FDA Orange Book
Generic for Rexulti
Rexulti contains brexpiprazole. 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
Yes. The generic name for Rexulti is brexpiprazole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rexulti products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.25MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 3MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 1 | AB |
NDA 205422, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brexpiprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 213683 | AB (A-rated, therapeutically equivalent) | January 13, 2025 | 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG |
Rexulti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9839637 | April 12, 2026 | Drug product | U-1529 | 205422 |
| 8618109 | April 12, 2026 | Method of use | U-543 | 205422 |
| 8349840 | April 12, 2026 | Drug product | U-1529 | 205422 |
| 9839637 | April 12, 2026 | Drug product | U-3281 | 205422 |
| 8618109 | April 12, 2026 | Method of use | U-3281 | 205422 |
| 9839637 | April 12, 2026 | Drug product | U-543 | 205422 |
| 9839637*PED | October 12, 2026 | Method of use | None | 205422 |
| 8618109*PED | October 12, 2026 | Method of use | None | 205422 |
| 8349840*PED | October 12, 2026 | Method of use | None | 205422 |
| RE48059 | December 23, 2028 | Drug substance | None | 205422 |
| RE48059*PED | June 23, 2029 | Method of use | None | 205422 |
| 10307419 | October 12, 2032 | Drug product | None | 205422 |
| 10307419*PED | April 12, 2033 | Method of use | None | 205422 |
Rexulti exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-913 | New indication | May 10, 2026 | 205422 |
| PED | Pediatric exclusivity | November 10, 2026 | 205422 |
| M-14 | Miscellaneous | May 8, 2027 | 205422 |
| PED | Pediatric exclusivity | November 8, 2027 | 205422 |
| M-315 | Miscellaneous | May 9, 2028 | 205422 |
Rexulti NDC codes
Questions
Is there a generic for Rexulti?
Yes. The generic name for Rexulti is brexpiprazole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Rexulti?
The active ingredient in Rexulti is brexpiprazole, per the FDA Orange Book.
When does the Rexulti patent expire?
The last patent listed for Rexulti in the Orange Book expires April 12, 2033. 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.