tafamidis · Foldrx Pharms · NDA 212161
Vyndamax
Earliest generic entry, as listed
31 Aug 2035
Blocked by patent: US 9770441.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9770441 | drug substance, drug product, use U-2524 · sets the listed date | 31 Aug 2035 |
| US 7214695 | drug substance, drug product | 19 Dec 2026 |
| US 7214696 | use U-2524 | 19 Dec 2026 |
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 |
|---|---|---|---|
| 212161 · 001 · RLD | capsule, oral | 61MG | 31 Aug 2035 |
Expired or delisted (1)
- ODE-237 · 3 May 2026