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	8865730	03/05/2033	DS	DP	U-1615	11/18/2014
001	8980901	05/12/2025			U-1678	04/10/2015
001	9149477	05/12/2025			U-1757	11/03/2015
001	9469643	09/02/2033	DS			11/16/2016
001	9492449	03/11/2030			U-1914	11/16/2016
001	10730879	03/05/2033	DS	DP		09/03/2020
001	RE44599	07/21/2025			U-1558 U-1615	08/21/2014
001	RE44638	08/05/2025	DS	DP		08/21/2014

Product No	Exclusivity Code	Exclusivity Expiration