Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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.

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Submission Date
001	8513263	12/23/2029	DS	DP		12/20/2018
001	8865698	10/21/2029			U-2469	12/20/2018
001	9127013	10/21/2029	DS	DP		12/20/2018
001	9447104	10/21/2029			U-2470	12/20/2018
001	9676783	10/21/2029			U-2469	12/20/2018
001	9782414	11/16/2035			U-2471	12/20/2018
001	10005783	10/21/2029			U-2472	12/20/2018
001	10045991	04/04/2037			U-2473	12/20/2018
001	10047097	10/21/2029			U-2474	12/20/2018
001	10137127	04/04/2037		DP		12/20/2018
001	10172861	11/16/2035	DS			06/13/2019
001	10668072	04/04/2037		DP		09/17/2020
001	10774085	10/21/2029			U-2470	10/14/2020
001	10799505	08/15/2036	DS			04/01/2021
001	11191766	04/04/2037			U-2471	03/10/2023
001	11484535	04/04/2037			U-2470	03/10/2023