IONSYS Drug Patent Profile

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Which patents cover Ionsys, and what generic alternatives are available?

Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this drug.

This drug has eighty-nine patent family members in eighteen countries.

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.

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Summary for IONSYS

International Patents:	89
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	7
Patent Applications:	3,870
DailyMed Link:	IONSYS at DailyMed

Drug patent expirations by year for IONSYS

Recent Clinical Trials for IONSYS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Medicines Company	Phase 4
Hospital for Special Surgery, New York	Phase 4
The Medicines Company	Phase 3

See all IONSYS clinical trials

US Patents and Regulatory Information for IONSYS

IONSYS is protected by eight US patents.

Patents protecting IONSYS

Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
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Patent Expiration: ⤷ Sign Up

Two-part electrotransport device
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Self-test for analgesic product
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Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Current control for electrotransport drug delivery
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Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Switch validation circuit and method
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Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Self-test for analgesic product
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Method of storing an electrotransport drug delivery device
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Patented Use: METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Switch validation circuit and method
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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for IONSYS

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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	⤷ 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
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

International Patents for IONSYS

See the table below for patents covering IONSYS around the world.

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Country	Patent Number	Title	Estimated Expiration
Ireland	960374		⤷ Sign Up
Portugal	1051220		⤷ Sign Up
Japan	2918262		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013187951		⤷ Sign Up
Canada	2949709	CIRCUIT ET PROCEDE DE VALIDATION PAR COMMUTATION (SWITCH VALIDATION CIRCUIT AND METHOD)	⤷ Sign Up
Russian Federation	2016152271	СХЕМА И СПОСОБ ДЛЯ ПРОВЕРКИ ПЕРЕКЛЮЧАТЕЛЯ	⤷ Sign Up
Luxembourg	91265		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IONSYS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783	CA 2014 00016	Denmark	⤷ Sign Up	PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0383579	C960030	Netherlands	⤷ Sign Up	PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	CA 2006 00019	Denmark	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORID
0975367	122011000009	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description