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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: N211150

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8207197 03/07/2030 DS DP 09/11/2019
001 8354430 02/06/2026 U-1101 U-1102 09/11/2019
001 8486947 09/26/2029 U-1101 U-1102 09/11/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NCE 08/14/2024
001 ODE-255 08/14/2026
001 ODE-331 10/13/2027



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

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