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Last Updated: March 28, 2024

ROSUVASTATIN CALCIUM Drug Patent Profile


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Which patents cover Rosuvastatin Calcium, and what generic alternatives are available?

Rosuvastatin Calcium is a drug marketed by 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, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai. and is included in twenty-seven NDAs.

The generic ingredient in ROSUVASTATIN CALCIUM is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rosuvastatin Calcium

A generic version of ROSUVASTATIN CALCIUM was approved as rosuvastatin calcium by WATSON LABS INC on April 29th, 2016.

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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
Shandong ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207375-004 May 7, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zhejiang Jingxin ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206513-001 Mar 1, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207616-001 Oct 31, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Changzhou Pharm ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207408-004 Oct 31, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079166-002 Jul 19, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 205587-001 Jul 31, 2017 AB RX 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

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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.