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Last Updated: April 1, 2026

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 seven 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:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021338

Generic Entry Date for 021338^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 9,364,656 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYSTEM;IONTOPHORESIS, TRANSDERMAL			Strength	EQ 40MCG BASE/ACTIVATION
Approval Date:	May 22, 2006	TE:		RLD:	Yes
Patent:	8,301,238	Patent Expiration:	Sep 30, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,428,708	Patent Expiration:	May 21, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
Patent:	8,428,709	Patent Expiration:	Jun 11, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Expired US Patents for NDA 021338

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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	6,216,033	⤷ Start Trial
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	6,975,902	⤷ Start Trial
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	5,232,438	⤷ Start Trial
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	6,169,920	⤷ Start Trial
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	6,425,892	⤷ Start Trial
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	6,881,208	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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