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FDA Orange Book · active-ingredient family

Migalastat hydrochloride

Migalastat hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:GALAFOLD · NDA 208623

1

Brand (NDA)

0

Generics (ANDA)

66

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
GALAFOLDRLDAMICUS THERAP USNDA 208623—Aug 10, 2018

Listed patents (66)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9987263May 16, 2027in 11 mo
U-2371
9480682May 16, 2027in 11 mo
U-2371
9000011May 16, 2027in 11 mo
U-2371
10383864May 16, 2027in 11 mo
U-2371
10406143May 16, 2027in 11 mo
U-2371
11241422May 16, 2027in 11 mo
U-2371
9999618Apr 28, 2028in 1 yr 11 mo
U-2373
10525045Apr 28, 2028in 1 yr 11 mo
U-2371
11033538Apr 28, 2028in 1 yr 11 mo
U-2371
10925866Apr 28, 2028in 1 yr 11 mo
U-2371
12599595Apr 28, 2028in 1 yr 11 mo
U-2371
9095584Feb 12, 2029in 2 yr 8 mo
U-2371
8592362Feb 12, 2029in 2 yr 8 mo
U-2371Delisted
10813921Feb 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
12280042May 30, 2038in 12 yr 1 mo
SubstanceU-2371
12042490May 30, 2038in 12 yr 1 mo
U-2371
12042489May 30, 2038in 12 yr 1 mo
SubstanceU-2371
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
11458128May 30, 2038in 12 yr 1 mo
U-2371
11666564May 30, 2038in 12 yr 1 mo
U-2371
12109205May 30, 2038in 12 yr 1 mo
SubstanceU-2371
10857141May 30, 2038in 12 yr 1 mo
U-2371
10849890May 30, 2038in 12 yr 1 mo
U-2371
10849889May 30, 2038in 12 yr 1 mo
U-2371
10857142May 30, 2038in 12 yr 1 mo
U-2371
10874657May 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
11389437May 30, 2038in 12 yr 1 mo
U-2371
11389436May 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
11813255May 30, 2038in 12 yr 1 mo
U-2371
11278538May 30, 2038in 12 yr 1 mo
U-2371
11278537May 30, 2038in 12 yr 1 mo
U-2371
11278536May 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
11612594May 30, 2038in 12 yr 1 mo
Substance
12042488May 30, 2038in 12 yr 1 mo
Substance
11357764May 30, 2038in 12 yr 1 mo
Substance
11376244May 30, 2038in 12 yr 1 mo
Substance
11612593May 30, 2038in 12 yr 1 mo
Substance
11357765May 30, 2038in 12 yr 1 mo
Substance
11426396May 30, 2038in 12 yr 1 mo
Substance
11633387May 30, 2038in 12 yr 1 mo
Substance
11786516May 30, 2038in 12 yr 1 mo
Substance
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

Migalastat hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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

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