lumasiran sodium · Alnylam Pharms Inc · NDA 214103
Oxlumo
Earliest generic entry, as listed
29 May 2041
Blocked by patent: US 12723247.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12723247 | drug substance, drug product, use U-2995 · sets the listed date | 29 May 2041 |
| US 11261447 | drug substance, drug product, use U-2995 | 20 Nov 2038 |
| US 10478500 | drug substance, drug product, use U-2995 | 9 Oct 2035 |
| US 11446380 | drug substance, drug product | 9 Oct 2035 |
| US 10612024 | drug substance, drug product, use U-2995 | 14 Aug 2035 |
| US 10612027 | drug substance, drug product, use U-2995 | 14 Aug 2035 |
| US 11401517 | drug substance, drug product, use U-2995 | 14 Aug 2035 |
| US 10435692 | use U-2995 | 26 Dec 2034 |
| US 10465195 | drug substance, drug product, use U-2995 | 26 Dec 2034 |
| US 10487330 | drug substance, drug product, use U-2995 | 26 Dec 2034 |
| US 11060093 | drug substance, drug product, use U-2995 | 26 Dec 2034 |
| US 9828606 | drug substance, drug product | 26 Dec 2034 |
| US 8106022 | drug substance, drug product, use U-2995 | 12 Dec 2029 |
| US 8828956 | drug substance, drug product, use U-2995 | 4 Dec 2028 |
| US 10131907 | drug substance, drug product, use U-2995 | 24 Aug 2028 |
Exclusivities · 2 unexpired
| ODE-415 | orphan drug (7 years) | 6 Oct 2029 |
| ODE-339 | orphan drug (7 years) | 23 Nov 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
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 |
|---|---|---|---|
| 214103 · 001 · RLD | solution, subcutaneous | EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | 29 May 2041 |