| Migalastat Hydrochloride | Amicus Therapeutics | ||
| 123 mg; Capsule |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
Less Than 5
|
||
| None | None | ||
| GALAFOLD™ is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. | |||
|
Yes
| |||
| Galafold | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 | Patent 32 | Patent 33 | Patent 34 | Patent 35 | Patent 36 | Patent 37 | Patent 38 | Patent 39 | Patent 40 | Patent 41 | Patent 42 | Patent 43 | Patent 44 | Patent 45 | Patent 46 | Patent 47 | Patent 48 | Patent 49 | Patent 50 | Patent 51 | Patent 52 | Patent 53 | Patent 54 | Patent 55 | Patent 56 | Patent 57 | Patent 58 | Patent 59 | Patent 60 | Patent 61 | Patent 62 | Patent 63 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **** | ******** *** ** *** | ******* | ******** *** ** *** | ******** *** ** *** | ******* | ******** *** ** *** | ****** *** | ******** *** ** *** | ******* | ******* | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******* | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******* | ******** *** ** *** | ******** *** ** *** | ******* | ******** *** ** *** | ****** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******** *** ** *** | ******* | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******** *** ** *** (***** ******) | ******* (***** ******) | ******* (***** ******) | ******** *** ** *** (***** ******) | ******* (***** ******) | ******* (***** ******) | *** ********* (***** ******) | ******* (***** ******) | ******* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ***** | *** ********* | **** ** **** *, **** | *** ********* | *** ********* | **** ** **** *, **** | *** ********* | *** ********* | *** ********* | **** ** **** *, **** | **** ** **** *, **** | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** **** *, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** **** *, **** | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** **** *, **** | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | ****** *** | ******** *** ** *** | *** ********* | *** ********* | ******** *** ** *** | *** ********* | ******** *** ** *** | **** ** *** **, **** | ******** *** ** *** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** | ******** *** ** *** | ******** *** ** *** | **** ** *** **, **** | ******** *** ** *** | **** ** *** **, **** | *** ********* | *** ********* | ****** *** | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* (***** ******) | *** **, **** (***** ******) | *** **, **** (***** ******) | *** ********* (***** ******) | *** **, **** (***** ******) | *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| **** | *** \ ********* | *** **, **** | ******* | **** | ** *** **, **** |
| ***** | *** \ ********* | *** **, **** | ******* | ********* ******** | *** ****** *** **** |
| ********* | *** \ ********* | *** **, **** | ******* | **** | *** ****** *** **** |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|