FDA Orange Book
Is there a generic for Gimoti?
Gimoti contains metoclopramide. 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 Gimoti (metoclopramide). The Orange Book shows its last listed patent expires November 17, 2038.
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Gimoti products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | EQ 15MG BASE/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 209388, held by QOL MEDICAL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gimoti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11020361 | December 22, 2029 | Method of use | U-2843 | 209388 |
| 12194009 | December 22, 2029 | Method of use | U-2843 | 209388 |
| 12194008 | December 22, 2029 | Method of use | U-2843 | 209388 |
| 11628150 | December 22, 2029 | Drug product | U-2843 | 209388 |
| 11813231 | December 22, 2029 | Drug product | U-2843 | 209388 |
| 8334281 | May 16, 2030 | Drug product | U-2843 | 209388 |
| 12377064 | November 17, 2038 | Method of use | U-2843 | 209388 |
Gimoti NDC codes
Questions
Is there a generic for Gimoti?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gimoti (metoclopramide). The Orange Book shows its last listed patent expires November 17, 2038.
What is the generic name for Gimoti?
The active ingredient in Gimoti is metoclopramide, per the FDA Orange Book.
When does the Gimoti patent expire?
The last patent listed for Gimoti in the Orange Book expires November 17, 2038. 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.