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 | 2023-11-07 |
| remodulin | New Drug Application | 2014-12-31 |
| remodulin sterile diluent for remodulin | New Drug Application | 2023-10-09 |
| sterile diluent for treprostinil treprostinil | ANDA | 2021-12-23 |
| treprostinil | ANDA | 2023-01-25 |
| tyvaso | New Drug Application | 2024-09-11 |
| tyvaso dpi | New Drug Application | 2024-08-13 |
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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 5 | 22 | 30 | 19 | 20 | 92 |
| Pulmonary arterial hypertension | D000081029 | — | — | 10 | 11 | 20 | 18 | 15 | 73 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 3 | 14 | 19 | 7 | 9 | 49 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | 8 | 15 | 12 | 10 | 45 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 9 | 10 | 1 | 4 | 21 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 1 | 1 | — | 2 |
| Ventricular remodeling | D020257 | — | — | — | — | — | 1 | — | 1 |
| Lung transplantation | D016040 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | 7 | 7 | — | 3 | 14 |
| Pulmonary fibrosis | D011658 | — | — | — | 5 | 6 | — | 1 | 10 |
| Fibrosis | D005355 | — | — | — | 3 | 4 | — | — | 7 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 2 | 2 | — | 1 | 6 |
| Ischemia | D007511 | EFO_0000556 | — | 2 | 4 | 2 | — | — | 6 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | 2 | 2 | — | 1 | 5 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 2 | 3 | — | — | 5 |
| Chronic limb-threatening ischemia | D000089802 | — | — | — | 3 | 2 | — | — | 4 |
| Foot ulcer | D016523 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | 2 | 2 | — | 1 | 3 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | 1 | — | — | — | 7 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 3 | 5 | — | — | — | 6 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 3 | 5 | — | — | — | 6 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | 1 | — | — | — | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | — | — | 1 | 3 |
| Sclerosis | D012598 | — | — | 1 | 2 | — | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 2 | 1 | — | — | — | 2 |
| Reperfusion injury | D015427 | — | — | 2 | 1 | — | — | — | 2 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | 1 | — | — | 1 | 2 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 1 | — | — | 1 | 2 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Univentricular heart | D000080039 | — | Q20.4 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Dialysis | D003956 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | — | — | — | 1 | 1 |
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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Remodulin – United Therapeutics
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Orenitram – United Therapeutics
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Tyvaso – United Therapeutics
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Estimated US medical usage
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Trends
PubMed Central
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Safety
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No Black-box warning
Adverse Events
Top Adverse Reactions
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84,692 adverse events reported
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