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 Product	Patent Use Code	Submission Date
001	8252331	03/13/2030	DP		03/01/2018
001	8389578	01/22/2028		U-219 U-3054	02/10/2021
001	8574626	11/28/2025	DP	U-20	03/01/2018
001	8796337	11/23/2025		U-219 U-2497 U-3054	02/10/2021
001	8889740	11/23/2025	DP		02/10/2021
001	8895614	11/23/2025	DP		02/10/2021
001	8895615	11/23/2025		U-219 U-3054	02/10/2021
001	8895616	11/23/2025		U-219 U-3054	02/10/2021
001	8895617	11/23/2025		U-219 U-3054	02/10/2021
001	8895618	11/23/2025	DP		02/10/2021
001	8987333	11/23/2025	DP		02/10/2021
001	9072697	11/23/2025		U-219 U-3054	02/10/2021
001	10213393	02/15/2038		U-20	03/13/2019
001	10213394	02/15/2038		U-2497	03/13/2019
001	10500170	02/15/2038		U-20	12/17/2019
001	10500171	02/15/2038		U-2497	12/17/2019
001	10500172	02/15/2038		U-2497	12/17/2019
001	10512617	02/15/2038		U-2497	01/02/2020
001	11890261	02/15/2038		U-2497	03/04/2024

Product No	Exclusivity Code	Exclusivity Expiration