CRESTOR Drug Patent Profile
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Which patents cover Crestor, 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for CRESTOR?
- What are the global sales for CRESTOR?
- What is Average Wholesale Price for CRESTOR?
Summary for CRESTOR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 178 |
Patent Applications: | 1,466 |
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 |
![CRESTOR drug patent expirations Drug patent expirations by year for CRESTOR](/p/graph/s/t/CRESTOR-patent-expirations.png)
![Drug Prices for CRESTOR](/p/graph/drug-price/CRESTOR.png)
![Drug Sales Revenue Trends for CRESTOR](/p/graph/drug-sales-revenues/CRESTOR.png)
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-005 | Aug 12, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-003 | Aug 12, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-004 | Aug 12, 2003 | AB | RX | Yes | 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 |
Expired US Patents for CRESTOR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-002 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-005 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-005 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-004 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-002 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-004 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-005 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Israel | 150513 | ⤷ Sign Up | |
Poland | 348775 | ⤷ Sign Up | |
Germany | 60001371 | ⤷ Sign Up | |
Japan | 4800988 | ⤷ Sign Up | |
European Patent Office | 1520590 | ⤷ Sign Up | |
South Africa | 200003997 | Pharmaceutical compositions. | ⤷ Sign Up |
Netherlands | 1015859 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CRESTOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0521471 | 91042 | Luxembourg | ⤷ Sign Up | 91042, EXPIRES: 20170630 |
0720599 | CR 2014 00048 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724 |
0521471 | 03C0043 | France | ⤷ Sign Up | PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106 |
0720599 | 92544 | Luxembourg | ⤷ Sign Up | 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 | CA 2003 00024 | Denmark | ⤷ Sign Up | |
0720599 | 300688 | Netherlands | ⤷ Sign Up | 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 | SPC/GB03/033 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |