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 005
SELEXIPAG (UPTRAVI) TABLET 1MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
005	7205302	10/31/2026	DS	DP	U-1797		01/19/2016
005	7205302*PED	04/30/2027
005	8791122	08/01/2030	DS	DP			01/19/2016
005	8791122*PED	02/01/2031
005	9173881	08/12/2029			U-1798		01/19/2016
005	9173881*PED	02/12/2030
005	9284280	06/25/2030			U-1831		04/12/2016
005	9284280*PED	12/25/2030
005	10821108	12/01/2036		DP	U-2992		12/02/2020
005	10821108*PED	06/01/2037
005	10828298	12/01/2036		DP	U-2991		12/02/2020
005	10828298*PED	06/01/2037

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
005	NPP	05/23/2029
005	NPP *PED	11/23/2029

 

 

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