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: N207356

Product 001
AMIKACIN SULFATE (ARIKAYCE KIT) SUSPENSION, LIPOSOMAL EQ 590MG BASE/8.4ML

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7718189	06/06/2025		DP	U-2415		10/24/2018
001	8226975	08/15/2028		DP			10/24/2018
001	8632804	12/05/2026			U-2416		10/24/2018
001	8642075	12/05/2026		DP			10/24/2018
001	8679532	12/05/2026			U-2415		10/24/2018
001	8802137	04/08/2024		DP	U-2414		10/24/2018
001	9566234	01/18/2034		DP	U-2415		10/24/2018
001	9827317	04/08/2024		DP	U-2415		10/24/2018
001	9895385	05/15/2035			U-2417		10/24/2018
001	10251900	05/15/2035			U-2414		05/02/2019
001	10751355	05/15/2035			U-2414		09/24/2020
001	11446318	05/15/2035			U-2414		10/14/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-214	09/28/2025
001	ODE-214 *GAIN	09/28/2030

 

 

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