Sunitinib Malate Patent Expiration

Sunitinib Malate is Used for treating gastrointestinal stromal tumors and protein kinase related disorders, such as renal cell carcinoma and advanced pancreatic neuroendocrine tumors. It was first introduced by Cp Pharmaceuticals International Cv in its drug Sutent on Jan 26, 2006. 9 different companies have introduced drugs containing Sunitinib Malate.


Sunitinib Malate Patents

Given below is the list of patents protecting Sunitinib Malate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sutent US6573293

(Pediatric)

Pyrrole substituted 2-indolinone protein kinase inhibitors Aug 15, 2021

(Expired)

Cppi Cv
Sutent US7125905

(Pediatric)

Pyrrole substituted 2-indolinone protein kinase inhibitors Aug 15, 2021

(Expired)

Cppi Cv
Sutent US7211600

(Pediatric)

Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds Jun 22, 2021

(Expired)

Cppi Cv
Sutent US6573293 Pyrrole substituted 2-indolinone protein kinase inhibitors Feb 15, 2021

(Expired)

Cppi Cv
Sutent US7125905 Pyrrole substituted 2-indolinone protein kinase inhibitors Feb 15, 2021

(Expired)

Cppi Cv
Sutent US7211600 Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds Dec 22, 2020

(Expired)

Cppi Cv



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 Sunitinib Malate's patents.

Given below is the list recent legal activities going on the following patents of Sunitinib Malate.

Activity Date Patent Number
Patent litigations
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 06 Apr, 2016 US6573293(Litigated)
Patent Term Extension Certificate 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 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)


Sunitinib Malate's Family Patents

Family Patents

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Sunitinib Malate Generic API Manufacturers

Several generic applications have been filed for Sunitinib Malate. The first generic version for Sunitinib Malate was by Sun Pharmaceutical Industries Ltd and was approved on Aug 16, 2021. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Feb 14, 2025.

Given below is the list of companies who have filed for Sunitinib Malate generic, along with the locations of their manufacturing plants worldwide.