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Last Updated: August 13, 2020

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ROSUVASTATIN CALCIUM Drug 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, Allied, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, MSN, Mylan, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Zhejiang Yongtai, and Zydus Pharms. and is included in twenty-six NDAs.

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

US ANDA 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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Drug patent expirations by year for ROSUVASTATIN CALCIUM
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
Assiut UniversityPhase 2
Ottawa Hospital Research InstitutePhase 3
Chinese University of Hong KongN/A

See all ROSUVASTATIN CALCIUM clinical trials

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
Shandong ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207375-004 May 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206513-001 Mar 1, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207616-001 Oct 31, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207453-004 Nov 23, 2016 AB RX 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

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