471► subscribe
Germany60133921► 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
91023-9Sweden► subscribePRODUCT NAME: ROSUVASTATIN
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
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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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