Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021348

✉ Email this page to a colleague

NDA 021348 describes ZAVESCA, which is a drug marketed by Actelion and is included in one NDA. It is available from two suppliers. Additional details are available on the ZAVESCA profile page.

The generic ingredient in ZAVESCA is miglustat. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the miglustat profile page.

Summary for 021348

Tradename:	ZAVESCA
Applicant:	Actelion
Ingredient:	miglustat
Patents:	0

Pharmacology for NDA: 021348

Mechanism of Action	Glucosylceramide Synthase Inhibitors

Suppliers and Packaging for NDA: 021348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZAVESCA	miglustat	CAPSULE;ORAL	021348	NDA AUTHORIZED GENERIC	CoTherix, Inc.	10148-201	10148-201-90	6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15)
ZAVESCA	miglustat	CAPSULE;ORAL	021348	NDA	Actelion Pharmaceuticals US, Inc.	66215-201	66215-201-90	6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 31, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021348

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	5,472,969	⤷ Start Trial
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	5,525,616	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.