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Miglustat - Generic Drug Details

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Miglustat is the generic ingredient in one branded drug marketed by Actelion Pharms Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for miglustat. One supplier is listed for this compound.

Summary for Generic Name: miglustat

Tradenames:1
Patents:0
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packaging: see list1
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details

Pharmacology for Ingredient: miglustat

Clinical Trials for: miglustat

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
ZAVESCA
miglustat
CAPSULE;ORAL021348-001Jul 31, 2003RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: miglustat

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd
ZAVESCA
miglustat
CAPSULE;ORAL021348-001Jul 31, 20035,472,969<disabled>
Actelion Pharms Ltd
ZAVESCA
miglustat
CAPSULE;ORAL021348-001Jul 31, 20035,525,616<disabled>
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