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Orange Book drug · Brand (NDA)

Galafold

Migalastat Hydrochloride

RLDNDA 208623 Amicus Therap US
Approved
Aug 10, 2018
Strengths
1
Listed patents
66

What does the FDA Orange Book show for Galafold?

Galafold contains Migalastat Hydrochloride and is the new drug FDA Orange Book record for NDA 208623. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 208623

New drug application identity from the Orange Book snapshot.

Application holder
Amicus Therapeutics US LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
66

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 123MG BASECAPSULEORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Amicus Therapeutics US LLC

The Orange Book identifies this organization as the applicant responsible for NDA 208623.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

66 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Jan 11, 2042. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 208623 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Migalastat Hydrochloride

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-208623

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 208623
RLDRS
Strength
EQ 123MG BASE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 1 mo ago

  2. Today

  3. Patent 10383864 expires

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

    in 10 mo

  4. Patent 10406143 expires

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

    in 10 mo

  5. Patent 11241422 expires

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

    in 10 mo

  6. Patent 9000011 expires

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

    in 10 mo

  7. Patent 9480682 expires

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

    in 10 mo

  8. Patent 9987263 expires

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

    in 10 mo

  9. Patent 10525045 expires

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

    in 1 yr 9 mo

  10. Patent 10925866 expires

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

    in 1 yr 9 mo

  11. Patent 11033538 expires

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

    in 1 yr 9 mo

  12. Patent 12599595 expires

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

    in 1 yr 9 mo

  13. Patent 9999618 expires

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

    in 1 yr 9 mo

  14. Patent 9999618 expires

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

    in 1 yr 9 mo

  15. Patent 10813921 expires

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

    in 2 yr 7 mo

  16. Patent 8592362 expires

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

    in 2 yr 7 mo

  17. Patent 9095584 expires

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

    in 2 yr 7 mo

  18. Patent RE48608 expires

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

    in 5 yr 4 mo

  19. Patent 12599594 expires

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

    in 10 yr 2 mo

  20. Patent 10076514 expires

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

    in 10 yr 10 mo

  21. Patent 11234972 expires

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

    in 10 yr 10 mo

  22. Patent 10251873 expires

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

    in 12 yr

  23. Patent 10471053 expires

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

    in 12 yr

  24. Patent 10792278 expires

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

    in 12 yr

  25. Patent 10792279 expires

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

    in 12 yr

  26. Patent 10799491 expires

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

    in 12 yr

  27. Patent 10806727 expires

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

    in 12 yr

  28. Patent 10849889 expires

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

    in 12 yr

  29. Patent 10849890 expires

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

    in 12 yr

  30. Patent 10857141 expires

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

    in 12 yr

  31. Patent 10857142 expires

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

    in 12 yr

  32. Patent 10874655 expires

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

    in 12 yr

  33. Patent 10874656 expires

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

    in 12 yr

  34. Patent 10874657 expires

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

    in 12 yr

  35. Patent 11278536 expires

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

    in 12 yr

  36. Patent 11278537 expires

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

    in 12 yr

  37. Patent 11278538 expires

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

    in 12 yr

  38. Patent 11278539 expires

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

    in 12 yr

  39. Patent 11278540 expires

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

    in 12 yr

  40. Patent 11304940 expires

    Listed drug substance patent expiration.

    in 12 yr

  41. Patent 11357761 expires

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

    in 12 yr

  42. Patent 11357762 expires

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

    in 12 yr

  43. Patent 11357763 expires

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

    in 12 yr

  44. Patent 11357764 expires

    Listed drug substance patent expiration.

    in 12 yr

  45. Patent 11357765 expires

    Listed drug substance patent expiration.

    in 12 yr

  46. Patent 11376244 expires

    Listed drug substance patent expiration.

    in 12 yr

  47. Patent 11389436 expires

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

    in 12 yr

  48. Patent 11389437 expires

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

    in 12 yr

  49. Patent 11426396 expires

    Listed drug substance patent expiration.

    in 12 yr

  50. Patent 11458128 expires

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

    in 12 yr

  51. Patent 11612593 expires

    Listed drug substance patent expiration.

