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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021338


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NDA 021338 describes IONSYS, which is a drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this drug. Additional details are available on the IONSYS profile page.

The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the fentanyl hydrochloride profile page.
Summary for 021338
Tradename:IONSYS
Applicant:The Medicines Co
Ingredient:fentanyl hydrochloride
Patents:8

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYSTEM;IONTOPHORESIS, TRANSDERMALStrengthEQ 40MCG BASE/ACTIVATION
Approval Date:May 22, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 30, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 21, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Expired US Patents for NDA 021338

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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