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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: N208259

Product 001
LATANOPROST; NETARSUDIL DIMESYLATE (ROCKLATAN) SOLUTION/DROPS 0.005%;EQ 0.02% BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8394826 11/10/2030 DS DP U-1524 03/28/2019
001 8450344 07/11/2026 DS DP U-1524 03/28/2019
001 9096569 07/11/2026 DS DP U-1524 03/28/2019
001 9415043 03/14/2034 DS 03/28/2019
001 9931336 03/14/2034 DS DP U-1524 03/28/2019
001 9993470 03/14/2034 DS DP U-1524 03/28/2019
001 10174017 01/27/2030 DS DP U-1524 03/28/2019
001 10532993 07/11/2026 U-1524 03/30/2020
001 10588901 03/14/2034 DS DP U-1524 04/15/2020
001 10654844 01/27/2030 DS DP U-1524 06/10/2020
001 10882840 07/11/2026 U-1524 01/22/2021
001 11021456 07/11/2026 U-1524 06/28/2021
001 11028081 01/27/2030 U-1524 06/28/2021
001 11185538 03/14/2034 DP 12/16/2021
001 11197853 03/14/2034 DP 12/16/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NC 03/12/2022
001 NCE 12/18/2022

 

 


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