    in 12 yr

  52. Patent 11612594 expires

    Listed drug substance patent expiration.

    in 12 yr

  53. Patent 11633387 expires

    Listed drug substance patent expiration.

    in 12 yr

  54. Patent 11666564 expires

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

    in 12 yr

  55. Patent 11786516 expires

    Listed drug substance patent expiration.

    in 12 yr

  56. Patent 11813255 expires

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

    in 12 yr

  57. Patent 12042488 expires

    Listed drug substance patent expiration.

    in 12 yr

  58. Patent 12042489 expires

    Listed drug substance patent expiration.

    in 12 yr

  59. Patent 12042490 expires

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

    in 12 yr

  60. Patent 12109205 expires

    Listed drug substance patent expiration.

    in 12 yr

  61. Patent 12280042 expires

    Listed drug substance patent expiration.

    in 12 yr

  62. Patent 11903938 expires

    Listed drug substance patent expiration.

    in 12 yr 3 mo

  63. Patent 11357784 expires

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

    in 12 yr 9 mo

  64. Patent 11826360 expires

    Listed drug substance patent expiration.

    in 12 yr 9 mo

  65. Patent 11642334 expires

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

    in 12 yr 9 mo

  66. Patent 11622962 expires

    Listed drug substance patent expiration.

    in 12 yr 10 mo

  67. Patent 11633388 expires

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

    in 12 yr 10 mo

  68. Patent 12594268 expires

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

    in 15 yr 1 mo

  69. Patent 11833164 expires

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

    in 15 yr 8 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 10383864: 2027-05-16Patent 10383864Patent 10406143: 2027-05-16Patent 10406143Patent 11241422: 2027-05-16Patent 11241422Patent 9000011: 2027-05-16Patent 9000011Patent 9480682: 2027-05-16Patent 9480682Patent 9987263: 2027-05-16Patent 9987263Patent 10525045: 2028-04-28Patent 10525045Patent 10925866: 2028-04-28Patent 10925866Patent 11033538: 2028-04-28Patent 11033538Patent 12599595: 2028-04-28Patent 12599595Patent 9999618: 2028-04-28Patent 9999618Patent 9999618: 2028-04-28Patent 9999618Patent 10813921: 2029-02-12Patent 10813921Patent 8592362: 2029-02-12Patent 8592362Patent 9095584: 2029-02-12Patent 9095584Patent RE48608: 2031-10-20Patent RE48608Patent 12599594: 2036-07-19Patent 12599594Patent 10076514: 2037-03-15Patent 10076514Patent 11234972: 2037-03-15Patent 11234972Patent 10251873: 2038-05-30Patent 10251873Patent 10471053: 2038-05-30Patent 10471053Patent 10792278: 2038-05-30Patent 10792278Patent 10792279: 2038-05-30Patent 10792279Patent 10799491: 2038-05-30Patent 10799491Patent 10806727: 2038-05-30Patent 10806727Patent 10849889: 2038-05-30Patent 10849889Patent 10849890: 2038-05-30Patent 10849890Patent 10857141: 2038-05-30Patent 10857141Patent 10857142: 2038-05-30Patent 10857142Patent 10874655: 2038-05-30Patent 10874655Patent 10874656: 2038-05-30Patent 10874656Patent 10874657: 2038-05-30Patent 10874657Patent 11278536: 2038-05-30Patent 11278536Patent 11278537: 2038-05-30Patent 11278537Patent 11278538: 2038-05-30Patent 11278538Patent 11278539: 2038-05-30Patent 11278539Patent 11278540: 2038-05-30Patent 11278540Patent 11304940: 2038-05-30Patent 11304940Patent 11357761: 2038-05-30Patent 11357761Patent 11357762: 2038-05-30Patent 11357762Patent 11357763: 2038-05-30Patent 11357763Patent 11357764: 2038-05-30Patent 11357764Patent 11357765: 2038-05-30Patent 11357765Patent 11376244: 2038-05-30Patent 11376244Patent 11389436: 2038-05-30Patent 11389436Patent 11389437: 2038-05-30Patent 11389437Patent 11426396: 2038-05-30Patent 11426396Patent 11458128: 2038-05-30Patent 11458128Patent 11612593: 2038-05-30Patent 11612593Patent 11612594: 2038-05-30Patent 11612594Patent 11633387: 2038-05-30Patent 11633387Patent 11666564: 2038-05-30Patent 11666564Patent 11786516: 2038-05-30Patent 11786516Patent 11813255: 2038-05-30Patent 11813255Patent 12042488: 2038-05-30Patent 12042488Patent 12042489: 2038-05-30Patent 12042489Patent 12042490: 2038-05-30Patent 12042490Patent 12109205: 2038-05-30Patent 12109205Patent 12280042: 2038-05-30Patent 12280042Patent 11903938: 2038-08-17Patent 11903938Patent 11357784: 2039-02-06Patent 11357784Patent 11826360: 2039-02-16Patent 11826360Patent 11642334: 2039-02-20Patent 11642334Patent 11622962: 2039-03-17Patent 11622962Patent 11633388: 2039-03-25Patent 11633388Patent 12594268: 2041-05-23Patent 12594268Patent 11833164: 2042-01-11Patent 11833164
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

