patisiran sodium · Alnylam Pharms Inc · NDA 210922
Onpattro
Earliest generic entry, as listed
27 Aug 2035
Blocked by patent: US 11079379.
Listed patents · 13 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11079379 | drug substance, drug product, use U-2378 · sets the listed date | 27 Aug 2035 |
| US 8168775 | drug substance, drug product, use U-2378 | 10 Aug 2032 |
| US 8158601 | drug product, use U-2378 | 10 Nov 2030 |
| US 8802644 | drug product, use U-2378 | 21 Oct 2030 |
| US 10240152 | drug substance, drug product, use U-2378 | 20 Oct 2029 |
| US 8741866 | use U-2378 | 20 Oct 2029 |
| US 9234196 | drug product, use U-2378 | 20 Oct 2029 |
| US 11141378 | drug product | 15 Apr 2029 |
| US 8058069 | drug product | 15 Apr 2029 |
| US 8492359 | drug product | 15 Apr 2029 |
| US 8822668 | drug product, use U-2378 | 15 Apr 2029 |
| US 9364435 | drug product, use U-2378 | 15 Apr 2029 |
| US 8642076 | drug product | 3 Oct 2027 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210922 · 001 · RLD | solution, intravenous | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | 27 Aug 2035 |
Expired or delisted (1)
- M-270 · 13 Jan 2026