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 005
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE (AIRDUO DIGIHALER) POWDER 0.113MG/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
005 6701917 06/23/2021 DP
08/02/2019
005 6718972 06/23/2021 DP
08/02/2019
005 6748947 06/23/2021 DP
08/02/2019
005 6871646 06/23/2021 DP
08/02/2019
005 7540282 05/06/2023 DP
08/02/2019
005 7540282*PED 11/06/2023
005 8006690 06/23/2021 DP
08/02/2019
005 8651103 03/26/2028 DP
08/02/2019
005 8651103*PED 09/26/2028
005 8714149 02/25/2032 DP
08/02/2019
005 8714149*PED 08/25/2032
005 8978966 01/13/2032 DP
08/02/2019
005 8978966*PED 07/13/2032
005 9066957 10/06/2034 DP
U-645 TREATMENT OF ASTHMA
08/02/2019
005 9066957*PED 04/06/2035
005 9216260 06/28/2031 DP
08/02/2019
005 9216260*PED 12/28/2031
005 9463288 05/19/2025 DP
08/02/2019
005 9463288*PED 11/19/2025
005 9616024 09/01/2024 DP
08/02/2019
005 9616024*PED 03/01/2025
005 9731087 05/18/2031 DP
08/02/2019
005 9731087*PED 11/18/2031
005 9782550 08/28/2035 DP
08/02/2019
005 9782550*PED 02/28/2036
005 9782551 08/28/2035 DP
08/02/2019
005 9782551*PED 02/28/2036
005 9987229 09/01/2024 DP
08/02/2019
005 9987229*PED 03/01/2025
005 10022510 05/18/2031 DP
08/02/2019
005 10022510*PED 11/18/2031
005 10124131 05/18/2031 DP
08/02/2019
005 10124131*PED 11/18/2031
005 10195375 02/14/2031 DP
08/02/2019
005 10195375*PED 08/14/2031
005 10561808 01/01/2032 DP
03/19/2020
005 10561808*PED 07/01/2032
005 10569034 08/16/2036 DP
03/12/2020
005 10569034*PED 02/16/2037
005 10765820 05/19/2025 DP
10/06/2020
005 10765820*PED 11/19/2025
005 10918816 12/14/2035 DP
03/18/2021
005 10918816*PED 06/14/2036
005 11000653 12/18/2038 DP
06/10/2021
005 11000653*PED 06/18/2039

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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