ambrisentan · Gilead · NDA 022081
Letairis
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Oct 2031
Blocked by patent: US 9549926. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9549926 | use U-1965 | 14 Oct 2031 |
| US 8377933 | use U-1754 | 11 Dec 2027 |
| US 9474752 | use U-1754 | 11 Dec 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022081 · 001 · RLD | tablet, oral | 5MG | 14 Oct 2031 |
| 022081 · 002 · RLD | tablet, oral | 10MG | 14 Oct 2031 |