Treprostinil diolamine
Orenitram, Remodulin, Treprostinil, 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 diseases | D012140 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Orenitram
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Treprostinil diolamine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORENITRAM | United Therapeutics | N-203496 RX | 2013-12-20 | 5 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diluent treprostinil | ANDA | 2023-04-06 |
| orenitram | New Drug Application | 2024-11-20 |
| remodulin | New Drug Application | 2014-12-31 |
| remodulin sterile diluent for remodulin | New Drug Application | 2024-12-10 |
| sterile diluent for treprostinil treprostinil | ANDA | 2021-12-23 |
| treprostinil | ANDA | 2023-01-25 |
| tyvaso | New Drug Application | 2024-12-13 |
| tyvaso dpi | New Drug Application | 2024-12-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TREPROSTINIL DIOLAMINE, ORENITRAM, UNITED THERAP | |||
| 2026-10-18 | ODE-272 | ||
TREPROSTINIL, TYVASO, UNITED THERAP | |||
| 2024-03-31 | I-856 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Treprostinil, Tyvaso, United Therap | |||
| 11826327 | 2042-01-04 | U-3749 | |
| 9358240 | 2028-05-05 | U-1849 | |
| 9339507 | 2028-03-10 | DP | |
| 10376525 | 2027-05-14 | U-1849 | |
| 10716793 | 2027-05-14 | U-1849 | |
| Treprostinil, Tyvaso Dpi, United Therap | |||
| 10421729 | 2035-04-01 | DP | |
| 10772883 | 2030-06-11 | DP | |
| 10130685 | 2025-08-23 | DP | |
| Treprostinil Diolamine, Orenitram, United Therap | |||
| 8747897 | 2031-08-11 | DP | U-2724, U-2725 |
| 8349892 | 2031-01-22 | DP | |
| 8410169 | 2030-02-13 | DP | |
| 8497393 | 2028-12-15 | DP | |
| 7417070 | 2026-07-30 | DP | |
| 9393203 | 2026-04-27 | DP | U-1877 |
| 7544713 | 2024-07-14 | U-1475 | |
| 8252839 | 2024-05-24 | DP | |
| 9050311 | 2024-05-24 | DS, DP | |
| 9278901 | 2024-05-24 | U-1475 | |
| 9422223 | 2024-05-24 | DP | |
| Treprostinil, Remodulin, United Therap | |||
| 7999007 | 2029-03-29 | DP | U-1437 |
| 9593066 | 2028-12-15 | DP | |
| 9604901 | 2028-12-15 | DP | |
| 11723887 | 2028-12-15 | DP | |
| 8653137 | 2028-09-05 | U-1437 | |
| 8658694 | 2028-09-05 | U-1437 | |
| 9713599 | 2024-12-16 | U-2036 | |
| 10076505 | 2024-12-16 | DP | |
| 10695308 | 2024-12-16 | U-2845 | |
| 9199908 | 2024-05-24 | U-1771 | |
HCPCS
No data
Clinical
Clinical Trials
137 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 1 | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Treprostinil diolamine |
| INN | treprostinil |
| 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 class | prostaglandins |
| 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-ID | 830354-48-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107815 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | RUM6K67ESG (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Tyvaso – United Therapeutics
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Orenitram – United Therapeutics
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Remodulin – United Therapeutics
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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89,620 adverse events reported
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