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Serving leading biopharmaceutical companies globally:

US Department of Justice
Deloitte
Federal Trade Commission
Dow
McKesson
Cipla
Boehringer Ingelheim
QuintilesIMS
Fish and Richardson
UBS

Generated: February 18, 2018

DrugPatentWatch Database Preview

SUBSYS Drug Profile

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When do Subsys patents expire, 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 two Paragraph IV challenges.

This drug has twenty-five 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-one suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Drug patent expirations by year for SUBSYS
Pharmacology for SUBSYS
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for SUBSYS

US Patents and Regulatory Information for SUBSYS

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;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SUBSYS
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Sublingual Spray 0.1 mg/spray,0.2 mg/spray,0.6 mg/spray,0.8 mg/spray,1.2 mg/spray,1.6 mg/spray ➤ Subscribe 12/7/2017
➤ Subscribe Sublingual Spray 0.4 mg/spray ➤ Subscribe 5/22/2017

International Patents for SUBSYS

Supplementary Protection Certificates for SUBSYS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 00019 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORID
2011000009 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2014000024 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2014 00016 Denmark ➤ Try a Free Trial 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
00521 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB06/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
00523 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2006000022 Germany ➤ Try a Free Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Harvard Business School
Federal Trade Commission
Julphar
Accenture
Boehringer Ingelheim
US Department of Justice
Cerilliant
Moodys

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