treprostinil · United Therap · NDA 214324
Tyvaso Dpi
Earliest generic entry, as listed · earliest of 5 marketed strengths
3 Feb 2042
Blocked by patent: US 11826327. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
8 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11826327 | use U-3749 · sets the listed date | 3 Feb 2042 |
| US 10421729 | drug product | 1 Apr 2035 |
| US 12679811 | use U-1849, U-3749 | 14 Mar 2034 |
| US 12679811 listing row | use U-1849 | 14 Mar 2034 |
| US 12679811 listing row | use U-3749 | 14 Mar 2034 |
| US 10772883 | drug product | 11 Jun 2030 |
| US 11723887 | drug substance | 15 Dec 2028 |
| US 9593066 | drug substance | 15 Dec 2028 |
| US 11357782 | use U-1849 | 14 May 2027 |
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 |
|---|---|---|---|
| 214324 · 001 · RLD | powder, inhalation | 0.016MG/INH | 3 Feb 2042 |
| 214324 · 002 · RLD | powder, inhalation | 0.032MG/INH | 3 Feb 2042 |
| 214324 · 003 · RLD | powder, inhalation | 0.048MG/INH | 3 Feb 2042 |
| 214324 · 004 · RLD | powder, inhalation | 0.064MG/INH | 3 Feb 2042 |
| 214324 · 005 · RLD | powder, inhalation | 0.08MG/INH | 3 Feb 2042 |