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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Novartis
Harvard Business School
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Cerilliant
McKesson
Baxter
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Generated: September 20, 2017

DrugPatentWatch Database Preview

SUBSYS Drug Profile

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What is the patent landscape for Subsys, and when can generic versions of Subsys launch?

Subsys is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in fifteen countries.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for Tradename: SUBSYS

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list21
Clinical Trials: see list5
Patent Applications: see list6,490
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SUBSYS at DailyMed

Pharmacology for Tradename: SUBSYS

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
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-006Aug 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-004Jan 4, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-007Aug 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-006Aug 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-007Aug 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-007Aug 30, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-004Jan 4, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-005Jan 4, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-004Jan 4, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-001Jan 4, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV activity for: SUBSYS

Drugname Dosage Strength RLD Submissiondate
fentanylSublingual Spray0.4 mg/spraySubsys5/22/2017

International Patent Family for Tradename: SUBSYS

Country Document Number Estimated Expiration
Japan2013056928► Subscribe
Denmark1976521► Subscribe
World Intellectual Property Organization (WIPO)2009017837► Subscribe
Spain2535233► Subscribe
Russian Federation2008130763► Subscribe
Japan5241514► Subscribe
Japan2013127003► Subscribe
Russian Federation2432950► Subscribe
Japan2009528272► Subscribe
Portugal1976521► 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.

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Supplementary Protection Certificates for Tradename: SUBSYS

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

Serving 500+ biopharmaceutical companies globally:

Novartis
Moodys
Boehringer Ingelheim
McKesson
Merck
Queensland Health
Baxter
Colorcon
US Army
Julphar

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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