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: N212268

Product 003
ASENAPINE (SECUADO) SYSTEM 7.6MG/24HR

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 9687474 07/25/2033 DP
10/18/2019
003 10022445 07/25/2033 DP
10/18/2019
003 10583121 07/25/2033 DP
U-2763 METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH
03/27/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
10/11/2022

 

 


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