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

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10383864in 10 mo
U-2371
10406143in 10 mo
U-2371
11241422in 10 mo
U-2371
9000011in 10 mo
U-2371
9480682in 10 mo
U-2371
9987263in 10 mo
U-2371
10525045in 1 yr 9 mo
U-2371
10925866in 1 yr 9 mo
U-2371
11033538in 1 yr 9 mo
U-2371
12599595in 1 yr 9 mo
U-2371
9999618in 1 yr 9 mo
U-2373
9999618in 1 yr 9 mo
U-2372
10813921in 2 yr 7 mo
U-2371
8592362in 2 yr 7 mo
U-2371Delisted
9095584in 2 yr 7 mo
U-2371
RE48608in 5 yr 4 mo
U-2371
12599594in 10 yr 2 mo
U-2371
10076514in 10 yr 10 mo
U-2371
11234972in 10 yr 10 mo
U-2371
10251873in 12 yr
U-2371
10471053in 12 yr
U-2371
10792278in 12 yr
U-2371
10792279in 12 yr
U-2371
10799491in 12 yr
U-2371
10806727in 12 yr
U-2371
10849889in 12 yr
U-2371
10849890in 12 yr
U-2371
10857141in 12 yr
U-2371
10857142in 12 yr
U-2371
10874655in 12 yr
U-2371
10874656in 12 yr
U-2371
10874657in 12 yr
U-2371
11278536in 12 yr
U-2371
11278537in 12 yr
U-2371
11278538in 12 yr
U-2371
11278539in 12 yr
U-2371
11278540in 12 yr
U-2371
11304940in 12 yr
Substance
11357761in 12 yr
U-2371
11357762in 12 yr
U-2371
11357763in 12 yr
U-2371
11357764in 12 yr
Substance
11357765in 12 yr
Substance
11376244in 12 yr
Substance
11389436in 12 yr
U-2371
11389437in 12 yr
U-2371
11426396in 12 yr
Substance
11458128in 12 yr
U-2371
11612593in 12 yr
Substance
11612594in 12 yr
Substance
11633387in 12 yr
Substance
11666564in 12 yr
U-2371
11786516in 12 yr
Substance
11813255in 12 yr
U-2371
12042488in 12 yr
Substance
12042489in 12 yr
SubstanceU-2371
12042490in 12 yr
U-2371
12109205in 12 yr
SubstanceU-2371
12280042in 12 yr
SubstanceU-2371
11903938in 12 yr 3 mo
SubstanceU-2371
11357784in 12 yr 9 mo
U-2371
11826360in 12 yr 9 mo
Substance
11642334in 12 yr 9 mo
U-2371
11622962in 12 yr 10 mo
Substance
11633388in 12 yr 10 mo
U-2371
12594268in 15 yr 1 mo
U-2371
11833164in 15 yr 8 mo
U-2371

Active-ingredient family

Brand + generics

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

No other applications share this active ingredient.

View full Migalastat Hydrochloride family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Galafold: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 208623 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

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