Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N205388

Product 001
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE (OMIDRIA) SOLUTION EQ 0.3% BASE;EQ 1% BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8173707 07/30/2023
U-1518 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
06/13/2014
001 8173707*PED 01/30/2024
001 8586633 07/30/2023 DP
06/13/2014
001 8586633*PED 01/30/2024
001 9066856 10/23/2033 DP
07/13/2015
001 9066856*PED 04/23/2034
001 9278101 07/30/2023
U-1518 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
03/09/2016
001 9278101*PED 01/30/2024
001 9399040 07/30/2023 DP
07/28/2016
001 9399040*PED 01/30/2024
001 9486406 10/23/2033 DP
11/09/2016
001 9486406*PED 04/23/2034
001 9855246 10/23/2033 DP
01/05/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPPNEW PATIENT POPULATION
*PED PEDIATRIC EXCLUSIVITY
06/08/2021

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English