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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: N202611

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7342117*PED 05/04/2024
001 7982049*PED 05/04/2024
001 8772315 10/30/2028 U-2300 05/17/2018
001 8772315*PED 04/30/2029
001 8835474*PED 05/04/2024
001 10842780 09/28/2029 DP U-2996 U-3670 12/11/2020
001 10842780*PED 03/28/2030
001 11707451 09/28/2029 U-2996 U-3670 08/21/2023
001 11707451*PED 03/28/2030
001 RE44872*PED 05/04/2024

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-855 03/25/2024
001 I-855 *PED 09/25/2024



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View a list of all exclusivity codes

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