Generic Sutent Availability

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 [AB], EQ 25MG BASE [AB], EQ 50MG BASE [RLD] [AB]
  • Manufacturer: CPPI CV
    Approval date: March 31, 2009
    Strength(s): EQ 37.5MG BASE [AB]

Has a generic version of Sutent been approved?

A generic version of Sutent has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Sutent and have been approved by the FDA:

sunitinib malate capsule;oral

  • Manufacturer: MYLAN PHARMS INC
    Approval date: January 30, 2014
    Strength(s): EQ 12.5MG BASE [AB], EQ 25MG BASE [AB], EQ 37.5MG BASE [AB], EQ 50MG BASE [AB]

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
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      Patent use: TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB
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  • 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
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  • 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
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      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:
    • May 20, 2014 - TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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