Crestor Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Crestor, and what generic alternatives are available?
Crestor is a drug marketed by IPR and is included in one NDA.
The generic ingredient in CRESTOR 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 Crestor
A generic version of Crestor was approved as rosuvastatin calcium by WATSON LABS INC on April 29th, 2016.
Summary for Crestor
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 177 |
Patent Applications: | 1,716 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Crestor |
Drug Sales Revenues: | Drug sales revenues for Crestor |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Crestor |
What excipients (inactive ingredients) are in Crestor? | Crestor excipients list |
DailyMed Link: | Crestor at DailyMed |
Recent Clinical Trials for Crestor
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Wake Forest University Health Sciences | Phase 4 |
The Searle Company Limited | N/A |
University of Karachi | N/A |
Pharmacology for Crestor
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Crestor
Paragraph IV (Patent) Challenges for CRESTOR
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 Crestor
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-002 | Aug 12, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-005 | Aug 12, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-003 | Aug 12, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-004 | Aug 12, 2003 | AB | RX | Yes | 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 Crestor
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-003 | Aug 12, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-003 | 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 | 021366-004 | Aug 12, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Crestor
See the table below for patents covering Crestor around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20000072135 | ⤷ Try a Trial | |
Slovakia | 11782000 | FARMACEUTICKÁ KOMPOZÍCIA (PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
Portugal | 1003501 | ⤷ Try a Trial | |
Australia | 782386 | ⤷ Try a Trial | |
Israel | 150513 | ⤷ Try a Trial | |
Montenegro | 00202 | FARMACEUTSKE SMJEŠE KOJE OBUHVATAJU INHIBITOR HMG COA REDUKTAZE (PHARMACEUTICAL COMPOSITIONS COMPRISING A HMG COA REDUCTASE INHIBITOR) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Crestor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0521471 | 03C0043 | France | ⤷ Try a Trial | PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106 |
0521471 | C00521471/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH |
0720599 | 300688 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 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 |
0521471 | 0391023-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ROSUVASTATIN |
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 |