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Serving leading biopharmaceutical companies globally:

Argus Health
Merck
Accenture
Fuji
McKesson
Boehringer Ingelheim
QuintilesIMS
Mallinckrodt
Cantor Fitzgerald
AstraZeneca

Generated: November 20, 2017

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Fentanyl - Generic Drug Details

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What are the generic sources for fentanyl and what is the scope of fentanyl patent protection?

Fentanyl
is the generic ingredient in twenty-four branded drugs marketed by Actavis Labs Ut Inc, Janssen Pharms, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mylan Technologies, Mayne Pharma, Noven, Insys Dev Co Inc, 3m Drug Delivery, West-ward Pharms Int, Mallinckrodt, Sentynl Theraps Inc, Par Pharm, Hospira, Watson Labs Inc, Akorn, Abbott, Cephalon, Bdsi, Depomed Inc, Watson Labs, and The Medicines Co, and is included in twenty-eight NDAs. There are forty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has twenty-five patent family members in fifteen countries and ten supplementary protection certificates in four countries.

There are thirty-one drug master file entries for fentanyl. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for fentanyl

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for fentanyl

Tentative approvals for FENTANYL

Applicant Application No. Strength Dosage Form
u► Subscribe100MCGTABLET;BUCCAL
u► Subscribe800MCGTABLET;BUCCAL
u► Subscribe600MCGTABLET;BUCCAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
LAZANDA
fentanyl citrate
SPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
FENTANYL-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077154-003Feb 9, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Technologies
FENTANYL-12
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL076258-005Jan 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
FENTANYL CITRATE
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL077312-002Oct 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-004Jan 4, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
3m Drug Delivery
FENTANYL-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL202097-004Nov 4, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fentanyl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-001Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-003Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-003Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-003Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 1990► Subscribe► Subscribe
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International Patent Family for Ingredient: fentanyl

Country Document Number Estimated Expiration
Russian Federation2008130763► Subscribe
Slovenia1976521► Subscribe
Portugal1976521► Subscribe
Japan2009528272► Subscribe
BrazilPI0707235► Subscribe
World Intellectual Property Organization (WIPO)2009017837► Subscribe
European Patent Office2180844► Subscribe
Mexico2008009522► Subscribe
Japan2013127003► Subscribe
Japan2013056928► 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: FENTANYL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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
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
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2014000024Germany► 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
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Serving leading biopharmaceutical companies globally:

Teva
Colorcon
Dow
Covington
Johnson and Johnson
Novartis
Julphar
Federal Trade Commission
Express Scripts
Merck

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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