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Serving leading biopharmaceutical companies globally:

Novartis
Federal Trade Commission
Baxter
Accenture
Teva
Medtronic
Colorcon
Moodys
Cipla
Citi

Generated: January 21, 2018

DrugPatentWatch Database Preview

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 Janssen Pharms, 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mayne Pharma, Mylan Technologies, Noven, Insys Dev Co Inc, Bdsi, Abbott, Hospira, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Akorn, Depomed Inc, Cephalon, Sentynl Theraps Inc, Mallinckrodt, Par Pharm, 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.

There are thirty-one drug master file entries for fentanyl. Twenty-two 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
➤ Subscribe➤ Subscribe100MCGTABLET;BUCCAL
➤ Subscribe➤ Subscribe800MCGTABLET;BUCCAL
➤ Subscribe➤ Subscribe600MCGTABLET;BUCCAL

US Patents and Regulatory Information for fentanyl

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-006 Oct 30, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Depomed Inc LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Actavis Labs Ut Inc FENTANYL-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076709-001 Aug 20, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for fentanyl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for fentanyl

Supplementary Protection Certificates for fentanyl

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0653 Netherlands ➤ Subscribe 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 ➤ Subscribe PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2011000009 Germany ➤ Subscribe PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00521 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2014000024 Germany ➤ Subscribe PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00523 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2014 00016 Denmark ➤ Subscribe 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
00522 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
00653 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2006000022 Germany ➤ Subscribe 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 leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKinsey
Express Scripts
Daiichi Sankyo
Chubb
Boehringer Ingelheim
Deloitte
Dow
Merck

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