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Last Updated: December 5, 2020

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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, Allied, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, 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-eight 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. There is one tentative approval 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

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

SponsorPhase
EMSPhase 3
Assiut UniversityPhase 2
Ottawa Hospital Research InstitutePhase 3

See all rosuvastatin calcium clinical trials

Generic filers with tentative approvals for ROSUVASTATIN CALCIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialUNKNOWNUNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Accord Hlthcare ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206434-003 Oct 31, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206434-001 Oct 31, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 205587-001 Jul 31, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079169-003 Jul 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Shandong ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207375-004 May 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079166-001 Jul 19, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
>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 021366-005 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   Start Trial   Start Trial
>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   Start Trial 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
0720599 92544 Luxembourg   Start Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0521471 03C0043 France   Start Trial PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0720599 CR 2014 00048 Denmark   Start Trial 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 0390023-0 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
0521471 0391023-9 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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