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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: N215559

Product 003
PALOVAROTENE (SOHONOS) CAPSULE 2.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 9314439 08/31/2031 U-3676 09/07/2023
003 9789074 08/31/2031 U-3676 09/07/2023
003 10292954 08/31/2031 U-3676 09/07/2023
003 10864194 06/08/2037 U-3676 09/07/2023
003 11622959 06/08/2037 U-3676 09/07/2023

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003 NCE 08/16/2028
003 ODE-439 08/16/2030

 

 


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