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: N210933

Product 001
LOTEPREDNOL ETABONATE (EYSUVIS) SUSPENSION/DROPS 0.25%

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9056057 05/03/2033 DP
U-2491 A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
11/20/2020
001 9393213 05/03/2033 DP
11/20/2020
001 9532955 05/03/2033
U-2491 A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
11/20/2020
001 9737491 05/03/2033
U-2492 A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
11/20/2020
001 9827191 05/03/2033 DP
U-2985 A METHOD FOR TREATING DRY EYE IN A PATIENT
11/20/2020
001 10058511 05/03/2033 DP
U-2492 A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
11/20/2020
001 10646436 05/03/2033 DP
11/20/2020
001 10688045 05/03/2033 DP
11/20/2020
001 10857096 05/03/2033
U-2985 A METHOD FOR TREATING DRY EYE IN A PATIENT
12/28/2020
001 10940108 05/03/2033
U-2985 A METHOD FOR TREATING DRY EYE IN A PATIENT
03/30/2021
001 10945948 05/03/2033
U-2985 A METHOD FOR TREATING DRY EYE IN A PATIENT
03/30/2021
001 10993908 05/03/2033
U-3117 ADMINISTRATION TO THE EYE OF A PATIENT FOR TREATMENT OF DRY EYE CONDITION
05/26/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
10/26/2023

 

 


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