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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: N022287

Product 001
DEXLANSOPRAZOLE (DEXILANT) CAPSULE, 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-949 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
U-950 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
U-951 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
U-1507 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
001 6664276*PED 07/30/2023
001 7790755 08/02/2026 DP
09/29/2010
001 7790755*PED 02/02/2027
001 8105626 09/27/2026 DP
02/28/2012
001 8105626*PED 03/27/2027
001 8173158 03/17/2030
U-949 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
U-950 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
U-951 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
06/01/2012
001 8173158*PED 09/17/2030
001 8461187 01/17/2026 DP
001 8461187*PED 07/17/2026
001 8722084 10/15/2023 DP
06/09/2014
001 8722084*PED 04/15/2024
001 8784885 10/15/2023 DP
U-1552 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
U-1553 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
U-1554 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL DISEASE (GERD)
08/19/2014
001 8784885*PED 04/15/2024
001 8871273 01/11/2028 DP
12/01/2014
001 9011926 02/24/2026 DP
05/01/2015
001 9233103 03/05/2032
U-1805 USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS
02/11/2016
001 9238029 01/17/2026 DP
02/11/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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