ponesimod · Vanda Pharms Inc · NDA 213498
Ponvory
Earliest generic entry, as listed · earliest of 2 marketed strengths
24 Dec 2044
Blocked by patent: US 12728116. 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 12728116 | use U-4610 | 24 Dec 2044 |
| US 11951097 | use U-3891 | 10 Oct 2042 |
| US 10220023 | use U-3103 | 10 Dec 2035 |
| US 12336980 | use U-3103 | 10 Dec 2035 |
| US 9062014 | substance, product, use U-2774 | 6 May 2032 |
| US RE43728 | substance, product | 16 Nov 2029 |
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 |
|---|---|---|---|
| 213498 · 001 · RLD | tablet, oral | 2MG; 3MG; 4MG; 5MG; 6MG; 7MG; 8MG; 9MG; 10MG | 24 Dec 2044 |
| 213498 · 010 · RLD | tablet, oral | 20MG | 24 Dec 2044 |
Expired or delisted (1)
- NCE · 18 Mar 2026