Register entry
- Registered sites
- 0
- Active NDC listings
- 3
- Labeller names
- 2
- Live patents
- 75
- Countries
- 0
Catalogue
Drug listings by form and route
33 active NDC listings: 3 human prescription drug. By marketing category: NDA 2, BLA 1.
| Dosage form | NDCs |
|---|---|
| capsule | 2 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| oral | 2 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| amicus therapeutics us, llc | 2 |
| amicus therapeutics us, llc | 1 |
Exclusivity
Patents and exclusivities
75| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10383864 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 10406143 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 11241422 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 9000011 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 9480682 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 9987263 | GALAFOLDmigalastat hydrochloride | use | May 2027 |
| 10525045 | GALAFOLDmigalastat hydrochloride | use | Apr 2028 |
| 10925866 | GALAFOLDmigalastat hydrochloride | use | Apr 2028 |
| 11033538 | GALAFOLDmigalastat hydrochloride | use | Apr 2028 |
| 12599595 | GALAFOLDmigalastat hydrochloride | use | Apr 2028 |
| 9999618 | GALAFOLDmigalastat hydrochloride | use | Apr 2028 |
| 10813921 | GALAFOLDmigalastat hydrochloride | use | Feb 2029 |
| 9095584 | GALAFOLDmigalastat hydrochloride | use | Feb 2029 |
| RE48608 | GALAFOLDmigalastat hydrochloride | use | Oct 2031 |
| 10512677 | OPFOLDAmiglustat | use | Mar 2033 |
| 11278599 | OPFOLDAmiglustat | use | Mar 2033 |
| 12419937 | OPFOLDAmiglustat | use | Mar 2033 |
| 10208299 | OPFOLDAmiglustat | substance, product | Sept 2035 |
| 10961522 | OPFOLDAmiglustat | use | Sept 2035 |
| 11753632 | OPFOLDAmiglustat | use | Sept 2035 |
| 12599594 | GALAFOLDmigalastat hydrochloride | use | Jul 2036 |
| 11278601 | OPFOLDAmiglustat | product | Dec 2036 |
| 12414985 | OPFOLDAmiglustat | use | Dec 2036 |
| 10076514 | GALAFOLDmigalastat hydrochloride | use | Mar 2037 |
| 11234972 | GALAFOLDmigalastat hydrochloride | use | Mar 2037 |
| 10857212 | OPFOLDAmiglustat | use | Aug 2037 |
| 10251873 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10471053 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10792278 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10792279 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10799491 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10806727 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10849889 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10849890 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10857141 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10857142 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10874655 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10874656 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 10874657 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11278536 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11278537 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11278538 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11278539 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11278540 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11304940 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11357761 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11357762 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11357763 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11357764 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11357765 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11376244 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11389436 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11389437 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11426396 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11458128 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11612593 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11612594 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11633387 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
| 11666564 | GALAFOLDmigalastat hydrochloride | use | May 2038 |
| 11786516 | GALAFOLDmigalastat hydrochloride | substance | May 2038 |
Catalogue
Marketed products
3| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Galafold | migalastat hydrochloride | capsule, oral | 71904-100NDA |
| OPFOLDA | miglustat | capsule, oral | 71904-300NDA |
| POMBILITI ATGA | cipaglucosidase alfa-atga | injection, powder, lyophilized, for solution, intravenous | 71904-200BLA |
Compare
Other companies listing cipaglucosidase alfa-atga
- WuXi Biologics Co., Ltd.18 sites · 10 NDC
Enquiry
Common questions
- Is Amicus Therapeutics US, LLC FDA approved?
- Amicus Therapeutics US, LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Amicus Therapeutics US, LLC make?
- 3 products are listed under Amicus Therapeutics US, LLC in the openFDA NDC Directory, most often as capsule; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.