NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as UNITED THERAP. It is marketed under 1 brand name, including ORENITRAM. Available in 5 different strengths, such as EQ 0.125MG BASE, EQ 0.25MG BASE, EQ 1MG BASE and others, and administered through 1 route including TABLET, EXTENDED RELEASE;ORAL.
API availability: Loading API feasibility...
Licensing: 1 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"86976","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"e0a6905a106b4b169ee1","publication_number":"US9393203B2","cleaned_patent_number":"9393203","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-27","publication_date":"2016-07-19","legal_status":"Granted"} | US9393203B2 Formulation | 19 Jul, 2016 | Granted | 27 Apr, 2026 | |
| {"application_id":"62925","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"527227552b9a488c861d","publication_number":"US7417070B2","cleaned_patent_number":"7417070","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-30","publication_date":"2008-08-26","legal_status":"Granted"} | US7417070B2 Molecular | 26 Aug, 2008 | Granted | 30 Jul, 2026 | |
| {"application_id":"62962","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US9604901B2","cleaned_patent_number":"9604901","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2017-03-28","legal_status":"Patented case"} | US9604901B2 Molecular | 28 Mar, 2017 | Patented case | 15 Dec, 2028 | |
| {"application_id":"62975","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US8497393B2","cleaned_patent_number":"8497393","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2013-07-30","legal_status":"Granted"} | US8497393B2 Molecular | 30 Jul, 2013 | Granted | 15 Dec, 2028 | |
| {"application_id":"62978","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US9593066B2","cleaned_patent_number":"9593066","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2017-03-14","legal_status":"Granted"} | US9593066B2 Molecular | 14 Mar, 2017 | Granted | 15 Dec, 2028 | |
| {"application_id":"62982","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US11723887B2","cleaned_patent_number":"11723887","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2023-08-15","legal_status":"Granted"} | US11723887B2 Molecular | 15 Aug, 2023 | Granted | 15 Dec, 2028 | |
| {"application_id":"62929","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"527227552b9a488c861d","publication_number":"US8410169B2","cleaned_patent_number":"8410169","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-13","publication_date":"2013-04-02","legal_status":"Granted"} | US8410169B2 Formulation | 02 Apr, 2013 | Granted | 13 Feb, 2030 | |
| {"application_id":"86995","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"c1caa6ea226c4dcfb577","publication_number":"US8349892B2","cleaned_patent_number":"8349892","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-22","publication_date":"2013-01-08","legal_status":"Granted"} | US8349892B2 Formulation | 08 Jan, 2013 | Granted | 22 Jan, 2031 | |
| {"application_id":"86989","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"e0a6905a106b4b169ee1","publication_number":"US8747897B2","cleaned_patent_number":"8747897","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-11","publication_date":"2014-06-10","legal_status":"Granted"} | US8747897B2 Formulation | 10 Jun, 2014 | Granted | 11 Aug, 2031 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Treprostinil Diolamine
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.