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	8198242	06/11/2035	DS	DP	U-3927	12/17/2021
003	9907834	08/01/2036		DP		12/17/2021
003	10646550	08/01/2036		DP	U-3927	12/17/2021
003	11590204	08/01/2036		DP	U-3927	05/20/2024
003	11911446	08/01/2036			U-3927	05/20/2024
003	12233106	07/11/2042			U-3927	03/21/2025
003	12514906	08/01/2036		DP	U-3927	02/03/2026
003	RE48267	05/20/2030			U-3927	12/17/2021