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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Summary for ROSUVASTATIN CALCIUM
See drug prices for ROSUVASTATIN CALCIUM
Recent Clinical Trials for ROSUVASTATIN CALCIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharma Medica Research, Inc. | Phase 1 |
| NewAmsterdam Pharma | Phase 1 |
| Samsung Medical Center | Phase 4 |
Pharmacology for ROSUVASTATIN CALCIUM
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for ROSUVASTATIN CALCIUM
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shandong | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 207375-004 | May 7, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zhejiang Jingxin | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 206513-001 | Mar 1, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd V | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 207616-001 | Oct 31, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Changzhou Pharm | ROSUVASTATIN CALCIUM | rosuvastatin calcium | TABLET;ORAL | 207408-004 | Oct 31, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
