Orange Book product · Brand (NDA)
LYBALVI
OLANZAPINE; SAMIDORPHAN L-MALATE
At a glance
May 28, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
21
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2021
5 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
Today
Patent 10716785 expires
Listed method-of-use patent (U-3136) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 10716785 expires
Listed method-of-use patent (U-3137) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 11185541 expires
Listed method-of-use patent (U-3140) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 11241425 expires
Listed method-of-use patent (U-3137) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 11351166 expires
Listed method-of-use patent (U-3140) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 11351166 expires
Listed method-of-use patent (U-3141) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 11793805 expires
Listed method-of-use patent (U-3734) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 12194035 expires
Listed method-of-use patent (U-3141) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 9126977 expires
Listed drug product patent expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 9126977 expires
Listed drug product patent expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 9517235 expires
Listed method-of-use patent (U-3139) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 9517235 expires
Listed method-of-use patent (U-3138) expiration.
Aug 23, 2031
in 5 yr 3 mo
Patent 9119848 expires
Listed drug substance patent expiration.
Aug 30, 2031
in 5 yr 3 mo
Patent 8778960 expires
Listed method-of-use patent (U-3136) expiration.
Feb 13, 2032
in 5 yr 9 mo
Patent 8778960 expires
Listed method-of-use patent (U-3137) expiration.
Feb 13, 2032
in 5 yr 9 mo
Patent 10300054 expires
Listed drug product patent expiration.
May 31, 2033
in 7 yr 1 mo
Patent 10300054 expires
Listed drug product patent expiration.
May 31, 2033
in 7 yr 1 mo
Patent 11707466 expires
Listed drug product patent expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 11951111 expires
Listed method-of-use patent (U-3886) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 11951111 expires
Listed method-of-use patent (U-3887) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12390474 expires
Listed drug product patent expiration.
Nov 12, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
OLANZAPINE; SAMIDORPHAN L-MALATE
Strength
5MG;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213378
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 (1)
- NCENew chemical entity exclusivity (5 years)
May 28, 2026
22 d ago
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10716785 | Aug 23, 2031 | in 5 yr 3 mo | U-3136 |
| 10716785 | Aug 23, 2031 | in 5 yr 3 mo | U-3137 |
| 11185541 | Aug 23, 2031 | in 5 yr 3 mo | U-3140 |
| 11241425 | Aug 23, 2031 | in 5 yr 3 mo | U-3137 |
| 11351166 | Aug 23, 2031 | in 5 yr 3 mo | U-3140 |
| 11351166 | Aug 23, 2031 | in 5 yr 3 mo | U-3141 |
| 11793805 | Aug 23, 2031 | in 5 yr 3 mo | U-3734 |
| 12194035 | Aug 23, 2031 | in 5 yr 3 mo | U-3141 |
| 9126977 | Aug 23, 2031 | in 5 yr 3 mo | ProductU-3136 |
| 9126977 | Aug 23, 2031 | in 5 yr 3 mo | ProductU-3137 |
| 9517235 | Aug 23, 2031 | in 5 yr 3 mo | U-3139 |
| 9517235 | Aug 23, 2031 | in 5 yr 3 mo | U-3138 |
| 9119848 | Aug 30, 2031 | in 5 yr 3 mo | Substance |
| 8778960 | Feb 13, 2032 | in 5 yr 9 mo | U-3136 |
| 8778960 | Feb 13, 2032 | in 5 yr 9 mo | U-3137 |
| 10300054 | May 31, 2033 | in 7 yr 1 mo | ProductU-3140 |
| 10300054 | May 31, 2033 | in 7 yr 1 mo | ProductU-3141 |
| 11707466 | Nov 12, 2041 | in 15 yr 8 mo | Product |
| 11951111 | Nov 12, 2041 | in 15 yr 8 mo | U-3886 |
| 11951111 | Nov 12, 2041 | in 15 yr 8 mo | U-3887 |
| 12390474 | Nov 12, 2041 | in 15 yr 8 mo | Product |
