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: N202107

Product 001
MIFEPRISTONE (KORLYM) TABLET 300MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 10006924 08/12/2036
U-1643 TREATING CUSHING'S SYNDROME
07/10/2018
001 10151763 01/18/2037
U-1643 TREATING CUSHING'S SYNDROME
12/12/2018
001 10166242 04/20/2036
U-1643 TREATING CUSHING'S SYNDROME
01/02/2019
001 10166243 04/20/2036
U-1643 TREATING CUSHING'S SYNDROME
01/02/2019
001 10195214 06/19/2037
U-1643 TREATING CUSHING'S SYNDROME
02/05/2019
001 10231983 08/22/2038
U-1643 TREATING CUSHING'S SYNDROME
04/03/2019
001 10314850 08/22/2038
U-1643 TREATING CUSHING'S SYNDROME
06/14/2019
001 8921348 08/27/2028
U-1643 TREATING CUSHING'S SYNDROME
01/27/2015
001 9829495 08/15/2036
U-1643 TREATING CUSHING'S SYNDROME
11/28/2017
001 9943526 04/20/2036
U-1643 TREATING CUSHING'S SYNDROME
04/17/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
ODE-22 FOR THE CONTROL OF HYPERGLYCEMIA SECONDARY TO HYPERCORTISOLISM IN ADULT PATIENTS WITH ENDOGENOUS CUSHING'S SYNDROME WHO HAVE TYPE 2 DIABETES MELLITUS OR GLUCOSE INTOLERANCE AND HAVE FAILED SURGERY OR ARE NOT CANDIDATES FOR SURGERY
ONCE A DAY APPLICATION
02/17/2019

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