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Last Updated: December 1, 2021

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Rosuvastatin calcium - Generic Drug Details

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What are the generic drug sources for rosuvastatin calcium and what is the scope of patent protection?

Rosuvastatin calcium is the generic ingredient in three branded drugs marketed by Sun Pharma Global, IPR, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd V, Inventia, Lupin, MSN, Mylan, Renata, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Zhejiang Yongtai, and Zydus Pharms, and is included in twenty-nine NDAs. There are three 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 two patent family members in forty-nine countries.

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

Drug Prices for rosuvastatin calcium

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Drug Sales Revenue Trends for rosuvastatin calcium

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Recent Clinical Trials for rosuvastatin calcium

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SponsorPhase
EMSPhase 3
Chinese University of Hong KongN/A
Ottawa Hospital Research InstitutePhase 3

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Pharmacology for rosuvastatin calcium
Medical Subject Heading (MeSH) Categories for rosuvastatin calcium
Paragraph IV (Patent) Challenges for ROSUVASTATIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
CRESTOR TABLET;ORAL rosuvastatin calcium 021366 2007-08-13

US Patents and Regulatory Information 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
Msn ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208898-003 Nov 22, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079170-004 Jul 19, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Inventia ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207653-003 Feb 5, 2021 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ⤷  Try it Free ⤷  Try it Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try it Free ⤷  Try it Free
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for rosuvastatin calcium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0521471 SPC/GB03/033 United Kingdom ⤷  Try it Free 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
0521471 0391023-9 Sweden ⤷  Try it Free PRODUCT NAME: ROSUVASTATIN
0521471 03C0043 France ⤷  Try it Free PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.