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	9018210	11/25/2033	DS	DP		12/19/2019
001	9248199	01/29/2034			U-2676 U-2715	12/19/2019
001	9447071	02/06/2035	DS	DP		12/19/2019
001	10017491	12/28/2032		DP		12/19/2019
001	10034879	12/28/2032	DS	DP		12/19/2019
001	10493035	10/12/2037		DP		12/19/2019
001	10722502	02/06/2035		DP		08/27/2020
001	10806733	12/28/2032	DS			11/19/2020
001	11020382	12/02/2036			U-3133 U-3134	06/23/2021
001	11452720	02/06/2035			U-3459	10/27/2022