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: N207947

Product 008
SELEXIPAG (UPTRAVI) TABLET 1.6MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
008 7205302 04/04/2023 DS DP
U-1797 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
01/19/2016
008 8791122 08/01/2030 DS DP
01/19/2016
008 9173881 08/12/2029
U-1798 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
01/19/2016
008 9284280 06/25/2030
U-1831 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
04/12/2016
008 10821108 12/01/2036 DP
U-2992 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
12/02/2020
008 10828298 12/01/2036 DP
U-2991 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
12/02/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
008
ODE-106FOR USE OF UPTRAVI (SELEXIPAG) TABLETS, 200, 400, 600, 800, 1000, 1200, 1400, AND 1600 MCG FOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I) TO REDUCE THE RISKS OF DISEASE PROGRESSION AND HOSPITALIZATION FOR PAH
COMPETITIVE GENERIC THERAPY
12/21/2022

 

 


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