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: N208073

Product 001
LIFITEGRAST (XIIDRA) SOLUTION/DROPS 5%

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7314938 03/10/2025 DS DP
08/03/2016
001 7745460 11/05/2024 DS DP
U-1880 TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
08/03/2016
001 7790743 11/05/2024
U-1880 TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
08/03/2016
001 7928122 11/05/2024 DS DP
08/03/2016
001 8084047 05/17/2026 DS DP
08/03/2016
001 8168655 05/09/2029
U-1880 TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
08/03/2016
001 8367701 04/15/2029 DP
U-1880 TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
08/03/2016
001 8592450 05/17/2026
U-1880 TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
08/03/2016
001 8927574 11/12/2030 DP
08/03/2016
001 9085553 07/25/2033 DP
08/03/2016
001 9216174 11/05/2024 DP
08/03/2016
001 9353088 10/21/2030 DP
08/03/2016
001 9447077 04/15/2029
U-1900 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
10/06/2016
001 9890141 10/21/2030 DS
03/05/2018
001 10124000 11/05/2024
U-1900 TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
12/06/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
07/11/2021

 

 


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