Orange Book product · Brand (NDA)
EXPAREL
BUPIVACAINE
At a glance
Oct 28, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
24
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2011
14 yr 10 mo ago
Today
Exclusivity ends · I-929
New indication exclusivity (3 years)
Nov 09, 2026
in 5 mo
Patent 11033495 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11179336 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11278494 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11304904 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11311486 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11357727 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11426348 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11452691 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11819574 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11819575 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11925706 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12144890 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12151024 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 12296047 expires
Listed drug product patent expiration.
Jan 22, 2041
in 14 yr 10 mo
Patent 11931459 expires
Listed method-of-use patent (U-3840) expiration.
Mar 17, 2042
in 16 yr
Patent 11931459 expires
Listed method-of-use patent (U-3839) expiration.
Mar 17, 2042
in 16 yr
Patent 11918565 expires
Listed method-of-use patent (U-3841) expiration.
Feb 02, 2043
in 16 yr 10 mo
Patent 12226610 expires
Listed method-of-use patent (U-4148) expiration.
Feb 02, 2043
in 16 yr 10 mo
Patent 12226610 expires
Listed method-of-use patent (U-4149) expiration.
Feb 02, 2043
in 16 yr 10 mo
Patent 12226610 expires
Listed method-of-use patent (U-4150) expiration.
Feb 02, 2043
in 16 yr 10 mo
Patent 12156940 expires
Listed drug product patent expiration.
Jul 02, 2044
in 18 yr 4 mo
Patent 12251468 expires
Listed drug product patent expiration.
Jul 02, 2044
in 18 yr 4 mo
Patent 12318483 expires
Listed method-of-use patent (U-4152) expiration.
Jul 02, 2044
in 18 yr 4 mo
Patent 12370142 expires
Listed drug product patent expiration.
Jul 02, 2044
in 18 yr 4 mo
Pharmaceutical detail
Active ingredient
BUPIVACAINE
Strength
266MG/20ML (13.3MG/ML)
Dosage form
INJECTABLE, LIPOSOMAL
Route
INJECTION
TE code
Not listed
Application
NDA 022496
Product number
002
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)
- I-929New indication exclusivity (3 years)
Nov 09, 2026
in 5 mo
Listed patents (24)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11033495 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3182 |
| 11179336 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3250 |
| 11278494 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3250 |
| 11304904 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3346 |
| 11311486 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3250 |
| 11357727 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3380 |
| 11426348 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3380 |
| 11452691 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3439 |
| 11819574 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3250 |
| 11819575 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3250 |
| 11925706 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-3380 |
| 12144890 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-4033 |
| 12151024 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-4037 |
| 12296047 | Jan 22, 2041 | in 14 yr 10 mo | ProductU-4184 |
| 11931459 | Mar 17, 2042 | in 16 yr | U-3840 |
| 11931459 | Mar 17, 2042 | in 16 yr | U-3839 |
| 11918565 | Feb 02, 2043 | in 16 yr 10 mo | U-3841 |
| 12226610 | Feb 02, 2043 | in 16 yr 10 mo | U-4148 |
| 12226610 | Feb 02, 2043 | in 16 yr 10 mo | U-4149 |
| 12226610 | Feb 02, 2043 | in 16 yr 10 mo | U-4150 |
| 12156940 | Jul 02, 2044 | in 18 yr 4 mo | Product |
| 12251468 | Jul 02, 2044 | in 18 yr 4 mo | ProductU-4152 |
| 12318483 | Jul 02, 2044 | in 18 yr 4 mo | U-4152 |
| 12370142 | Jul 02, 2044 | in 18 yr 4 mo | ProductU-4152 |
