Treprostinil Extended Release Oral Tablet

Brand(s)
Orenitram
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
United Therapeutics Corporation (2014-10-14)
Oldest Current Product
2013-12-20
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\TREPROSTINIL
FDAOB
ORAL\TABLET, EXTENDED RELEASE\TREPROSTINIL DIOLAMINE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\TREPROSTINIL
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\TREPROSTINIL

product(s) by strength(s)

12 hr treprostinil 0.125 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663020300OrenitramNDAUnited Therapeutics Corporation2013-12-20TREPROSTINILORALTABLET, EXTENDED RELEASENDA2034968ed2003a-c801-411e-831e-d06079bb0d7c

12 hr treprostinil 0.25 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663020302OrenitramNDAUnited Therapeutics Corporation2013-12-20TREPROSTINILORALTABLET, EXTENDED RELEASENDA2034968ed2003a-c801-411e-831e-d06079bb0d7c

12 hr treprostinil 1 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663020310OrenitramNDAUnited Therapeutics Corporation2013-12-20TREPROSTINILORALTABLET, EXTENDED RELEASENDA2034968ed2003a-c801-411e-831e-d06079bb0d7c

12 hr treprostinil 2.5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663020325OrenitramNDAUnited Therapeutics Corporation2013-12-20TREPROSTINILORALTABLET, EXTENDED RELEASENDA2034968ed2003a-c801-411e-831e-d06079bb0d7c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203496ORENITRAMUNITED THERAPEUTICS CORP2013-12-20p8747897, SUBSTANCE
p8410169, SUBSTANCE
p6765117
p8252839, SUBSTANCE
p8497393
p9050311, SUBSTANCE
p7417070
p5153222, USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
p8349892, SUBSTANCE
p7544713, USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
NEW DOSAGE FORM [2016-12-20]NDA203496_001, NDA203496_002, NDA203496_003, NDA203496_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203496_001RXTREPROSTINIL DIOLAMINE (EQ 0.125MG BASE)ORALTABLET, EXTENDED RELEASEFalse2013-12-20ORENITRAM
2NDA203496_002RXTREPROSTINIL DIOLAMINE (EQ 0.25MG BASE)ORALTABLET, EXTENDED RELEASEFalse2013-12-20ORENITRAM
3NDA203496_003RXTREPROSTINIL DIOLAMINE (EQ 1MG BASE)ORALTABLET, EXTENDED RELEASEFalse2013-12-20ORENITRAM
4NDA203496_004RXTREPROSTINIL DIOLAMINE (EQ 2.5MG BASE)ORALTABLET, EXTENDED RELEASETrue2013-12-20ORENITRAM

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5153222 (view patent)2014-10-06NDA203496, NDA021272, NDA022387Treprostinil Injectable Solution
Treprostinil Inhalant Solution
2p6765117 (view patent)2017-10-24NDA203496, NDA021272, NDA022387Treprostinil Injectable Solution
Treprostinil Inhalant Solution
3p7417070 (view patent)2026-07-30NDA203496
4p7544713 (view patent)2024-07-14NDA203496
5p8252839 (view patent)2024-05-24NDA203496
6p8349892 (view patent)2031-01-22NDA203496
7p8410169 (view patent)2030-02-13NDA203496
8p8497393 (view patent)2028-12-15NDA203496, NDA021272, NDA022387Treprostinil Injectable Solution
Treprostinil Inhalant Solution
9p8747897 (view patent)2029-10-08NDA203496
10p9050311 (view patent)2024-05-24NDA203496

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18ed2003a-c801-411e-831e-d06079bb0d7c (view SPL)These highlights do not include all the information needed to use ORENITRAM safely and effectively. See Full Prescribing Information for ORENITRAM. ORENITRAM (treprostinil) extended-release tablets, for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionUnited Therapeutics CorporationANALYSIS, LABEL, MANUFACTURE, PACK2014-10-145663020300, 663020302, 663020310, 663020325

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII