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Remodulin, Trepulmix(treprostinil diolamine)
Orenitram, Remodulin, Trepulmix, Tyvaso (treprostinil diolamine) is a small molecule pharmaceutical. Treprostinil diolamine was first approved as Remodulin on 2002-05-21. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Orenitram, Remodulin, Tyvaso, Tyvaso dpi (generic drugs available since 2017-11-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Treprostinil
Tradename
Company
Number
Date
Products
REMODULINUnited TherapeuticsN-021272 RX2002-05-21
5 products, RLD, RS
TYVASOUnited TherapeuticsN-022387 RX2009-07-30
1 products, RLD, RS
TYVASO DPIUnited TherapeuticsN-214324 RX2022-05-23
4 products, RLD, RS
Show 1 discontinued
Treprostinil diolamine
Tradename
Company
Number
Date
Products
ORENITRAMUnited TherapeuticsN-203496 RX2013-12-20
5 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
diluent treprostinilANDA2023-04-06
orenitramNew Drug Application2020-11-01
remodulin sterile diluent for remodulinNew Drug Application2021-08-11
tyvasoNew Drug Application2022-09-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
Agency Specific
FDA
EMA
Expiration
Code
TREPROSTINIL DIOLAMINE, ORENITRAM, UNITED THERAP
2026-10-18ODE-272
TREPROSTINIL, TYVASO, UNITED THERAP
2024-03-31I-856
Patent Expiration
Patent
Expires
Flag
FDA Information
Treprostinil, Tyvaso Dpi, United Therap
104217292035-04-01DP
107728832030-06-11DP
101306852025-08-23DP
Treprostinil Diolamine, Orenitram, United Therap
87478972031-08-11DPU-2724, U-2725
83498922031-01-22DP
84101692030-02-13DP
84973932028-12-15DP
74170702026-07-30DP
93932032026-04-27DPU-1877
75447132024-07-14U-1475
82528392024-05-24DP
90503112024-05-24DS, DP
92789012024-05-24U-1475
94222232024-05-24DP
Treprostinil, Remodulin, United Therap
79990072029-03-29DPU-1437
95930662028-12-15DP
96049012028-12-15DP
86531372028-09-05U-1437
86586942028-09-05U-1437
97135992024-12-16U-2036
100765052024-12-16DP
106953082024-12-16U-2845
91999082024-05-24U-1771
Treprostinil, Tyvaso, United Therap
93582402028-05-05U-1849
93395072028-03-10DP
103765252027-05-14U-1849
107167932027-05-14U-1849
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AC: Platelet aggregation inhibitors excl. heparin
— B01AC21: Treprostinil
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10——17—8
Heart failureD006333EFO_0003144I50——11—2
Left ventricular dysfunctionD018487———1—1
Metabolic syndromeD024821EFO_0000195E88.81———1—1
ProteinuriaD011507HP_0000093R80———1—1
Coronary artery diseaseD003324I25.1———1—1
Aortic valve stenosisD001024EFO_0000266Q25.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTREPROSTINIL DIOLAMINE
INNtreprostinil
Description
Orenitram, Remodulin, Trepulmix, Tyvaso (treprostinil diolamine) is a small molecule pharmaceutical. Treprostinil diolamine was first approved as Remodulin on 2002-05-21. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension.
Classification
Small molecule
Drug classprostaglandins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCC[C@H](O)CC[C@@H]1[C@H]2Cc3cccc(OCC(=O)O)c3C[C@H]2C[C@H]1O.OCCNCCO
Identifiers
PDB—
CAS-ID830354-48-8
RxCUI—
ChEMBL IDCHEMBL2107815
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDRUM6K67ESG (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Orenitram - United Therapeutics
$
€
£
₣
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Tyvaso - United Therapeutics
$
€
£
₣
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Remodulin - United Therapeutics
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,091 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,017 adverse events reported
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