FDA Orange Book
Is there a generic for Igalmi?
Igalmi contains dexmedetomidine. 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 Igalmi (dexmedetomidine). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends November 19, 2028.
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Igalmi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, buccal, sublingual | EQ 0.12MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal, sublingual | EQ 0.18MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215390, held by BIOXCEL THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Igalmi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11786508 | December 29, 2037 | Method of use | U-3698 | 215390 |
| 11839604 | December 29, 2037 | Method of use | U-3756 | 215390 |
| 10792246 | June 26, 2039 | Drug product | U-3350 | 215390 |
| 11517524 | June 26, 2039 | Drug product | U-3645 | 215390 |
| 11497711 | June 26, 2039 | Drug product | U-3645 | 215390 |
| 11478422 | June 26, 2039 | Drug product | None | 215390 |
| 11998529 | July 17, 2040 | Method of use | U-3935 | 215390 |
| 12109196 | July 17, 2040 | Method of use | U-3935 | 215390 |
| 11890272 | July 17, 2040 | Method of use | U-3935 | 215390 |
| 11890272 | July 17, 2040 | Method of use | U-3756 | 215390 |
| 12364683 | January 12, 2043 | Method of use | U-4029 | 215390 |
| 11998528 | January 12, 2043 | Method of use | U-3935 | 215390 |
| 11806334 | January 12, 2043 | Method of use | U-3725 | 215390 |
| 12090140 | January 12, 2043 | Method of use | U-3986 | 215390 |
| 12138247 | January 12, 2043 | Method of use | U-4029 | 215390 |
Igalmi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-82 | Miscellaneous | November 19, 2028 | 215390 |
Igalmi NDC codes
Questions
Is there a generic for Igalmi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Igalmi (dexmedetomidine). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends November 19, 2028.
What is the generic name for Igalmi?
The active ingredient in Igalmi is dexmedetomidine, per the FDA Orange Book.
When does the Igalmi patent expire?
The last patent listed for Igalmi in the Orange Book expires January 12, 2043. 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.