treprostinil · United Therap · NDA 021272, 208276
Remodulin
Earliest generic entry, as listed · earliest of 5 marketed strengths
29 Mar 2029
Blocked by patent: US 7999007.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7999007 | drug product, use U-1437 · sets the listed date | 29 Mar 2029 |
| US 11723887 | drug substance | 15 Dec 2028 |
| US 9593066 | drug substance | 15 Dec 2028 |
| US 8653137 | use U-1437 | 5 Sep 2028 |
| US 8658694 | use U-1437 | 5 Sep 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 · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021272 · 001 · RLD | injectable, intravenous, subcutaneous | 1MG/ML | 29 Mar 2029 |
| 021272 · 002 · RLD | injectable, intravenous, subcutaneous | 2.5MG/ML | 29 Mar 2029 |
| 021272 · 003 · RLD | injectable, intravenous, subcutaneous | 5MG/ML | 29 Mar 2029 |
| 021272 · 004 · RLD | injectable, intravenous, subcutaneous | 10MG/ML | 29 Mar 2029 |
| 021272 · 005 · RLD · discontinued | injectable, intravenous, subcutaneous | 20MG/ML | 29 Mar 2029 |
| 021272 · 006 · RLD · discontinued | injectable, intravenous, subcutaneous | 0.1MG/ML | 29 Mar 2029 |
| 021272 · 007 · RLD · discontinued | injectable, intravenous, subcutaneous | 0.2MG/ML | 29 Mar 2029 |
| 021272 · 008 · RLD | injectable, intravenous, subcutaneous | 0.4MG/ML | 29 Mar 2029 |
| 208276 · 001 · discontinued | solution, intravenous, subcutaneous | 20MG/20ML (1MG/ML) | 15 Dec 2028 |
| 208276 · 002 · discontinued | solution, intravenous, subcutaneous | 50MG/20ML (2.5MG/ML) | 15 Dec 2028 |
| 208276 · 003 · discontinued | solution, intravenous, subcutaneous | 100MG/20ML (5MG/ML) | 15 Dec 2028 |
| 208276 · 004 · discontinued | solution, intravenous, subcutaneous | 200MG/20ML (10MG/ML) | 15 Dec 2028 |