FDA Orange Book
Is there a generic for Opfolda?
Opfolda contains miglustat. 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 Opfolda (miglustat). The Orange Book shows its last listed patent expires September 16, 2038 and its last listed exclusivity ends September 28, 2026.
Run it in Rivvi
Map Opfolda and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Opfolda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 65MG | Marketed (Rx) | None | 0 | None |
NDA 215211, 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.
Opfolda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12419937 | March 7, 2033 | Method of use | U-3726 | 215211 |
| 11278599 | March 7, 2033 | Method of use | U-3726 | 215211 |
| 10512677 | March 7, 2033 | Method of use | U-3726 | 215211 |
| 11753632 | September 30, 2035 | Method of use | U-3726 | 215211 |
| 10961522 | September 30, 2035 | Method of use | U-3726 | 215211 |
| 10208299 | September 30, 2035 | Drug substance, Drug product | U-3726 | 215211 |
| 12414985 | December 29, 2036 | Method of use | U-3726 | 215211 |
| 11278601 | December 29, 2036 | Drug product | U-3726 | 215211 |
| 10857212 | August 12, 2037 | Method of use | U-3726 | 215211 |
| 12246062 | September 16, 2038 | Method of use | U-3726 | 215211 |
Opfolda exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | September 28, 2026 | 215211 |
Opfolda NDC codes
Questions
Is there a generic for Opfolda?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opfolda (miglustat). The Orange Book shows its last listed patent expires September 16, 2038 and its last listed exclusivity ends September 28, 2026.
What is the generic name for Opfolda?
The active ingredient in Opfolda is miglustat, per the FDA Orange Book.
When does the Opfolda patent expire?
The last patent listed for Opfolda in the Orange Book expires September 16, 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.