FDA Orange Book
Is there a generic for Zynrelef Kit?
Zynrelef Kit contains bupivacaine and meloxicam. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zynrelef Kit (bupivacaine and meloxicam). The Orange Book shows its last listed patent expires April 21, 2036 and its last listed exclusivity ends January 23, 2027.
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Zynrelef Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, extended release, periarticular | 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, extended release, periarticular | 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) | Discontinued | None | 0 | None |
| solution, extended release, periarticular | 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, extended release, periarticular | 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) | Discontinued | None | 0 | None |
NDA 211988, held by HERON THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zynrelef Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9592227 | March 13, 2034 | Drug product | U-3118 | 211988 |
| 9913909 | March 13, 2034 | Method of use | U-3118 | 211988 |
| 11253504 | March 13, 2034 | Method of use | U-3118 | 211988 |
| 10398686 | March 13, 2034 | Drug product | None | 211988 |
| 9744163 | March 13, 2034 | Drug product | None | 211988 |
| 11413350 | April 20, 2035 | Method of use | U-3417 | 211988 |
| 9694079 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 9801945 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 10213510 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 10098957 | April 20, 2035 | Method of use | U-3118 | 211988 |
| 10632199 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 10898575 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 11083797 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 11083730 | April 20, 2035 | Drug product | U-3118 | 211988 |
| 10980886 | April 20, 2035 | Drug product | None | 211988 |
| 11844837 | April 21, 2036 | Method of use | U-3417 | 211988 |
Zynrelef Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-933 | New indication | January 23, 2027 | 211988 |
Zynrelef Kit NDC codes
Questions
Is there a generic for Zynrelef Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zynrelef Kit (bupivacaine and meloxicam). The Orange Book shows its last listed patent expires April 21, 2036 and its last listed exclusivity ends January 23, 2027.
What is the generic name for Zynrelef Kit?
The active ingredient in Zynrelef Kit is bupivacaine and meloxicam, per the FDA Orange Book.
When does the Zynrelef Kit patent expire?
The last patent listed for Zynrelef Kit in the Orange Book expires April 21, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.