FDA Orange Book
Generic for INGREZZA Sprinkle
INGREZZA Sprinkle contains valbenazine. 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 INGREZZA Sprinkle is valbenazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 INGREZZA Sprinkle products the Orange Book lists.
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INGREZZA Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 40MG BASE | Marketed (Rx) | None | 1 | AB |
| capsule, oral | EQ 60MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 80MG BASE | Marketed (Rx) | None | 1 | AB |
NDA 218390, held by NEUROCRINE BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic valbenazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 216064 | AB (A-rated, therapeutically equivalent) | April 5, 2024 | EQ 40MG BASE, EQ 80MG BASE |
INGREZZA Sprinkle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8357697 | November 8, 2027 | Method of use | U-1995 | 218390 |
| 8357697 | November 8, 2027 | Method of use | U-3055 | 218390 |
| 8039627 | April 11, 2031 | Drug substance, Drug product | None | 218390 |
| 10851104 | October 28, 2036 | Drug substance | U-1995 | 218390 |
| 10851104 | October 28, 2036 | Drug substance | U-3055 | 218390 |
| 10851103 | October 28, 2036 | Drug substance, Drug product | U-1995 | 218390 |
| 10851103 | October 28, 2036 | Drug substance, Drug product | U-3055 | 218390 |
| 10844058 | October 28, 2036 | Drug substance, Drug product | U-1995 | 218390 |
| 10844058 | October 28, 2036 | Drug substance, Drug product | U-3055 | 218390 |
| 10065952 | October 28, 2036 | Drug substance, Drug product | U-1995 | 218390 |
| 10065952 | October 28, 2036 | Drug substance, Drug product | U-3055 | 218390 |
| 10906903 | December 22, 2036 | Drug substance, Drug product | None | 218390 |
| 10919892 | December 22, 2036 | Drug substance, Drug product | None | 218390 |
| 10906902 | December 22, 2036 | Drug substance, Drug product | None | 218390 |
| 11439629 | October 10, 2037 | Method of use | U-3055 | 218390 |
| 11040029 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10993941 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10952997 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10912771 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10912771 | October 10, 2037 | Method of use | U-3076 | 218390 |
| 10912771 | October 10, 2037 | Method of use | U-3055 | 218390 |
| 10874648 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10874648 | October 10, 2037 | Method of use | U-3055 | 218390 |
| 10874648 | October 10, 2037 | Method of use | U-3046 | 218390 |
| 10857148 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 10857137 | October 10, 2037 | Method of use | U-1995 | 218390 |
| 11311532 | September 18, 2038 | Drug product | U-1995 | 218390 |
| 11311532 | September 18, 2038 | Drug product | U-3055 | 218390 |
| 11026939 | September 18, 2038 | Drug product | U-1995 | 218390 |
| 11026939 | September 18, 2038 | Drug product | U-3055 | 218390 |
| 11654142 | November 14, 2038 | Method of use | U-3055 | 218390 |
| 11026931 | August 14, 2039 | Method of use | U-1995 | 218390 |
| 10940141 | August 10, 2040 | Method of use | U-1995 | 218390 |
INGREZZA Sprinkle exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-925 | New indication | August 18, 2026 | 218390 |
INGREZZA Sprinkle NDC codes
Questions
Is there a generic for INGREZZA Sprinkle?
Yes. The generic name for INGREZZA Sprinkle is valbenazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 INGREZZA Sprinkle products the Orange Book lists.
What is the generic name for INGREZZA Sprinkle?
The active ingredient in INGREZZA Sprinkle is valbenazine, per the FDA Orange Book.
When does the INGREZZA Sprinkle patent expire?
The last patent listed for INGREZZA Sprinkle in the Orange Book expires August 10, 2040. 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.
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