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	7417148	12/11/2025			U-1283 U-3707 U-3708	11/15/2017
003	7417148*PED	06/11/2026
003	7767678	11/23/2026	DS	DP		11/15/2017
003	7767678*PED	05/23/2027
003	7919625	12/11/2025		DP		11/15/2017
003	7919625*PED	06/11/2026
003	11103497	02/28/2034			U-3216 U-3217	09/29/2021
003	11103497*PED	08/28/2034
003	RE42376	04/13/2024	DS			11/15/2017
003	RE42376*PED	10/13/2024