FDA Orange Book
Is there a generic for Exparel?
Exparel contains bupivacaine. 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 Exparel (bupivacaine). The Orange Book shows its last listed patent expires July 2, 2044 and its last listed exclusivity ends November 9, 2026.
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Exparel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, liposomal, injection | 133MG/10ML (13.3MG/ML) | Marketed (Rx) | None | 0 | None |
| injectable, liposomal, injection | 266MG/20ML (13.3MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 022496, held by PACIRA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Exparel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11452691 | January 22, 2041 | Drug product | U-3439 | 022496 |
| 11819575 | January 22, 2041 | Drug product | U-3250 | 022496 |
| 11033495 | January 22, 2041 | Drug product | U-3182 | 022496 |
| 12144890 | January 22, 2041 | Drug product | U-4033 | 022496 |
| 11179336 | January 22, 2041 | Drug product | U-3250 | 022496 |
| 11426348 | January 22, 2041 | Drug product | U-3380 | 022496 |
| 12296047 | January 22, 2041 | Drug product | U-4184 | 022496 |
| 11357727 | January 22, 2041 | Drug product | U-3380 | 022496 |
| 11311486 | January 22, 2041 | Drug product | U-3250 | 022496 |
| 11278494 | January 22, 2041 | Drug product | U-3250 | 022496 |
| 11304904 | January 22, 2041 | Drug product | U-3346 | 022496 |
| 11819574 | January 22, 2041 | Drug product | U-3250 | 022496 |
| 11925706 | January 22, 2041 | Drug product | U-3380 | 022496 |
| 12151024 | January 22, 2041 | Drug product | U-4037 | 022496 |
| 11931459 | March 17, 2042 | Method of use | U-3839 | 022496 |
| 11931459 | March 17, 2042 | Method of use | U-3840 | 022496 |
| 12226610 | February 2, 2043 | Method of use | U-4148 | 022496 |
| 12226610 | February 2, 2043 | Method of use | U-4149 | 022496 |
| 12226610 | February 2, 2043 | Method of use | U-4150 | 022496 |
| 11918565 | February 2, 2043 | Method of use | U-3841 | 022496 |
| 12318483 | July 2, 2044 | Method of use | U-4152 | 022496 |
| 12370142 | July 2, 2044 | Drug product | U-4152 | 022496 |
| 12251468 | July 2, 2044 | Drug product | U-4152 | 022496 |
| 12728094 | July 2, 2044 | Drug product | U-4152 | 022496 |
| 12728095 | July 2, 2044 | Drug product | U-4152 | 022496 |
| 12156940 | July 2, 2044 | Drug product | None | 022496 |
Exparel exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-929 | New indication | November 9, 2026 | 022496 |
Exparel NDC codes
Questions
Is there a generic for Exparel?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Exparel (bupivacaine). The Orange Book shows its last listed patent expires July 2, 2044 and its last listed exclusivity ends November 9, 2026.
What is the generic name for Exparel?
The active ingredient in Exparel is bupivacaine, per the FDA Orange Book.
When does the Exparel patent expire?
The last patent listed for Exparel in the Orange Book expires July 2, 2044. 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.