treprostinil · United Therap · NDA 022387
Tyvaso
Earliest generic entry, as listed
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 · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11826327 | use U-3749 | 3 Feb 2042 |
| US 11723887 | substance | 15 Dec 2028 |
| US 9593066 | substance | 15 Dec 2028 |
| US 9358240 | use U-1849 | 5 May 2028 |
| US 9339507 | product | 10 Mar 2028 |
| US 10376525 | 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022387 · 001 · RLD | solution, inhalation | 0.6MG/ML | 3 Feb 2042 |