brincidofovir · Emergent Biodefense · NDA 214460, 214461
Tembexa
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Jul 2034
Other strengths are listed to 10 Oct 2034.
Blocked by patent: US 9303051.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10112909 | use U-3165 | 10 Oct 2034 |
| US 10487061 | product, use U-3165 | 10 Oct 2034 |
| US 8962829 | substance, product | 10 Oct 2034 |
| US 9371344 | product | 10 Oct 2034 |
| US 9303051 | substance, product, use U-3165 | 30 Jul 2034 |
Exclusivities · 1 unexpired
| ODE-354 | orphan drug (7 years) | 4 Jun 2028 |
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 |
|---|---|---|---|
| 214460 · 001 · RLD | suspension, oral | 10MG/ML | 30 Jul 2034 |
| 214461 · 001 · RLD | tablet, oral | 100MG | 10 Oct 2034 |