Crestor is a drug owned by Ipr Pharmaceuticals Inc. It is protected by 10 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 27, 2023. Details of Crestor's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6858618 (Pediatric) | Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia |
Jun, 2022
(2 years ago) |
Expired
|
| US6858618 | Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia |
Dec, 2021
(3 years ago) |
Expired
|
|
US6316460 (Pediatric) | Pharmaceutical compositions |
Feb, 2021
(3 years ago) |
Expired
|
| US6316460 | Pharmaceutical compositions |
Aug, 2020
(4 years ago) |
Expired
|
|
US7030152 (Pediatric) | Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease |
Oct, 2018
(6 years ago) |
Expired
|
|
US7964614 (Pediatric) | Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease |
Oct, 2018
(6 years ago) |
Expired
|
| US7030152 | Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease |
Apr, 2018
(6 years ago) |
Expired
|
| US7964614 | Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease |
Apr, 2018
(6 years ago) |
Expired
|
|
USRE37314 (Pediatric) | Pyrimidine derivatives |
Jul, 2016
(8 years ago) |
Expired
|
| USRE37314 | Pyrimidine derivatives |
Jan, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Crestor's patents.
Latest Legal Activities on Crestor's Patents
Given below is the list of recent legal activities going on the following patents of Crestor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 29 Jul, 2019 | US7964614 |
| Maintenance Fee Reminder Mailed Critical | 11 Feb, 2019 | US7964614 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jun, 2011 | US7964614 |
| Recordation of Patent Grant Mailed Critical | 21 Jun, 2011 | US7964614 |
| Issue Notification Mailed Critical | 01 Jun, 2011 | US7964614 |
| Dispatch to FDC | 19 May, 2011 | US7964614 |
| Mail Response to 312 Amendment (PTO-271) Critical | 18 May, 2011 | US7964614 |
| Response to Amendment under Rule 312 Critical | 16 May, 2011 | US7964614 |
| Application Is Considered Ready for Issue Critical | 16 May, 2011 | US7964614 |
| Issue Fee Payment Verified Critical | 22 Apr, 2011 | US7964614 |
FDA has granted several exclusivities to Crestor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Crestor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Crestor.
Exclusivity Information
Crestor holds 8 exclusivities. All of its exclusivities have expired in 2023. Details of Crestor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-573) | Nov 06, 2011 |
| New Indication(I-611) | Oct 16, 2012 |
| New Indication(I-621) | Feb 08, 2013 |
| Pediatric Exclusivity(PED) | Apr 16, 2013 |
| New Patient Population(NPP) | Nov 20, 2018 |
| New Indication(I-732) | May 27, 2019 |
| Orphan Drug Exclusivity(ODE) | May 27, 2023 |
| Orphan Drug Exclusivity(ODE-118) | May 27, 2023 |
US patents provide insights into the exclusivity only within the United States, but Crestor is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Crestor's family patents as well as insights into ongoing legal events on those patents.
Crestor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Crestor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 27, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Crestor Generic API suppliers:
Rosuvastatin Calcium is the generic name for the brand Crestor. 28 different companies have already filed for the generic of Crestor, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Crestor's generic
How can I launch a generic of Crestor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Crestor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Crestor's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Crestor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 20 mg and 40 mg | 13 Aug, 2007 | 9 | 29 Apr, 2016 | 04 Aug, 2020 | Non-Forfeiture |
Alternative Brands for Crestor
Crestor which is used for treating high cholesterol and preventing cardiovascular disease in high-risk individuals., has several other brand drugs using the same active ingredient (Rosuvastatin Calcium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Althera Pharms |
| |
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Rosuvastatin Calcium, Crestor's active ingredient. Check the complete list of approved generic manufacturers for Crestor
About Crestor
Crestor is a drug owned by Ipr Pharmaceuticals Inc. It is used for treating high cholesterol and preventing cardiovascular disease in high-risk individuals. Crestor uses Rosuvastatin Calcium as an active ingredient. Crestor was launched by Ipr in 2003.
Approval Date:
Crestor was approved by FDA for market use on 12 August, 2003.
Active Ingredient:
Crestor uses Rosuvastatin Calcium as the active ingredient. Check out other Drugs and Companies using Rosuvastatin Calcium ingredient
Treatment:
Crestor is used for treating high cholesterol and preventing cardiovascular disease in high-risk individuals.
Dosage:
Crestor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 40MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |