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: N022315

Product 001
DEXAMETHASONE (OZURDEX) IMPLANT 0.7MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6899717 11/01/2023
U-1206 DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THE APPROVED LABELING OF OZURDEX
001 8034366 01/09/2023 DP
U-1204 TREATMENT OF UVEITIS
U-1205 TREATMENT OF MACULAR EDEMA
12/23/2011
001 8034370 01/09/2023 DP
12/23/2011
001 8506987 01/09/2023
U-1204 TREATMENT OF UVEITIS
U-1205 TREATMENT OF MACULAR EDEMA
09/11/2013
001 9192511 01/09/2023 DP
12/21/2015
001 10076526 01/09/2023 DP
10/17/2018
001 10702539 01/09/2023
U-985 TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL RETINAL VEIN OCCLUSION (CRVO)
U-1597 TREATMENT OF DIABETIC MACULAR EDEMA
U-2868 TREATMENT OF NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
08/07/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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