pasireotide diaspartate · Recordati Rare · NDA 200677
Signifor
Earliest generic entry, as listed · earliest of 3 marketed strengths
14 Dec 2026
Blocked by patent: US 7473761.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7473761 | drug substance, drug product · sets the listed date | 14 Dec 2026 |
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
- Enters 12-month window basis: patent · 200677-003Listed date 14 Dec 2026Detected 24 Oct 2026
- Enters 12-month window basis: patent · 200677-002Listed date 14 Dec 2026Detected 24 Oct 2026
- Enters 12-month window basis: patent · 200677-001Listed date 14 Dec 2026Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200677 · 001 · RLD | solution, subcutaneous | EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) | 14 Dec 2026 |
| 200677 · 002 · RLD | solution, subcutaneous | EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) | 14 Dec 2026 |
| 200677 · 003 · RLD | solution, subcutaneous | EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) | 14 Dec 2026 |