crestor Drug Patent Profile
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When do Crestor patents expire, and when can generic versions of Crestor launch?
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 |
University of Karachi | N/A |
The Searle Company Limited | 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 | 021366-004 | 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 |
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 |
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 |
>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 |
---|---|---|---|
New Zealand | 512560 | ⤷ Try a Trial | |
Taiwan | I238720 | ⤷ Try a Trial | |
Iceland | 2805 | ⤷ Try a Trial | |
Japan | 5062940 | ⤷ Try a Trial | |
Montenegro | 00191 | FARMACEUTSKE KOMPOZICIJE KOJE OBUHVATAJU INHIBITOR HMG REDUKTAZE (PHARMACEUTICAL COMPOSITIONS COMPRISING A HMG COA REDUCTASE INHIBITOR) | ⤷ Try a Trial |
Canada | 2639407 | COMPOSITIONS PHARMACEUTIQUES COMPORTANT DE L'ACIDE (E)-7-[4-(4-FLUOROPHENYL)-6-ISOPROPYL-2-[METHYL(METHYLSULFONYL)AMINO]- PYRIMIDIN-5-YL]-(3R, 5S)-DIHYDROXYHEPT-6-ENOIQUE OU UN SEL ACCEPTABLE DE CELUI-CI (PHARMACEUTICAL COMPOSITIONS COMPRISING (E)-7-[4-(4-FLUOROPHENYL)-6-ISOPROPYL-2-[METHYL(METHYLSULFONYL)AMINO]PYRIMIDIN-5-YL]-(3R,5S)-3,5-DIHYDROXYHEPT-6-ENOIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF) | ⤷ Try a Trial |
Czech Republic | 299105 | Farmaceutická kompozice a použití povlaku obsahujícího oxid železitý (Pharmaceutical composition and use of ferric oxide light protective coating) | ⤷ 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 | 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 | 91042 | Luxembourg | ⤷ Try a Trial | 91042, EXPIRES: 20170630 |
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 |
0521471 | 0391023-9 | 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 | 03C0043 | France | ⤷ Try a Trial | PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |