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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: N208056

Product 001
DEXLANSOPRAZOLE (DEXILANT SOLUTAB) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6664276 01/30/2023 DS DP U-950 U-951 02/25/2016
001 6664276*PED 07/30/2023
001 8461187 01/17/2026 DP 02/25/2016
001 8461187*PED 07/17/2026
001 8784885 10/15/2023 DP 02/25/2016
001 8784885*PED 04/15/2024
001 8871273 01/11/2028 DP 02/25/2016
001 8871273*PED 07/11/2028
001 9011926 02/24/2026 DP 02/25/2016
001 9238029 01/17/2026 DP 02/25/2016
001 9241910 03/10/2029 DP

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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