Orange Book product · Brand (NDA)
POSIMIR
BUPIVACAINE
Brand (NDA)NDA 204803DISCN INNOCOLL
At a glance
Feb 01, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2021
5 yr 5 mo ago
Today
Patent 11400019 expires
Listed drug product patent expiration.
Jan 12, 2041
in 14 yr 9 mo
Patent 11771624 expires
Listed method-of-use patent (U-3724) expiration.
Jan 12, 2041
in 14 yr 9 mo
Pharmaceutical detail
Active ingredient
BUPIVACAINE
Strength
660MG/5ML (132MG/ML)
Dosage form
SOLUTION
Route
INFILTRATION
TE code
Not listed
Application
NDA 204803
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11400019 | Jan 12, 2041 | in 14 yr 9 mo | Product |
| 11771624 | Jan 12, 2041 | in 14 yr 9 mo | U-3724 |
