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: N201739

Product 002
EPINEPHRINE (AUVI-Q) SOLUTION EQ 0.15MG/DELIVERY

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7947017	03/12/2028		DP
002	8021344	11/02/2029		DP			07/26/2013
002	8206360	02/27/2027		DP
002	8226610	04/10/2029		DP
002	8231573	11/25/2028		DP
002	8313466	11/23/2024		DP
002	8361029	11/23/2024		DP
002	8425462	11/23/2024		DP
002	8608698	11/23/2024		DP			01/15/2014
002	9737669	11/23/2024		DP			08/30/2017
002	10314977	11/23/2024		DP			06/11/2019
002	10335549	04/30/2025		DP			07/02/2019
002	10688244	12/21/2037		DP	U-2980		11/04/2020
002	10737028	11/23/2024		DP			08/25/2020
002	10842938	12/21/2037		DP	U-2980		12/10/2020
002	11590286	12/12/2026		DP			03/29/2023
002	11771830	12/21/2037		DP	U-2980		12/20/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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