Orange Book product · Brand (NDA)
NEXLIZET
BEMPEDOIC ACID; EZETIMIBE
At a glance
Feb 26, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2020
6 yr 5 mo ago
Today
Exclusivity ends · I-943
New indication exclusivity (3 years)
Mar 22, 2027
in 9 mo
Exclusivity ends · I-945
New indication exclusivity (3 years)
Mar 22, 2027
in 9 mo
Patent 7335799 expires
Listed drug substance patent expiration.
Dec 03, 2030
in 4 yr 6 mo
Patent 10912751 expires
Listed method-of-use patent (U-3884) expiration.
Mar 14, 2036
in 9 yr 11 mo
Patent 10912751 expires
Listed method-of-use patent (U-3224) expiration.
Mar 14, 2036
in 9 yr 11 mo
Patent 11744816 expires
Listed method-of-use patent (U-3883) expiration.
Mar 14, 2036
in 9 yr 11 mo
Patent 11744816 expires
Listed method-of-use patent (U-3692) expiration.
Mar 14, 2036
in 9 yr 11 mo
Patent 11613511 expires
Listed drug substance patent expiration.
Jun 19, 2040
in 14 yr 2 mo
Patent 11760714 expires
Listed drug product patent expiration.
Jun 19, 2040
in 14 yr 2 mo
Patent 11926584 expires
Listed method-of-use patent (U-3873) expiration.
Jun 19, 2040
in 14 yr 2 mo
Patent 12398087 expires
Listed drug substance patent expiration.
Jun 19, 2040
in 14 yr 2 mo
Patent 12404227 expires
Listed drug substance patent expiration.
Jun 19, 2040
in 14 yr 2 mo
Pharmaceutical detail
Active ingredient
BEMPEDOIC ACID; EZETIMIBE
Strength
180MG;10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211617
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 (2)
- I-943New indication exclusivity (3 years)
Mar 22, 2027
in 9 mo
- I-945New indication exclusivity (3 years)
Mar 22, 2027
in 9 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7335799 | Dec 03, 2030 | in 4 yr 6 mo | Substance |
| 10912751 | Mar 14, 2036 | in 9 yr 11 mo | U-3884 |
| 10912751 | Mar 14, 2036 | in 9 yr 11 mo | U-3224 |
| 11744816 | Mar 14, 2036 | in 9 yr 11 mo | U-3883 |
| 11744816 | Mar 14, 2036 | in 9 yr 11 mo | U-3692 |
| 11613511 | Jun 19, 2040 | in 14 yr 2 mo | Substance |
| 11760714 | Jun 19, 2040 | in 14 yr 2 mo | Product |
| 11926584 | Jun 19, 2040 | in 14 yr 2 mo | U-3873 |
| 12398087 | Jun 19, 2040 | in 14 yr 2 mo | SubstanceProduct |
| 12404227 | Jun 19, 2040 | in 14 yr 2 mo | SubstanceU-4258 |

