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: N208799

Product 003
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE (AIRDUO RESPICLICK) POWDER 0.232MG/INH;EQ 0.014MG BASE/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 6701917 06/23/2021 DP
01/30/2017
003 6718972 06/23/2021 DP
01/30/2017
003 6748947 06/23/2021 DP
01/30/2017
003 6871646 06/23/2021 DP
01/30/2017
003 7540282 05/06/2023 DP
01/30/2017
003 8006690 06/23/2021 DP
01/30/2017
003 8651103 03/26/2028 DP
01/30/2017
003 8714149 02/25/2032 DP
01/30/2017
003 8978966 01/13/2032 DP
01/30/2017
003 9066957 10/06/2034 DP
U-645 TREATMENT OF ASTHMA
01/30/2017
003 9216260 06/28/2031 DP
01/30/2017
003 9463288 05/19/2025 DP
01/30/2017
003 9616024 09/01/2024 DP
05/10/2017
003 9731087 05/18/2031 DP
08/31/2017
003 9987229 09/01/2024 DP
07/03/2018
003 10022510 05/18/2031 DP
08/13/2018
003 10124131 05/18/2031 DP
12/12/2018
003 10195375 02/14/2031 DP
03/05/2019
003 10561808 01/01/2032 DP
03/19/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
01/27/2020

 

 


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