Home Applications 203496 Application 203496
Type NDA
Sponsor UNITED THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORENITRAM TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL EQ 0.125MG BASE Yes No 002 ORENITRAM TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL EQ 0.25MG BASE Yes No 003 ORENITRAM TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE Yes Yes 004 ORENITRAM TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL EQ 2.5MG BASE Yes No 005 ORENITRAM TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL EQ 5MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203496-001 ORENITRAM TREPROSTINIL DIOLAMINE EQ 0.125MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 N203496-002 ORENITRAM TREPROSTINIL DIOLAMINE EQ 0.25MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 N203496-003 ORENITRAM TREPROSTINIL DIOLAMINE EQ 1MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2013-12-20 N203496-004 ORENITRAM TREPROSTINIL DIOLAMINE EQ 2.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 N203496-005 ORENITRAM TREPROSTINIL DIOLAMINE EQ 5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2016-10-07
Orange Book patents# Current patent rows page 1 of 1 · 45 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203496-001 9393203 2026-04-27 U-1877 Drug product 2016-07-22 N203496-001 7417070 2026-07-30 Drug substance 2014-01-09 N203496-001 11723887 2028-12-15 Drug substance 2023-08-15 N203496-001 9593066 2028-12-15 Drug substance 2017-03-14 N203496-001 9604901 2028-12-15 Drug substance, Delist requested 2017-03-28 N203496-001 8410169 2030-02-13 Drug product 2014-01-09 N203496-001 8349892 2031-01-22 Drug product 2014-01-09 N203496-001 8747897 2031-08-11 U-2724 Drug product 2014-06-13 N203496-001 8747897 2031-08-11 U-2725 Drug product 2014-06-13 N203496-002 9393203 2026-04-27 U-1877 Drug product 2016-07-22 N203496-002 7417070 2026-07-30 Drug substance 2014-01-09 N203496-002 11723887 2028-12-15 Drug substance 2023-08-15 N203496-002 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 N203496-002 9593066 2028-12-15 Drug substance 2017-03-14 N203496-002 8410169 2030-02-13 Drug product 2014-01-09 N203496-002 8349892 2031-01-22 Drug product 2014-01-09 N203496-002 8747897 2031-08-11 U-2724 Drug product 2014-06-13 N203496-002 8747897 2031-08-11 U-2725 Drug product 2014-06-13 N203496-003 9393203 2026-04-27 U-1877 Drug product 2016-07-22 N203496-003 7417070 2026-07-30 Drug substance 2014-01-09 N203496-003 11723887 2028-12-15 Drug substance 2023-08-15 N203496-003 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 N203496-003 9593066 2028-12-15 Drug substance 2017-03-14 N203496-003 8410169 2030-02-13 Drug product 2014-01-09 N203496-003 8349892 2031-01-22 Drug product 2014-01-09 N203496-003 8747897 2031-08-11 U-2724 Drug product 2014-06-13 N203496-003 8747897 2031-08-11 U-2725 Drug product 2014-06-13 N203496-004 9393203 2026-04-27 U-1877 Drug product 2016-07-22 N203496-004 7417070 2026-07-30 Drug substance 2014-01-09 N203496-004 11723887 2028-12-15 Drug substance 2023-08-15 N203496-004 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 N203496-004 9593066 2028-12-15 Drug substance 2017-03-14 N203496-004 8410169 2030-02-13 Drug product 2014-01-09 N203496-004 8349892 2031-01-22 Drug product 2014-01-09 N203496-004 8747897 2031-08-11 U-2724 Drug product 2014-06-13 N203496-004 8747897 2031-08-11 U-2725 Drug product 2014-06-13 N203496-005 9393203 2026-04-27 U-1877 Drug product 2017-02-09 N203496-005 7417070 2026-07-30 Drug substance 2017-02-09 N203496-005 11723887 2028-12-15 Drug substance 2023-08-15 N203496-005 9593066 2028-12-15 Drug substance 2017-03-14 N203496-005 9604901 2028-12-15 Drug substance, Delist requested 2017-03-28 N203496-005 8410169 2030-02-13 Drug product 2017-02-09 N203496-005 8349892 2031-01-22 Drug product 2017-02-09 N203496-005 8747897 2031-08-11 U-2724 Drug product 2017-02-09 N203496-005 8747897 2031-08-11 U-2725 Drug product 2017-02-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N203496-001 ORENITRAM EQ 0.125MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 ORENITRAM EQ 0.25MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 ORENITRAM EQ 1MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2013-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 ORENITRAM EQ 2.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2013-12-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 ORENITRAM EQ 5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2016-10-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 45 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N203496-001 9393203 2026-04-27 U-1877 Drug product 2016-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 7417070 2026-07-30 Drug substance 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 9604901 2028-12-15 Drug substance, Delist requested 2017-03-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 8410169 2030-02-13 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 8349892 2031-01-22 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 8747897 2031-08-11 U-2725 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-001 8747897 2031-08-11 U-2724 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 9393203 2026-04-27 U-1877 Drug product 2016-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 7417070 2026-07-30 Drug substance 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 8410169 2030-02-13 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 8349892 2031-01-22 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 8747897 2031-08-11 U-2725 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 8747897 2031-08-11 U-2724 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 9393203 2026-04-27 U-1877 Drug product 2016-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 7417070 2026-07-30 Drug substance 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 8410169 2030-02-13 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 8349892 2031-01-22 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 8747897 2031-08-11 U-2724 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 8747897 2031-08-11 U-2725 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 9393203 2026-04-27 U-1877 Drug product 2016-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 7417070 2026-07-30 Drug substance 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 8497393 2028-12-15 Drug substance, Delist requested 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 8410169 2030-02-13 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 8349892 2031-01-22 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 8747897 2031-08-11 U-2725 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 8747897 2031-08-11 U-2724 Drug product 2014-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 9393203 2026-04-27 U-1877 Drug product 2017-02-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 7417070 2026-07-30 Drug substance 2017-02-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N203496-001 ODE-272 2026-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-002 ODE-272 2026-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-003 ODE-272 2026-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-004 ODE-272 2026-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N203496-005 ODE-272 2026-10-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 30 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66302-300 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-300 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-300 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-300 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-300 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-300 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-302 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-310 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-325 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corp. NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corporation NDA Current 66302-350 Orenitram treprostinil United Therapeutics Corp. NDA Current