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 7731686 06/01/2026 DP
002 7731690 01/15/2025 DP
002 7749194 10/30/2028 DP
002 7918823 11/23/2024 DP
002 7947017 03/12/2028 DP
002 8016788 03/21/2025 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 8920377 11/23/2024 DP
01/29/2015
002 8926594 03/31/2026 DP
02/05/2015
002 9056170 11/23/2024 DP
07/16/2015
002 9149579 07/19/2025
U-1758 METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
11/06/2015
002 9238108 02/20/2027 DP
02/18/2016
002 9259539 02/01/2026 DP
03/23/2016
002 9278182 02/01/2026 DP
04/11/2016
002 9724471 05/23/2027 DP
U-2092 METHOD FOR CONFIRMING DOSE DELIVERY
08/23/2017
002 9737669 11/23/2024 DP
08/30/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
There is no unexpired exclusivity for this product in the Orange Book database.

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

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