Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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.

Patent and Exclusivity for: N207318

Product 002
PIMAVANSERIN TARTRATE (NUPLAZID) TABLET EQ 10MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7601740	04/29/2030	DS	DP			07/25/2018
002	7659285	08/24/2026			U-1844		07/25/2018
002	7732615	06/03/2028	DS	DP			07/25/2018
002	7923564	09/26/2025	DS	DP			07/25/2018
002	8618130	01/15/2024			U-1845		07/25/2018
002	8921393	01/15/2024			U-1846		07/25/2018
002	9566271	01/15/2024			U-1974		07/25/2018
002	10028944	01/15/2024			U-1974		07/25/2018
002	10517860	03/23/2037			U-1974		01/10/2020
002	10953000	03/23/2037			U-1974		03/30/2021

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

View a list of all patent use codes
View a list of all exclusivity codes