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
003	9694018	11/08/2031			U-3186 U-3187 U-3648 U-3649	08/18/2021
003	10011633	11/08/2031			U-3186 U-3187 U-3648 U-3649	08/18/2021
003	10093697	11/08/2031			U-3186 U-3187 U-3648 U-3649	08/18/2021
003	10487111	11/08/2031			U-3186 U-3187 U-3648 U-3649	08/18/2021
003	10975046	06/20/2039	DS			08/18/2021
003	10981952	11/08/2031			U-3186 U-3187 U-3648 U-3649	08/18/2021
003	11365182	06/20/2039			U-3186 U-3187 U-3648 U-3649	07/12/2022
003	11583539	11/12/2041			U-3186	03/20/2023
003	11732006	11/08/2031			U-3186 U-3187 U-3648 U-3649	09/21/2023
003	11801226	06/20/2039		DP		11/29/2023
003	11802115	06/20/2039		DP		11/29/2023