tacrolimus · Veloxis Pharms Inc · NDA 206406
Envarsus Xr
Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Aug 2028
Blocked by patent: US 8664239, US 8664239, US 8664239, US 8685998, US 8685998, US 8685998.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8664239 | use U-2678 | 30 Aug 2028 |
| US 8664239 | use U-1752 | 30 Aug 2028 |
| US 8664239 | use U-2677 | 30 Aug 2028 |
| US 8685998 | product, use U-2677 | 30 Aug 2028 |
| US 8685998 | product, use U-2678 | 30 Aug 2028 |
| US 8685998 | product, use U-1752 | 30 Aug 2028 |
| US 10166190 | product | 30 May 2028 |
| US 10864199 | use U-2678 | 30 May 2028 |
| US 10864199 | use U-2677 | 30 May 2028 |
| US 11110081 | use U-2678 | 30 May 2028 |
| US 11123331 | use U-2677 | 30 May 2028 |
| US 11419823 | product | 30 May 2028 |
| US 12083103 | use U-2678 | 30 May 2028 |
| US 12403095 | product | 30 May 2028 |
| US 9549918 | product | 30 May 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206406 · 001 · RLD | tablet, extended release, oral | EQ 0.75MG BASE | 30 Aug 2028 |
| 206406 · 002 · RLD | tablet, extended release, oral | EQ 1MG BASE | 30 Aug 2028 |
| 206406 · 003 · RLD | tablet, extended release, oral | EQ 4MG BASE | 30 Aug 2028 |