Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N021938

Product 003
SUNITINIB MALATE (SUTENT) CAPSULE EQ 50MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 6573293 02/15/2021 DS DP
U-1154 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB
U-2171 ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RCC FOLLOWING NEPHRECTOMY
003 6573293*PED 08/15/2021
003 7125905 02/15/2021 DS DP
003 7125905*PED 08/15/2021
003 7211600*PED 06/22/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003
I-755ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RENAL CELL CARCINOMA (RCC) FOLLOWING NEPHRECTOMY
*PED PEDIATRIC EXCLUSIVITY
05/16/2021

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English