Orange Book product · Brand (NDA)
OPFOLDA
MIGLUSTAT
At a glance
Sep 28, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Sep 28, 2026
in 3 mo
Patent 10512677 expires
Listed method-of-use patent (U-3726) expiration.
Mar 07, 2033
in 6 yr 10 mo
Patent 11278599 expires
Listed method-of-use patent (U-3726) expiration.
Mar 07, 2033
in 6 yr 10 mo
Patent 12419937 expires
Listed method-of-use patent (U-3726) expiration.
Mar 07, 2033
in 6 yr 10 mo
Patent 10208299 expires
Listed drug substance patent expiration.
Sep 30, 2035
in 9 yr 5 mo
Patent 10961522 expires
Listed method-of-use patent (U-3726) expiration.
Sep 30, 2035
in 9 yr 5 mo
Patent 11753632 expires
Listed method-of-use patent (U-3726) expiration.
Sep 30, 2035
in 9 yr 5 mo
Patent 11278601 expires
Listed drug product patent expiration.
Dec 29, 2036
in 10 yr 8 mo
Patent 12414985 expires
Listed method-of-use patent (U-3726) expiration.
Dec 29, 2036
in 10 yr 8 mo
Patent 10857212 expires
Listed method-of-use patent (U-3726) expiration.
Aug 12, 2037
in 11 yr 4 mo
Patent 12246062 expires
Listed method-of-use patent (U-3726) expiration.
Sep 16, 2038
in 12 yr 5 mo
Pharmaceutical detail
Active ingredient
MIGLUSTAT
Strength
65MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215211
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Sep 28, 2026
in 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10512677 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 11278599 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 12419937 | Mar 07, 2033 | in 6 yr 10 mo | U-3726 |
| 10208299 | Sep 30, 2035 | in 9 yr 5 mo | SubstanceProductU-3726 |
| 10961522 | Sep 30, 2035 | in 9 yr 5 mo | U-3726 |
| 11753632 | Sep 30, 2035 | in 9 yr 5 mo | U-3726 |
| 11278601 | Dec 29, 2036 | in 10 yr 8 mo | ProductU-3726 |
| 12414985 | Dec 29, 2036 | in 10 yr 8 mo | U-3726 |
| 10857212 | Aug 12, 2037 | in 11 yr 4 mo | U-3726 |
| 12246062 | Sep 16, 2038 | in 12 yr 5 mo | U-3726 |
