voclosporin · Aurinia · NDA 213716
Lupkynis
Earliest generic entry, as listed
7 Dec 2037
Blocked by patent: US 10286036, US 11622991. 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 10286036 | use U-3056 | 7 Dec 2037 |
| US 11622991 | use U-3056 | 7 Dec 2037 |
| US 7332472 | substance, product, use U-3056 | 17 Oct 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213716 · 001 · RLD | capsule, oral | 7.9MG | 7 Dec 2037 |
Expired or delisted (1)
- NCE · 22 Jan 2026