Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N207078

Product 001
SODIUM ZIRCONIUM CYCLOSILICATE (LOKELMA) FOR SUSPENSION 5GM/PACKET

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8802152	04/19/2032	DS				06/12/2018
001	8808750	02/10/2032			U-2312		06/12/2018
001	8877255	10/22/2033	DS				06/12/2018
001	9592253	10/14/2035	DS		U-2312		06/12/2018
001	9844567	02/10/2032			U-2312		06/12/2018
001	9861658	02/10/2032			U-2312		06/12/2018
001	9913860	10/22/2033	DS		U-2312		01/23/2019
001	10300087	10/14/2035	DS		U-2312		07/25/2019
001	10335432	02/10/2032			U-2312		07/25/2019
001	10398730	02/10/2032			U-2312		10/01/2019
001	10413569	02/10/2032	DS				10/01/2019
001	10695365	10/22/2033	DS				07/28/2020
001	11406662	02/10/2032	DS				09/07/2022
001	11738044	10/14/2035			U-2312		09/21/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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