FDA Orange Book · active-ingredient family
Miglustat
Miglustat: 2 brands, 4 generics; first approved Jul 31, 2003; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
10
Next patent expiry
Mar 07, 2033
in 6 yr 6 mo
Brand (NDA) products
Originator applications
Generic (ANDA) products (4)
Abbreviated applications
- MIGLUSTATNAVINTA LLCANDA 2191112025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - MIGLUSTATCHARTWELL RXANDA 2093252022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - EDENBRIDGE PHARMSANDA 2098212020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - MIGLUSTATANI PHARMSANDA 2083422018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
14 d ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12419937 | in 6 yr 6 mo | U-3726 | |
| 11278599 | in 6 yr 6 mo | U-3726 | |
| 10512677 | in 6 yr 6 mo | U-3726 | |
| 11753632 | in 9 yr 1 mo | U-3726 | |
| 10961522 | in 9 yr 1 mo | U-3726 | |
| 10208299 | in 9 yr 1 mo | SubstanceProductU-3726 | |
| 12414985 | in 10 yr 4 mo | U-3726 | |
| 11278601 | in 10 yr 4 mo | ProductU-3726 | |
| 10857212 | in 11 yr | U-3726 | |
| 12246062 | in 12 yr 1 mo | U-3726 |
Approval history
FDA approval span
First approval
23 yr 6 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 2003–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Miglustat: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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