tacrolimus · Astellas · NDA 050708, 050709, 210115
Prograf
Earliest generic entry, as listed · earliest of 6 marketed strengths
16 Jul 2028
Blocked by exclusivity: ODE-360.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-360 | orphan drug (7 years) | 16 Jul 2028 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050708 · 001 · RLD | capsule, oral | EQ 1MG BASE | 16 Jul 2028 |
| 050708 · 002 · RLD | capsule, oral | EQ 5MG BASE | 16 Jul 2028 |
| 050708 · 003 · RLD | capsule, oral | EQ 0.5MG BASE | 16 Jul 2028 |
| 050709 · 001 · RLD | injectable, injection | EQ 5MG BASE/ML | 16 Jul 2028 |
| 210115 · 001 · RLD | for suspension, oral | EQ 0.2MG BASE/PACKET | 16 Jul 2028 |
| 210115 · 002 · RLD | for suspension, oral | EQ 1MG BASE/PACKET | 16 Jul 2028 |