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: N206406

Product 002
TACROLIMUS (ENVARSUS XR) TABLET, EXTENDED RELEASE EQ 1MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7994214 08/30/2024 DP
08/24/2015
002 8486993 08/30/2024 DP
U-1752 PROPHYLAXIS OF ORGAN REJECTION
08/24/2015
002 8586084 08/30/2024
U-1752 PROPHYLAXIS OF ORGAN REJECTION
08/24/2015
002 8591946 08/30/2024 DP
08/24/2015
002 8617599 08/30/2024 DP
08/24/2015
002 8623410 08/30/2024 DP
08/24/2015
002 8623411 08/30/2024
U-1752 PROPHYLAXIS OF ORGAN REJECTION
08/24/2015
002 8664239 08/30/2028
U-1752 PROPHYLAXIS OF ORGAN REJECTION
U-2677 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
U-2678 PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
08/24/2015
002 8685998 08/30/2028 DP
U-1752 PROPHYLAXIS OF ORGAN REJECTION
U-2677 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
U-2678 PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
08/24/2015
002 8889185 08/30/2024
U-1752 PROPHYLAXIS OF ORGAN REJECTION
08/24/2015
002 8889186 08/30/2024
U-1752 PROPHYLAXIS OF ORGAN REJECTION
08/24/2015
002 9161907 08/30/2024 DP
U-1752 PROPHYLAXIS OF ORGAN REJECTION
11/13/2015
002 9549918 05/30/2028 DP
05/02/2017
002 9757362 08/30/2024 DP
12/20/2017
002 9763920 08/30/2024 DP
12/20/2017
002 10166190 05/30/2028 DP
02/14/2019
002 10548880 08/30/2024
U-2677 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
U-2678 PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
07/28/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
ODE-94PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY TRANSPLANT PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
COMPETITIVE GENERIC THERAPY
07/10/2022

 

 


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