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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Moodys
Farmers Insurance
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Queensland Health
Daiichi Sankyo
Argus Health
Novartis

Generated: October 23, 2017

DrugPatentWatch Database Preview

IONSYS Drug Profile

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Which patents cover Ionsys, and when can generic versions of Ionsys launch?

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

This drug has one hundred and eighty-six patent family members in thirty-four countries and ten supplementary protection certificates in four countries.

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 Tradename: IONSYS

US Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list20
Clinical Trials: see list6
Patent Applications: see list53
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:IONSYS at DailyMed

Pharmacology for Tradename: IONSYS

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: IONSYS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: IONSYS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,090,095 Electrotransport delivery device► Subscribe
9,645,179Self-test for analgesic product► Subscribe
6,505,069 Electrochemically reactive cathodes for an electrotransport device► Subscribe
6,317,629 Iontophoretic drug delivery apparatus► Subscribe
7,054,683Methods of electrotransport drug delivery► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: IONSYS

Country Document Number Estimated Expiration
South Africa9303819► Subscribe
World Intellectual Property Organization (WIPO)2012134766► Subscribe
World Intellectual Property Organization (WIPO)9617651► Subscribe
World Intellectual Property Organization (WIPO)2004002571► Subscribe
Russian Federation2014151720► Subscribe
Japan2002513596► Subscribe
European Patent Office2858715► Subscribe
Canada2134351► Subscribe
Greece960100178► Subscribe
Denmark1051220► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: IONSYS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2014 00016Denmark► SubscribePRODUCT 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
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
UBS
Federal Trade Commission
Express Scripts
Deloitte
Harvard Business School
US Army
Cantor Fitzgerald
Argus Health
QuintilesIMS

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. thinkBiotech performs no independent verifification 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.

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