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: N021528

Product 001
KETOROLAC TROMETHAMINE (ACULAR LS) SOLUTION/DROPS 0.4%

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8008338	05/24/2027	DS	DP	U-1181		09/23/2011
001	8008338*PED	11/24/2027
001	8207215	05/28/2024			U-1251		07/23/2012
001	8207215*PED	11/28/2024
001	8377982	05/28/2024			U-1363		03/18/2013
001	8377982*PED	11/28/2024
001	8541463	05/28/2024			U-1441		10/22/2013
001	8541463*PED	11/28/2024
001	8648107	05/28/2024		DP			03/04/2014
001	8906950	05/28/2024			U-1626		01/08/2015
001	8946281	05/28/2024			U-1662		03/04/2015
001	9216167	05/28/2024			U-1800		01/20/2016

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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