Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N022334

Product 003
EVEROLIMUS (AFINITOR) TABLET 2.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 8410131 11/01/2025
U-1368 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
04/02/2013
003 8410131*PED 05/01/2026
003 8436010 02/22/2022
U-1396 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
06/03/2013
003 8436010*PED 08/22/2022
003 8778962 02/18/2022
U-1541 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
07/28/2014
003 8778962*PED 08/18/2022
003 9006224 07/01/2028
U-1681 TREATMENT OF PATIENTS WITH PROGESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
04/20/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003
ODE-108TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
COMPETITIVE GENERIC THERAPY
02/26/2023

 

 


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