Assyro AI

Orange Book product · Brand (NDA)

GALAFOLD

MIGALASTAT HYDROCHLORIDE

Brand (NDA)NDA 208623RX AMICUS THERAP US
View MIGALASTAT HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 10, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

67

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 10, 2018

    8 yr ago

  2. Today

  3. Patent 10383864 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  4. Patent 10406143 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  5. Patent 11241422 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  6. Patent 9000011 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  7. Patent 9480682 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  8. Patent 9987263 expires

    Listed method-of-use patent (U-2371) expiration.

    May 16, 2027

    in 11 mo

  9. Patent 10525045 expires

    Listed method-of-use patent (U-2371) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  10. Patent 10925866 expires

    Listed method-of-use patent (U-2371) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  11. Patent 11033538 expires

    Listed method-of-use patent (U-2371) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  12. Patent 12599595 expires

    Listed method-of-use patent (U-2371) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  13. Patent 9999618 expires

    Listed method-of-use patent (U-2373) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  14. Patent 9999618 expires

    Listed method-of-use patent (U-2372) expiration.

    Apr 28, 2028

    in 1 yr 11 mo

  15. Patent 10813921 expires

    Listed method-of-use patent (U-2371) expiration.

    Feb 12, 2029

    in 2 yr 8 mo

  16. Patent 8592362 expires

    Listed method-of-use patent (U-2371) expiration.

    Feb 12, 2029

    in 2 yr 8 mo

  17. Patent 9095584 expires

    Listed method-of-use patent (U-2371) expiration.

    Feb 12, 2029

    in 2 yr 8 mo

  18. Patent RE48608 expires

    Listed method-of-use patent (U-2371) expiration.

    Oct 20, 2031

    in 5 yr 5 mo

  19. Patent 12599594 expires

    Listed method-of-use patent (U-2371) expiration.

    Jul 19, 2036

    in 10 yr 3 mo

  20. Patent 10076514 expires

    Listed method-of-use patent (U-2371) expiration.

    Mar 15, 2037

    in 10 yr 11 mo

  21. Patent 11234972 expires

    Listed method-of-use patent (U-2371) expiration.

    Mar 15, 2037

    in 10 yr 11 mo

  22. Patent 10251873 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  23. Patent 10471053 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  24. Patent 10792278 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  25. Patent 10792279 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  26. Patent 10799491 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  27. Patent 10806727 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  28. Patent 10849889 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  29. Patent 10849890 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  30. Patent 10857141 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  31. Patent 10857142 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  32. Patent 10874655 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  33. Patent 10874656 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  34. Patent 10874657 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  35. Patent 11278536 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  36. Patent 11278537 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  37. Patent 11278538 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  38. Patent 11278539 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  39. Patent 11278540 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  40. Patent 11304940 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  41. Patent 11357761 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  42. Patent 11357762 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  43. Patent 11357763 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  44. Patent 11357764 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  45. Patent 11357765 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  46. Patent 11376244 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  47. Patent 11389436 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  48. Patent 11389437 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  49. Patent 11426396 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  50. Patent 11458128 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  51. Patent 11612593 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  52. Patent 11612594 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  53. Patent 11633387 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  54. Patent 11666564 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  55. Patent 11786516 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  56. Patent 11813255 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  57. Patent 12042488 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  58. Patent 12042489 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  59. Patent 12042490 expires

    Listed method-of-use patent (U-2371) expiration.

    May 30, 2038

    in 12 yr 1 mo

  60. Patent 12109205 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  61. Patent 12280042 expires

    Listed drug substance patent expiration.

    May 30, 2038

    in 12 yr 1 mo

  62. Patent 11903938 expires

    Listed drug substance patent expiration.

    Aug 17, 2038

    in 12 yr 4 mo

  63. Patent 11357784 expires

    Listed method-of-use patent (U-2371) expiration.

    Feb 06, 2039

    in 12 yr 10 mo

  64. Patent 11826360 expires

    Listed drug substance patent expiration.

    Feb 16, 2039

    in 12 yr 10 mo

  65. Patent 11642334 expires

    Listed method-of-use patent (U-2371) expiration.

    Feb 20, 2039

    in 12 yr 10 mo

  66. Patent 11622962 expires

    Listed drug substance patent expiration.

    Mar 17, 2039

    in 12 yr 11 mo

  67. Patent 11633388 expires

    Listed method-of-use patent (U-2371) expiration.

    Mar 25, 2039

    in 12 yr 11 mo

  68. Patent 12594268 expires

    Listed method-of-use patent (U-2371) expiration.

    May 23, 2041

    in 15 yr 2 mo

  69. Patent 11833164 expires

    Listed method-of-use patent (U-2371) expiration.

