fitusiran sodium · Genzyme Corp · NDA 219019
Qfitlia
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Dec 2036
Blocked by patent: US 11091759. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11091759 | use U-4165 | 7 Dec 2036 |
| US 9127274 | substance, product, use U-4165 | 22 Mar 2033 |
| US RE50996 | substance, product, use U-4165 | 22 Mar 2033 |
| US 9376680 | substance, product, use U-4165 | 15 Mar 2033 |
Exclusivities · 3 unexpired
| ODE-510 | orphan drug (7 years) | 28 Mar 2032 |
| ODE-511 | orphan drug (7 years) | 28 Mar 2032 |
| NCE | new chemical entity (5 years) | 28 Mar 2030 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219019 · 001 · RLD | solution, subcutaneous | EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) | 7 Dec 2036 |
| 219019 · 002 · RLD | solution, subcutaneous | EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) | 7 Dec 2036 |