inclisiran sodium · Novartis · NDA 214012
Leqvio
Earliest generic entry, as listed
25 Aug 2036
Blocked by patent: US 10851377. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
26 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10851377 | use U-4249, U-4413, U-4414 | 25 Aug 2036 |
| US 10851377 listing row | use U-4249 · sets the listed date | 25 Aug 2036 |
| US 10851377 listing row | use U-4413 · sets the listed date | 25 Aug 2036 |
| US 10851377 listing row | use U-4414 · sets the listed date | 25 Aug 2036 |
| US 10125369 | drug substance, drug product, use U-4249, U-4413, U-4414 | 18 Aug 2034 |
| US 10125369 listing row | drug substance, drug product, use U-4249 | 18 Aug 2034 |
| US 10125369 listing row | drug substance, drug product, use U-4413 | 18 Aug 2034 |
| US 10125369 listing row | drug substance, drug product, use U-4414 | 18 Aug 2034 |
| US 12460206 | drug substance, drug product | 18 Aug 2034 |
| US 8106022 | drug substance, drug product, use U-4249, U-4413, U-4414 | 12 Dec 2029 |
| US 8106022 listing row | drug substance, drug product, use U-4249 | 12 Dec 2029 |
| US 8106022 listing row | drug substance, drug product, use U-4413 | 12 Dec 2029 |
| US 8106022 listing row | drug substance, drug product, use U-4414 | 12 Dec 2029 |
| US 10806791 | drug substance | 4 Dec 2028 |
| US 8828956 | drug substance, drug product, use U-4249, U-4413, U-4414 | 4 Dec 2028 |
| US 8828956 listing row | drug substance, drug product, use U-4249 | 4 Dec 2028 |
| US 8828956 listing row | drug substance, drug product, use U-4413 | 4 Dec 2028 |
| US 8828956 listing row | drug substance, drug product, use U-4414 | 4 Dec 2028 |
| US 9370582 | drug substance, drug product, use U-4249, U-4413, U-4414 | 4 Dec 2028 |
| US 9370582 listing row | drug substance, drug product, use U-4249 | 4 Dec 2028 |
| US 9370582 listing row | drug substance, drug product, use U-4413 | 4 Dec 2028 |
| US 9370582 listing row | drug substance, drug product, use U-4414 | 4 Dec 2028 |
| US 10131907 | drug substance, drug product, use U-4249, U-4413, U-4414 | 24 Aug 2028 |
| US 10131907 listing row | drug substance, drug product, use U-4249 | 24 Aug 2028 |
| US 10131907 listing row | drug substance, drug product, use U-4413 | 24 Aug 2028 |
| US 10131907 listing row | drug substance, drug product, use U-4414 | 24 Aug 2028 |
| US 8222222 | use U-4249, U-4413, U-4414 | 29 Dec 2027 |
| US 8222222 listing row | use U-4249 | 29 Dec 2027 |
| US 8222222 listing row | use U-4413 | 29 Dec 2027 |
| US 8222222 listing row | use U-4414 | 29 Dec 2027 |
| US 8809292 | drug substance, drug product, use U-4249, U-4413, U-4414 | 10 May 2027 |
| US 8809292 listing row | drug substance, drug product, use U-4249 | 10 May 2027 |
| US 8809292 listing row | drug substance, drug product, use U-4413 | 10 May 2027 |
| US 8809292 listing row | drug substance, drug product, use U-4414 | 10 May 2027 |
Exclusivities · 4 unexpired
| ODE-555 | orphan drug (7 years) | 12 Feb 2033 |
| I-985 | new indication (3 years) | 12 Feb 2029 |
| NPP | new patient population | 12 Feb 2029 |
| NCE | new chemical entity (5 years) | 22 Dec 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 NCE · 214012-001Exclusivity expires 22 Dec 2026Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214012 · 001 · RLD | solution, subcutaneous | EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) | 25 Aug 2036 |