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: N019430

Product 001
EPINEPHRINE (EPIPEN) INJECTABLE 0.3MG/DELIVERY

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7449012 09/11/2025 DP
001 7794432 09/11/2025 DP
001 8048035 09/11/2025 DP
11/25/2011
001 8870827 09/11/2025 DP
10/30/2014
001 9586010 09/11/2025 DP
05/12/2017

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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