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: N203565

Product 001
FERRIC CARBOXYMALTOSE (INJECTAFER) SOLUTION 750MG IRON/15ML (50MG IRON/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7612109	02/05/2025	DS	DP			09/12/2013
001	7754702	02/15/2028			U-1432 U-2555 U-2556 U-2557 U-3312 U-3313 U-3314 U-3636		09/12/2013
001	8895612	01/08/2027			U-1620 U-3050 U-3051 U-3115 U-3116 U-3315 U-3316 U-3635		12/17/2014
001	11364260	01/08/2027			U-3637		06/28/2023
001	11433091	01/08/2027			U-3435 U-3436 U-3437 U-3438 U-3634		10/04/2022
001	11478502	01/08/2027			U-3472 U-3473 U-3474		11/21/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NPP	11/19/2024
001	I-915	05/31/2026

 

 

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