Sutent

Sutent is a brand name of sunitinib, approved by the FDA in the following formulation(s):

SUTENT (sunitinib malate - capsule; oral)

• 
  Manufacturer: CPPI CV
  
  Approval date: January 26, 2006
  
  Strength(s): EQ 12.5MG BASE, EQ 25MG BASE, EQ 50MG BASE ^[RLD]


• 
  Manufacturer: CPPI CV
  
  Approval date: March 31, 2009
  
  Strength(s): EQ 37.5MG BASE
  

Has a generic version of Sutent been approved?

No. There is currently no therapeutically equivalent version of Sutent available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sutent. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Pyrrole substituted 2-indolinone protein kinase inhibitors
  Patent 6,573,293
  Issued: June 3, 2003
  Inventor(s): Peng Cho; Tang & Todd A.; Miller & Xiaoyuan; Li & Li; Sun & Chung Chen; Wei & Shahrzad; Shirazian & Congxin; Liang & Tomas; Vojkovsky & Asaad S.; Nematalla & Michael; Hawley
  Assignee(s): Sugen, Inc.
  Pharmacia & Upjohn Co.
  The present invention relates to pyrrole substituted 2-indolinone compounds and their pharmaceutically acceptable salts which modulate the activity of protein kinases and therefore are expected to be useful in the prevention and treatment of protein kinase related cellular disorders such as cancer.
  
  Patent expiration dates:
  
  
  • February 15, 2021
    
    ✓ 
    Patent use: TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  



• 
  Pyrrole substituted 2-indolinone protein kinase inhibitors
  Patent 7,125,905
  Issued: October 24, 2006
  Inventor(s): Tang; Peng Cho & Miller; Todd A. & Li; Xiaoyuan & Sun; Li & Wei; Chung Chen & Shirazian; Shahrzad & Liang; Congxin & Vojkovsky; Tomas & Nematalla; Asaad S. & Hawley; Michael
  Assignee(s): Agouron Pharmaceuticals, Inc.
  The present invention relates to pyrrole substituted 2-indolinone compounds and their pharmaceutically acceptable salts which modulate the activity of protein kinases and therefore are expected to be useful in the prevention and treatment of protein kinase related cellular disorders such as cancer.
  
  Patent expiration dates:
  
  
  • February 15, 2021
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  



• 
  Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds
  Patent 7,211,600
  Issued: May 1, 2007
  Inventor(s): Lipson; Ken & McMahon; Gerald
  Assignee(s): Sugen Inc.
  The present invention concerns compounds and their use to inhibit the activity of a receptor tyrosine kinase. The invention is preferably used to treat cell proliferative disorders such as cancers characterized by over-activity or inappropriate activity c-kit kinase.
  
  Patent expiration dates:
  
  
  • December 22, 2020
    
    ✓ 
    Patent use: TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • January 26, 2011 - NEW CHEMICAL ENTITY
  
  
  • May 20, 2014 - TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE
  
  

See also...

• Sutent Consumer Information (Wolters Kluwer)
• Sutent Consumer Information (Cerner Multum)
• Sutent Advanced Consumer Information (Micromedex)
• Sutent AHFS DI Monographs (ASHP)
• Sunitinib Consumer Information (Wolters Kluwer)
• Sunitinib Consumer Information (Cerner Multum)
• Sunitinib Advanced Consumer Information (Micromedex)
• Sunitinib malate Advanced Consumer Information (Micromedex)
• Sunitinib Malate AHFS DI Monographs (ASHP)