treprostinil diolamine · United Therap · NDA 203496
Orenitram
Earliest generic entry, as listed · earliest of 5 marketed strengths
11 Aug 2031
Blocked by patent: US 8747897, US 8747897.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8747897 | product, use U-2725 | 11 Aug 2031 |
| US 8747897 | product, use U-2724 | 11 Aug 2031 |
| US 8349892 | product | 22 Jan 2031 |
| US 8410169 | product | 13 Feb 2030 |
| US 11723887 | substance | 15 Dec 2028 |
| US 9593066 | substance | 15 Dec 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203496 · 001 · RLD | tablet, extended release, oral | EQ 0.125MG BASE | 11 Aug 2031 |
| 203496 · 002 · RLD | tablet, extended release, oral | EQ 0.25MG BASE | 11 Aug 2031 |
| 203496 · 003 · RLD | tablet, extended release, oral | EQ 1MG BASE | 11 Aug 2031 |
| 203496 · 004 · RLD | tablet, extended release, oral | EQ 2.5MG BASE | 11 Aug 2031 |
| 203496 · 005 · RLD | tablet, extended release, oral | EQ 5MG BASE | 11 Aug 2031 |
Expired or delisted (5)
- US 8497393 · substance · 15 Dec 2028 · delisted
- US 9604901 · substance · 15 Dec 2028 · delisted
- US 7417070 · substance · 30 Jul 2026
- US 9393203 · product, use U-1877 · 27 Apr 2026
- ODE-272 · 18 Oct 2026