Orange Book product · Brand (NDA)
LEQVIO
INCLISIRAN SODIUM
At a glance
Dec 22, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
26
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2021
4 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 22, 2026
in 6 mo
Patent 8809292 expires
Listed drug substance patent expiration.
May 10, 2027
in 11 mo
Patent 8809292 expires
Listed drug substance patent expiration.
May 10, 2027
in 11 mo
Patent 8809292 expires
Listed drug substance patent expiration.
May 10, 2027
in 11 mo
Patent 8222222 expires
Listed method-of-use patent (U-4249) expiration.
Dec 29, 2027
in 1 yr 7 mo
Patent 8222222 expires
Listed method-of-use patent (U-4413) expiration.
Dec 29, 2027
in 1 yr 7 mo
Patent 8222222 expires
Listed method-of-use patent (U-4414) expiration.
Dec 29, 2027
in 1 yr 7 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 10806791 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 9370582 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 9370582 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Patent 9370582 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Exclusivity ends · I-985
New indication exclusivity (3 years)
Feb 12, 2029
in 2 yr 8 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Feb 12, 2029
in 2 yr 8 mo
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Patent 10125369 expires
Listed drug substance patent expiration.
Aug 18, 2034
in 8 yr 3 mo
Patent 10125369 expires
Listed drug substance patent expiration.
Aug 18, 2034
in 8 yr 3 mo
Patent 10125369 expires
Listed drug substance patent expiration.
Aug 18, 2034
in 8 yr 3 mo
Patent 12460206 expires
Listed drug substance patent expiration.
Aug 18, 2034
in 8 yr 3 mo
Patent 10851377 expires
Listed method-of-use patent (U-4413) expiration.
Aug 25, 2036
in 10 yr 4 mo
Patent 10851377 expires
Listed method-of-use patent (U-4414) expiration.
Aug 25, 2036
in 10 yr 4 mo
Patent 10851377 expires
Listed method-of-use patent (U-4249) expiration.
Aug 25, 2036
in 10 yr 4 mo
Pharmaceutical detail
Active ingredient
INCLISIRAN SODIUM
Strength
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 214012
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2026
in 6 mo
- I-985New indication exclusivity (3 years)
Feb 12, 2029
in 2 yr 8 mo
- NPPNew patient population exclusivity (3 years)
Feb 12, 2029
in 2 yr 8 mo
Listed patents (26)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8809292 | May 10, 2027 | in 11 mo | SubstanceProductU-4413 |
| 8809292 | May 10, 2027 | in 11 mo | SubstanceProductU-4414 |
| 8809292 | May 10, 2027 | in 11 mo | SubstanceProductU-4249 |
| 8222222 | Dec 29, 2027 | in 1 yr 7 mo | U-4249 |
| 8222222 | Dec 29, 2027 | in 1 yr 7 mo | U-4413 |
| 8222222 | Dec 29, 2027 | in 1 yr 7 mo | U-4414 |
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-4413 |
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-4249 |
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-4414 |
| 10806791 | Dec 04, 2028 | in 2 yr 6 mo | Substance |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4413 |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4414 |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4249 |
| 9370582 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4413 |
| 9370582 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4414 |
| 9370582 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-4249 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-4249 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-4413 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-4414 |
| 10125369 | Aug 18, 2034 | in 8 yr 3 mo | SubstanceProductU-4413 |
| 10125369 | Aug 18, 2034 | in 8 yr 3 mo | SubstanceProductU-4414 |
| 10125369 | Aug 18, 2034 | in 8 yr 3 mo | SubstanceProductU-4249 |
| 12460206 | Aug 18, 2034 | in 8 yr 3 mo | SubstanceProduct |
| 10851377 | Aug 25, 2036 | in 10 yr 4 mo | U-4413 |
| 10851377 | Aug 25, 2036 | in 10 yr 4 mo | U-4414 |
| 10851377 | Aug 25, 2036 | in 10 yr 4 mo | U-4249 |
