Sutent is a drug owned by Cp Pharmaceuticals International Cv. It is protected by 6 US drug patents filed from 2013 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2021. Details of Sutent'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). | |||
|
US6573293 (Pediatric) | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
|
US7125905 (Pediatric) | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
|
US7211600 (Pediatric) | Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds |
Jun, 2021
(3 years ago) |
Expired
|
| US6573293 | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Feb, 2021
(3 years ago) |
Expired
|
| US7125905 | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Feb, 2021
(3 years ago) |
Expired
|
| US7211600 | Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds |
Dec, 2020
(3 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 Sutent's patents.
Latest Legal Activities on Sutent's Patents
Given below is the list of recent legal activities going on the following patents of Sutent.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Oct, 2018 | US7211600 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Mar, 2018 | US7125905 (Litigated) |
| Patent Term Extension Certificate Critical | 06 Apr, 2016 | US6573293 (Litigated) |
| Patent Term Extension Certificate Critical | 17 Nov, 2015 | US6573293 (Litigated) |
| Notice of Final Determination -Eligible | 16 Jun, 2015 | US6573293 (Litigated) |
| Notice of Final Determination -Eligible | 23 Apr, 2015 | US6573293 (Litigated) |
| FDA Final Eligibility Letter Critical | 21 Jan, 2015 | US6573293 (Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 15 May, 2014 | US6573293 (Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 02 May, 2014 | US6573293 (Litigated) |
| Second letter to regulating agency to determine regulatory review period | 05 Sep, 2013 | US6573293 (Litigated) |
FDA has granted several exclusivities to Sutent. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sutent, 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 Sutent.
Exclusivity Information
Sutent holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Sutent's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-639) | May 20, 2014 |
| New Indication(I-755) | Nov 16, 2020 |
| Pediatric Exclusivity(PED) | May 16, 2021 |
US patents provide insights into the exclusivity only within the United States, but Sutent 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 Sutent's family patents as well as insights into ongoing legal events on those patents.
Sutent's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sutent's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 15, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sutent Generic API suppliers:
Sunitinib Malate is the generic name for the brand Sutent. 7 different companies have already filed for the generic of Sutent, with Dr Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sutent's generic
How can I launch a generic of Sutent before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sutent's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sutent'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 Sutent -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 mg, 25 mg, 37.5 mg and 50 mg | 26 Jan, 2010 | 1 | 15 Feb, 2021 | Extinguished |
About Sutent
Sutent is a drug owned by Cp Pharmaceuticals International Cv. It is used for treating gastrointestinal stromal tumors and protein kinase related disorders, such as renal cell carcinoma and advanced pancreatic neuroendocrine tumors. Sutent uses Sunitinib Malate as an active ingredient. Sutent was launched by Cppi Cv in 2006.
Approval Date:
Sutent was approved by FDA for market use on 26 January, 2006.
Active Ingredient:
Sutent uses Sunitinib Malate as the active ingredient. Check out other Drugs and Companies using Sunitinib Malate ingredient
Treatment:
Sutent is used for treating gastrointestinal stromal tumors and protein kinase related disorders, such as renal cell carcinoma and advanced pancreatic neuroendocrine tumors.
Dosage:
Sutent is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 37.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 12.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 50MG BASE | CAPSULE | Prescription | ORAL |