FDA Orange Book · active-ingredient family
Miglustat
Miglustat is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OPFOLDA · NDA 215211
2
Brand (NDA)
4
Generics (ANDA)
10
Listed patents
1
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OPFOLDARLD | AMICUS THERAP US | NDA 215211 | — | Sep 28, 2023 | |
| ZAVESCARLD | ACTELION | NDA 021348 | AB | Jul 31, 2003 |
Generic (ANDA) products (4)
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Sep 28, 2026
in 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12419937 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 11278599 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 10512677 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 11753632 | Sep 30, 2035 | in 9 yr 5 mo | U-3726 |
| 10961522 | Sep 30, 2035 | in 9 yr 5 mo | U-3726 |
| 10208299 | Sep 30, 2035 | in 9 yr 5 mo | SubstanceProductU-3726 |
| 12414985 | Dec 29, 2036 | in 10 yr 8 mo | U-3726 |
| 11278601 | Dec 29, 2036 | in 10 yr 8 mo | ProductU-3726 |
| 10857212 | Aug 12, 2037 | in 11 yr 4 mo | U-3726 |
| 12246062 | Sep 16, 2038 | in 12 yr 5 mo | U-3726 |
Miglustat — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