    Jan 11, 2042

    in 15 yr 10 mo

Pharmaceutical detail

Active ingredient

MIGALASTAT HYDROCHLORIDE

Strength

EQ 123MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 208623

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (67)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10383864May 16, 2027in 11 mo
U-2371
10406143May 16, 2027in 11 mo
U-2371
11241422May 16, 2027in 11 mo
U-2371
9000011May 16, 2027in 11 mo
U-2371
9480682May 16, 2027in 11 mo
U-2371
9987263May 16, 2027in 11 mo
U-2371
10525045Apr 28, 2028in 1 yr 11 mo
U-2371
10925866Apr 28, 2028in 1 yr 11 mo
U-2371
11033538Apr 28, 2028in 1 yr 11 mo
U-2371
12599595Apr 28, 2028in 1 yr 11 mo
U-2371
9999618Apr 28, 2028in 1 yr 11 mo
U-2373
9999618Apr 28, 2028in 1 yr 11 mo
U-2372
10813921Feb 12, 2029in 2 yr 8 mo
U-2371
8592362Feb 12, 2029in 2 yr 8 mo
U-2371Delisted
9095584Feb 12, 2029in 2 yr 8 mo
U-2371
RE48608Oct 20, 2031in 5 yr 5 mo
U-2371
12599594Jul 19, 2036in 10 yr 3 mo
U-2371
10076514Mar 15, 2037in 10 yr 11 mo
U-2371
11234972Mar 15, 2037in 10 yr 11 mo
U-2371
10251873May 30, 2038in 12 yr 1 mo
U-2371
10471053May 30, 2038in 12 yr 1 mo
U-2371
10792278May 30, 2038in 12 yr 1 mo
U-2371
10792279May 30, 2038in 12 yr 1 mo
U-2371
10799491May 30, 2038in 12 yr 1 mo
U-2371
10806727May 30, 2038in 12 yr 1 mo
U-2371
10849889May 30, 2038in 12 yr 1 mo
U-2371
10849890May 30, 2038in 12 yr 1 mo
U-2371
10857141May 30, 2038in 12 yr 1 mo
U-2371
10857142May 30, 2038in 12 yr 1 mo
U-2371
10874655May 30, 2038in 12 yr 1 mo
U-2371
10874656May 30, 2038in 12 yr 1 mo
U-2371
10874657May 30, 2038in 12 yr 1 mo
U-2371
11278536May 30, 2038in 12 yr 1 mo
U-2371
11278537May 30, 2038in 12 yr 1 mo
U-2371
11278538May 30, 2038in 12 yr 1 mo
U-2371
11278539May 30, 2038in 12 yr 1 mo
U-2371
11278540May 30, 2038in 12 yr 1 mo
U-2371
11304940May 30, 2038in 12 yr 1 mo
Substance
11357761May 30, 2038in 12 yr 1 mo
U-2371
11357762May 30, 2038in 12 yr 1 mo
U-2371
11357763May 30, 2038in 12 yr 1 mo
U-2371
11357764May 30, 2038in 12 yr 1 mo
Substance
11357765May 30, 2038in 12 yr 1 mo
Substance
11376244May 30, 2038in 12 yr 1 mo
Substance
11389436May 30, 2038in 12 yr 1 mo
U-2371
11389437May 30, 2038in 12 yr 1 mo
U-2371
11426396May 30, 2038in 12 yr 1 mo
Substance
11458128May 30, 2038in 12 yr 1 mo
U-2371
11612593May 30, 2038in 12 yr 1 mo
Substance
11612594May 30, 2038in 12 yr 1 mo
Substance
11633387May 30, 2038in 12 yr 1 mo
Substance
11666564May 30, 2038in 12 yr 1 mo
U-2371
11786516May 30, 2038in 12 yr 1 mo
Substance
11813255May 30, 2038in 12 yr 1 mo
U-2371
12042488May 30, 2038in 12 yr 1 mo
Substance
12042489May 30, 2038in 12 yr 1 mo
SubstanceU-2371
12042490May 30, 2038in 12 yr 1 mo
U-2371
12109205May 30, 2038in 12 yr 1 mo
SubstanceU-2371
12280042May 30, 2038in 12 yr 1 mo
SubstanceU-2371
11903938Aug 17, 2038in 12 yr 4 mo
SubstanceU-2371
11357784Feb 06, 2039in 12 yr 10 mo
U-2371
11826360Feb 16, 2039in 12 yr 10 mo
Substance
11642334Feb 20, 2039in 12 yr 10 mo
U-2371
11622962Mar 17, 2039in 12 yr 11 mo
Substance
11633388Mar 25, 2039in 12 yr 11 mo
U-2371
12594268May 23, 2041in 15 yr 2 mo
U-2371
11833164Jan 11, 2042in 15 yr 10 mo
U-2371
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo