Application 203496

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 0.125MG BASEYesNo
002ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 0.25MG BASEYesNo
003ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 1MG BASEYesYes
004ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 2.5MG BASEYesNo
005ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 5MG BASEYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203496-001ORENITRAMTREPROSTINIL DIOLAMINEEQ 0.125MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-002ORENITRAMTREPROSTINIL DIOLAMINEEQ 0.25MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-003ORENITRAMTREPROSTINIL DIOLAMINEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2013-12-20
N203496-004ORENITRAMTREPROSTINIL DIOLAMINEEQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20
N203496-005ORENITRAMTREPROSTINIL DIOLAMINEEQ 5MG BASETABLET, EXTENDED RELEASE / ORALRLD2016-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203496-00193932032026-04-27U-1877Drug product2016-07-22
N203496-00174170702026-07-30Drug substance2014-01-09
N203496-001117238872028-12-15Drug substance2023-08-15
N203496-00195930662028-12-15Drug substance2017-03-14
N203496-00196049012028-12-15Drug substance, Delist requested2017-03-28
N203496-00184101692030-02-13Drug product2014-01-09
N203496-00183498922031-01-22Drug product2014-01-09
N203496-00187478972031-08-11U-2724Drug product2014-06-13
N203496-00187478972031-08-11U-2725Drug product2014-06-13
N203496-00293932032026-04-27U-1877Drug product2016-07-22
N203496-00274170702026-07-30Drug substance2014-01-09
N203496-002117238872028-12-15Drug substance2023-08-15
N203496-00284973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00295930662028-12-15Drug substance2017-03-14
N203496-00284101692030-02-13Drug product2014-01-09
N203496-00283498922031-01-22Drug product2014-01-09
N203496-00287478972031-08-11U-2724Drug product2014-06-13
N203496-00287478972031-08-11U-2725Drug product2014-06-13
N203496-00393932032026-04-27U-1877Drug product2016-07-22
N203496-00374170702026-07-30Drug substance2014-01-09
N203496-003117238872028-12-15Drug substance2023-08-15
N203496-00384973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00395930662028-12-15Drug substance2017-03-14
N203496-00384101692030-02-13Drug product2014-01-09
N203496-00383498922031-01-22Drug product2014-01-09
N203496-00387478972031-08-11U-2724Drug product2014-06-13
N203496-00387478972031-08-11U-2725Drug product2014-06-13
N203496-00493932032026-04-27U-1877Drug product2016-07-22
N203496-00474170702026-07-30Drug substance2014-01-09
N203496-004117238872028-12-15Drug substance2023-08-15
N203496-00484973932028-12-15Drug substance, Delist requested2014-01-09
N203496-00495930662028-12-15Drug substance2017-03-14
N203496-00484101692030-02-13Drug product2014-01-09
N203496-00483498922031-01-22Drug product2014-01-09
N203496-00487478972031-08-11U-2724Drug product2014-06-13
N203496-00487478972031-08-11U-2725Drug product2014-06-13
N203496-00593932032026-04-27U-1877Drug product2017-02-09
N203496-00574170702026-07-30Drug substance2017-02-09
N203496-005117238872028-12-15Drug substance2023-08-15
N203496-00595930662028-12-15Drug substance2017-03-14
N203496-00596049012028-12-15Drug substance, Delist requested2017-03-28
N203496-00584101692030-02-13Drug product2017-02-09
N203496-00583498922031-01-22Drug product2017-02-09
N203496-00587478972031-08-11U-2724Drug product2017-02-09
N203496-00587478972031-08-11U-2725Drug product2017-02-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203496-001ODE-2722026-10-18
N203496-002ODE-2722026-10-18
N203496-003ODE-2722026-10-18
N203496-004ODE-2722026-10-18
N203496-005ODE-2722026-10-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N203496-001ORENITRAMEQ 0.125MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20a50c72e98297…
2026-08-01 22:54:322026-06N203496-002ORENITRAMEQ 0.25MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20a50c72e98297…
2026-08-01 22:54:322026-06N203496-003ORENITRAMEQ 1MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2013-12-20a50c72e98297…
2026-08-01 22:54:322026-06N203496-004ORENITRAMEQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2013-12-20a50c72e98297…
2026-08-01 22:54:322026-06N203496-005ORENITRAMEQ 5MG BASETABLET, EXTENDED RELEASE / ORALRLD2016-10-07a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N203496-00193932032026-04-27U-1877Drug product2016-07-22a50c72e98297…
2026-08-01 22:54:322026-06N203496-00174170702026-07-30Drug substance2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-001117238872028-12-15Drug substance2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06N203496-00195930662028-12-15Drug substance2017-03-14a50c72e98297…
2026-08-01 22:54:322026-06N203496-00196049012028-12-15Drug substance, Delist requested2017-03-28a50c72e98297…
2026-08-01 22:54:322026-06N203496-00184101692030-02-13Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00183498922031-01-22Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00187478972031-08-11U-2725Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00187478972031-08-11U-2724Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00293932032026-04-27U-1877Drug product2016-07-22a50c72e98297…
2026-08-01 22:54:322026-06N203496-00274170702026-07-30Drug substance2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-002117238872028-12-15Drug substance2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06N203496-00284973932028-12-15Drug substance, Delist requested2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00295930662028-12-15Drug substance2017-03-14a50c72e98297…
2026-08-01 22:54:322026-06N203496-00284101692030-02-13Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00283498922031-01-22Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00287478972031-08-11U-2725Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00287478972031-08-11U-2724Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00393932032026-04-27U-1877Drug product2016-07-22a50c72e98297…
2026-08-01 22:54:322026-06N203496-00374170702026-07-30Drug substance2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-003117238872028-12-15Drug substance2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06N203496-00384973932028-12-15Drug substance, Delist requested2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00395930662028-12-15Drug substance2017-03-14a50c72e98297…
2026-08-01 22:54:322026-06N203496-00384101692030-02-13Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00383498922031-01-22Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00387478972031-08-11U-2724Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00387478972031-08-11U-2725Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00493932032026-04-27U-1877Drug product2016-07-22a50c72e98297…
2026-08-01 22:54:322026-06N203496-00474170702026-07-30Drug substance2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-004117238872028-12-15Drug substance2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06N203496-00484973932028-12-15Drug substance, Delist requested2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00495930662028-12-15Drug substance2017-03-14a50c72e98297…
2026-08-01 22:54:322026-06N203496-00484101692030-02-13Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00483498922031-01-22Drug product2014-01-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00487478972031-08-11U-2725Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00487478972031-08-11U-2724Drug product2014-06-13a50c72e98297…
2026-08-01 22:54:322026-06N203496-00593932032026-04-27U-1877Drug product2017-02-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-00574170702026-07-30Drug substance2017-02-09a50c72e98297…
2026-08-01 22:54:322026-06N203496-005117238872028-12-15Drug substance2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06N203496-00595930662028-12-15Drug substance2017-03-14a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N203496-001ODE-2722026-10-18a50c72e98297…
2026-08-01 22:54:322026-06N203496-002ODE-2722026-10-18a50c72e98297…
2026-08-01 22:54:322026-06N203496-003ODE-2722026-10-18a50c72e98297…
2026-08-01 22:54:322026-06N203496-004ODE-2722026-10-18a50c72e98297…
2026-08-01 22:54:322026-06N203496-005ODE-2722026-10-18a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrenitramTREPROSTINILUnited Therapeutics Corporation8ed2003a-c801-411e-831e-d06079bb0d7c2024-11-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 203496
application number: NDA203496
ndc (product): 66302-325
ndc (product): 66302-310
ndc (product): 66302-302
ndc (product): 66302-300
ndc (product): 66302-350

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84389SUPPL 2025-12-12
67028SUPPL2021-04-12
60618SUPPL2019-10-22
60597SUPPL2019-10-21
48753SUPPL2017-06-16
48715SUPPL2017-06-14
47005SUPPL2017-01-27
46981SUPPL2017-01-24
40306SUPPL2016-02-11
10227SUPPL2016-01-28
24436ORIG2014-12-09
22924ORIG2014-12-09
40305SUPPL2014-10-09
10226SUPPL2014-10-08
32433ORIG2013-12-24
19478ORIG2013-12-23