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Last Updated: March 18, 2024

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 Pharm, IPR, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd V, Inventia, Lupin, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in twenty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rosuvastatin calcium has two patent family members in two countries.

There are forty drug master file entries for rosuvastatin calcium. Forty-four 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
Samsung Medical CenterPhase 4
Turning Point Therapeutics, Inc.Phase 1
EMSPhase 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 Strength NDA ANDAs Submitted Submissiondate
CRESTOR Tablets rosuvastatin calcium 5 mg, 10 mg, 20 mg and 40 mg 021366 9 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
Inventia ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207653-004 Feb 5, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850-001 Oct 16, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079167-003 Apr 29, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Inventia ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207653-002 Feb 5, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079145-002 Jul 19, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021366-003 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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
0521471 0390023-0 Sweden ⤷  Try a Trial PRODUCT NAME: ROSUVASTATIN
0720599 92544 Luxembourg ⤷  Try a 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 C300125 Netherlands ⤷  Try a Trial PRODUCT 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
0720599 C300688 Netherlands ⤷  Try a Trial PRODUCT 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
>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.