cyclosporine · Novartis · NDA 050573, 050574, 050625
Sandimmune
Earliest generic entry, as listed · earliest of 5 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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
- Generic approved · ANDA 219652, Aurobindo Pharma Ltd · 050625-001Approved 17 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050573 · 001 · RLD | injectable, injection | 50MG/ML | open |
| 050574 · 001 · RLD | solution, oral | 100MG/ML | open |
| 050625 · 001 · RLD | capsule, oral | 25MG | open |
| 050625 · 002 · RLD | capsule, oral | 100MG | open |
| 050625 · 003 · RLD | capsule, oral | 50MG | open |