everolimus · Novartis Pharm · NDA 203985
Afinitor Disperz
Earliest generic entry, as listed · earliest of 3 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 217216, Biocon Pharma · 203985-001Approved 9 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220597, Novitium Pharma · 203985-001Approved 21 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203985 · 001 · RLD | tablet, for suspension, oral | 2MG | open |
| 203985 · 002 · RLD | tablet, for suspension, oral | 3MG | open |
| 203985 · 003 · RLD | tablet, for suspension, oral | 5MG | open |