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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: N022030

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6858650 07/03/2022 DS U-913
001 6858650*PED 01/03/2023
001 7807715 06/07/2027 DP U-913
001 7807715*PED 12/07/2027
001 8088398 06/07/2027 DP U-913
001 8088398*PED 12/07/2027
001 8501723 06/07/2027 DP 08/20/2013
001 8501723*PED 12/07/2027

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-861 06/17/2024
001 I-861 *PED 12/17/2024



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View a list of all exclusivity codes

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