mycophenolate mofetil · Roche Palo · NDA 050722, 050723, 050758, 050759
Cellcept
Earliest generic entry, as listed · earliest of 4 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 218566, Neocubes Pharma · 050759-001Approved 1 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050722 · 001 · RLD | capsule, oral | 250MG | open |
| 050723 · 001 · RLD | tablet, oral | 500MG | open |
| 050758 · 001 · RLD | injectable, injection | 500MG/VIAL | open |
| 050759 · 001 · RLD | for suspension, oral | 200MG/ML | open |