Orange Book product · Brand (NDA)
ZYNRELEF KIT
BUPIVACAINE; MELOXICAM
At a glance
May 12, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 12, 2021
5 yr 2 mo ago
Today
Exclusivity ends · I-933
New indication exclusivity (3 years)
Jan 23, 2027
in 7 mo
Patent 10398686 expires
Listed drug product patent expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 11253504 expires
Listed method-of-use patent (U-3118) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9592227 expires
Listed drug product patent expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9744163 expires
Listed drug product patent expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9913909 expires
Listed method-of-use patent (U-3118) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 10098957 expires
Listed method-of-use patent (U-3118) expiration.
Apr 20, 2035
in 9 yr
Patent 10213510 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 10632199 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 10898575 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 10980886 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 11083730 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 11083797 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 11413350 expires
Listed method-of-use patent (U-3417) expiration.
Apr 20, 2035
in 9 yr
Patent 9694079 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 9801945 expires
Listed drug product patent expiration.
Apr 20, 2035
in 9 yr
Patent 11844837 expires
Listed method-of-use patent (U-3417) expiration.
Apr 21, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
BUPIVACAINE; MELOXICAM
Strength
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)
Dosage form
SOLUTION, EXTENDED RELEASE
Route
PERIARTICULAR
TE code
Not listed
Application
NDA 211988
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.
Marketing exclusivity (1)
- I-933New indication exclusivity (3 years)
Jan 23, 2027
in 7 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10398686 | Mar 13, 2034 | in 7 yr 10 mo | Product |
| 11253504 | Mar 13, 2034 | in 7 yr 10 mo | U-3118 |
| 9592227 | Mar 13, 2034 | in 7 yr 10 mo | ProductU-3118 |
| 9744163 | Mar 13, 2034 | in 7 yr 10 mo | Product |
| 9913909 | Mar 13, 2034 | in 7 yr 10 mo | U-3118 |
| 10098957 | Apr 20, 2035 | in 9 yr | U-3118 |
| 10213510 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 10632199 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 10898575 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 10980886 | Apr 20, 2035 | in 9 yr | Product |
| 11083730 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 11083797 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 11413350 | Apr 20, 2035 | in 9 yr | U-3417 |
| 9694079 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 9801945 | Apr 20, 2035 | in 9 yr | ProductU-3118 |
| 11844837 | Apr 21, 2036 | in 10 yr | U-3417 |
