Register entry
Amicus Therapeutics US, LLC
- Registered sites
- 0
- Drug products
- 3
- Live patents
- 75
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
75Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | May 2027 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Apr 2028 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Feb 2029 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Oct 2031 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Jul 2036 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Mar 2037 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | May 2038 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Aug 2038 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Feb 2039 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Feb 2039 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Feb 2039 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Mar 2039 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Mar 2039 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | May 2041 |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | Jan 2042 |
| OPFOLDA | MIGLUSTAT | Mar 2033 |
| OPFOLDA | MIGLUSTAT | Sept 2035 |
| OPFOLDA | MIGLUSTAT | Dec 2036 |
| OPFOLDA | MIGLUSTAT | Aug 2037 |
| OPFOLDA | MIGLUSTAT | Sept 2038 |
Catalogue
Marketed products
3Showing 3 of 3.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Galafold | migalastat hydrochloride | CAPSULE | NDA |
| OPFOLDA | miglustat | CAPSULE | NDA |
| POMBILITI ATGA | cipaglucosidase alfa-atga | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.