givosiran sodium · Alnylam Pharms Inc · NDA 212194
Givlaari
Earliest generic entry, as listed
3 Oct 2034
Blocked by patent: US 10119143, US 11028392.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10119143 | drug substance, drug product, use U-2672 · sets the listed date | 3 Oct 2034 |
| US 11028392 | drug substance, drug product, use U-2672 · sets the listed date | 3 Oct 2034 |
| US 9133461 | drug substance, drug product, use U-2672 | 30 Nov 2033 |
| US 10125364 | drug substance, drug product, use U-2672 | 15 Mar 2033 |
| US 9631193 | use U-2672 | 15 Mar 2033 |
| US 8106022 | drug substance, drug product, use U-2672 | 12 Dec 2029 |
| US 8828956 | drug substance, drug product, use U-2672 | 4 Dec 2028 |
| US 10131907 | drug substance, drug product, use U-2672 | 24 Aug 2028 |
Exclusivities · 1 unexpired
| ODE-273 | orphan drug (7 years) | 20 Nov 2026 |
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 ODE-273 · 212194-001Exclusivity expires 20 Nov 2026Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212194 · 001 · RLD | solution, subcutaneous | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | 3 Oct 2034 |