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Generated: August 22, 2019

DrugPatentWatch Database Preview

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. It is available from one supplier. There are eleven 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. One supplier is listed 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:11
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021338
Generic Entry Date for 021338*:
Constraining patent/regulatory exclusivity:
Dosage:
SYSTEM;IONTOPHORESIS, TRANSDERMAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021338
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 021338
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338 NDA The Medicines Company 65293-011 65293-011-06 6 TRAY in 1 CARTON (65293-011-06) > 1 POUCH in 1 TRAY (65293-011-01) > 1 PATCH in 1 POUCH

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:Nov 2, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Patent:➤ Sign UpPatent Expiration:Apr 19, 2022Product 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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