foscarbidopa; foslevodopa · Abbvie · NDA 216962
Vyalev
Earliest generic entry, as listed
10 Jun 2040
Blocked by patent: US 12251365. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12251365 | use U-4030 | 10 Jun 2040 |
| US 10174061 | product, use U-4030 | 21 Oct 2035 |
| US 10730895 | substance | 21 Oct 2035 |
| US 9446059 | substance, product, use U-4030 | 21 Oct 2035 |
Exclusivities · 1 unexpired
| NP | new product | 16 Oct 2027 |
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 |
|---|---|---|---|
| 216962 · 001 · RLD | solution, subcutaneous | 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) | 10 Jun 2040 |