alpelisib · Novartis · NDA 212526
Piqray
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Apr 2033
Blocked by patent: US 8227462.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8227462 | drug substance, drug product, use U-3809 · sets the listed date | 29 Apr 2033 |
| US 8476268 | drug substance, drug product | 10 Sep 2029 |
Exclusivities · 1 unexpired
| I-937 | new indication (3 years) | 18 Jan 2027 |
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
- Exclusivity expires within 90 days I-937 · 212526-003Exclusivity expires 18 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days I-937 · 212526-002Exclusivity expires 18 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days I-937 · 212526-001Exclusivity expires 18 Jan 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212526 · 001 · RLD | tablet, oral | 50MG | 29 Apr 2033 |
| 212526 · 002 · RLD | tablet, oral | 150MG | 29 Apr 2033 |
| 212526 · 003 · RLD | tablet, oral | 200MG | 29 Apr 2033 |