FDA Orange Book
Is there a generic for Galafold?
Galafold contains migalastat. 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 Galafold (migalastat). The Orange Book shows its last listed patent expires January 11, 2042.
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Galafold products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 123MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208623, held by AMICUS THERAPEUTICS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Galafold patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9987263 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 9480682 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 9000011 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 10383864 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 10406143 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 11241422 | May 16, 2027 | Method of use | U-2371 | 208623 |
| 9999618 | April 28, 2028 | Method of use | U-2373 | 208623 |
| 9999618 | April 28, 2028 | Method of use | U-2372 | 208623 |
| 10525045 | April 28, 2028 | Method of use | U-2371 | 208623 |
| 11033538 | April 28, 2028 | Method of use | U-2371 | 208623 |
| 10925866 | April 28, 2028 | Method of use | U-2371 | 208623 |
| 12599595 | April 28, 2028 | Method of use | U-2371 | 208623 |
| 9095584 | February 12, 2029 | Method of use | U-2371 | 208623 |
| 8592362 | February 12, 2029 | Method of use | U-2371 | 208623 |
| 10813921 | February 12, 2029 | Method of use | U-2371 | 208623 |
| RE48608 | October 20, 2031 | Method of use | U-2371 | 208623 |
| 12599594 | July 19, 2036 | Method of use | U-2371 | 208623 |
| 10076514 | March 15, 2037 | Method of use | U-2371 | 208623 |
| 11234972 | March 15, 2037 | Method of use | U-2371 | 208623 |
| 10251873 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10471053 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 12280042 | May 30, 2038 | Drug substance | U-2371 | 208623 |
| 12042490 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 12042489 | May 30, 2038 | Drug substance | U-2371 | 208623 |
| 11357761 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11357762 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11357763 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11458128 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11666564 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 12109205 | May 30, 2038 | Drug substance | U-2371 | 208623 |
| 10857141 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10849890 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10849889 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10857142 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10874657 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10874655 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10874656 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11389437 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11389436 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10792278 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10792279 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10799491 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 10806727 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11813255 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11278538 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11278537 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11278536 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11278539 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11278540 | May 30, 2038 | Method of use | U-2371 | 208623 |
| 11304940 | May 30, 2038 | Drug substance | None | 208623 |
| 11612594 | May 30, 2038 | Drug substance | None | 208623 |
| 12042488 | May 30, 2038 | Drug substance | None | 208623 |
| 11357764 | May 30, 2038 | Drug substance | None | 208623 |
| 11376244 | May 30, 2038 | Drug substance | None | 208623 |
| 11612593 | May 30, 2038 | Drug substance | None | 208623 |
| 11357765 | May 30, 2038 | Drug substance | None | 208623 |
| 11426396 | May 30, 2038 | Drug substance | None | 208623 |
| 11633387 | May 30, 2038 | Drug substance | None | 208623 |
| 11786516 | May 30, 2038 | Drug substance | None | 208623 |
| 11903938 | August 17, 2038 | Drug substance | U-2371 | 208623 |
Showing 60 of 67 listed patents.
Galafold NDC codes
Questions
Is there a generic for Galafold?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Galafold (migalastat). The Orange Book shows its last listed patent expires January 11, 2042.
What is the generic name for Galafold?
The active ingredient in Galafold is migalastat, per the FDA Orange Book.
When does the Galafold patent expire?
The last patent listed for Galafold in the Orange Book expires January 11, 2042. 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.