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-nine 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.
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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 |
| 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 |
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 | 021366-004 | 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 | 021366-003 | 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 | 021366-005 | Aug 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Ipr | CRESTOR | rosuvastatin calcium | TABLET;ORAL | 021366-002 | 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 |
|---|---|---|---|
| Czech Republic | 301583 | Lécivo obsahující rosuvastatin pro lécení heterozygótní familiární hypercholesterolémie (Medicament containing rosuvastatin intended for treating heterozygous familial hypercholesterolemia) | ⤷ Sign Up |
| India | 213326 | ⤷ Sign Up | |
| Bulgaria | 106393 | ⤷ Sign Up | |
| Taiwan | 553749 | ⤷ Sign Up | |
| Norway | 20003968 | ⤷ Sign Up | |
| Bulgaria | 110353 | ⤷ 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 | 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 | C00521471/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH |
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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