cliffwatch

migalastat hydrochloride · Amicus Therap Us · NDA 208623

Galafold

Earliest generic entry, as listed
11 Jan 2042

Blocked by patent: US 11833164. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 65 unexpired

66 Orange Book listing rows for 65 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11833164use U-2371 · sets the listed date11 Jan 2042
US 12594268use U-237123 May 2041
US 11633388use U-237125 Mar 2039
US 11622962drug substance17 Mar 2039
US 11642334use U-237120 Feb 2039
US 11826360drug substance16 Feb 2039
US 11357784use U-23716 Feb 2039
US 11903938drug substance, use U-237117 Aug 2038
US 10251873use U-237130 May 2038
US 10471053use U-237130 May 2038
US 10792278use U-237130 May 2038
US 10792279use U-237130 May 2038
US 10799491use U-237130 May 2038
US 10806727use U-237130 May 2038
US 10849889use U-237130 May 2038
US 10849890use U-237130 May 2038
US 10857141use U-237130 May 2038
US 10857142use U-237130 May 2038
US 10874655use U-237130 May 2038
US 10874656use U-237130 May 2038
US 10874657use U-237130 May 2038
US 11278536use U-237130 May 2038
US 11278537use U-237130 May 2038
US 11278538use U-237130 May 2038
US 11278539use U-237130 May 2038
US 11278540use U-237130 May 2038
US 11304940drug substance30 May 2038
US 11357761use U-237130 May 2038
US 11357762use U-237130 May 2038
US 11357763use U-237130 May 2038
US 11357764drug substance30 May 2038
US 11357765drug substance30 May 2038
US 11376244drug substance30 May 2038
US 11389436use U-237130 May 2038
US 11389437use U-237130 May 2038
US 11426396drug substance30 May 2038
US 11458128use U-237130 May 2038
US 11612593drug substance30 May 2038
US 11612594drug substance30 May 2038
US 11633387drug substance30 May 2038
US 11666564use U-237130 May 2038
US 11786516drug substance30 May 2038
US 11813255use U-237130 May 2038
US 12042488drug substance30 May 2038
US 12042489drug substance, use U-237130 May 2038
US 12042490use U-237130 May 2038
US 12109205drug substance, use U-237130 May 2038
US 12280042drug substance, use U-237130 May 2038
US 10076514use U-237115 Mar 2037
US 11234972use U-237115 Mar 2037
US 12599594use U-237119 Jul 2036
US RE48608use U-237120 Oct 2031
US 10813921use U-237112 Feb 2029
US 9095584use U-237112 Feb 2029
US 10525045use U-237128 Apr 2028
US 10925866use U-237128 Apr 2028
US 11033538use U-237128 Apr 2028
US 12599595use U-237128 Apr 2028
US 9999618use U-2372, U-237328 Apr 2028
US 9999618 listing rowuse U-237228 Apr 2028
US 9999618 listing rowuse U-237328 Apr 2028
US 10383864use U-237116 May 2027
US 10406143use U-237116 May 2027
US 11241422use U-237116 May 2027
US 9000011use U-237116 May 2027
US 9480682use U-237116 May 2027
US 9987263use U-237116 May 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
208623 · 001 · RLDcapsule, oralEQ 123MG BASE11 Jan 2042
Expired or delisted (1)
  • US 8592362 · use U-2371 · 12 Feb 2029 · delisted