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: N022416

Product 003
ESLICARBAZEPINE ACETATE (APTIOM) TABLET 600MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 8372431 04/17/2030 DP
003 9206135 04/21/2026 DS
05/20/2016
003 9566244 10/23/2028 DP
03/08/2017
003 9643929 04/21/2026 DP
06/08/2017
003 9750747 08/24/2032
U-2041 TREATMENT OF PARTIAL-ONSET SEIZURES
U-2121 TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES
09/28/2017
003 9763954 09/13/2028
U-2123 TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE
10/10/2017
003 10675287 05/06/2025
U-2041 TREATMENT OF PARTIAL-ONSET SEIZURES
U-2831 TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
06/10/2020
003 10695354 05/06/2025
U-2501 TREATMENT OF PARTIAL-ONSET SEIZURES
U-2831 TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
06/30/2020
003 10702536 05/06/2025
U-2501 TREATMENT OF PARTIAL-ONSET SEIZURES
07/07/2020
003 10912781 10/23/2028 DP
02/10/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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