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Serving leading biopharmaceutical companies globally:

Queensland Health
Chubb
Chinese Patent Office
Moodys
McKesson
AstraZeneca
Boehringer Ingelheim
Citi
Cantor Fitzgerald
Teva

Generated: January 23, 2018

DrugPatentWatch Database Preview

FENTORA Drug Profile

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When do Fentora patents expire, and when can generic versions of Fentora launch?

Fentora is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-nine patent family members in twenty-seven countries.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for FENTORA
Drug patent expirations by year for FENTORA
Pharmacology for FENTORA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for FENTORA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-006 Mar 2, 2007 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ 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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Paragraph IV (Patent) Challenges for FENTORA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe 11/13/2007

Non-Orange Book US Patents for FENTORA

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
8,298,577 Effervescent oral opiate dosage forms and methods of administering opiates ➤ Subscribe
6,350,470 Effervescent drug delivery system for oral administration ➤ Subscribe
7,858,121 Effervescent oral fentanyl dosage form and methods of administering fentanyl ➤ Subscribe
8,802,130 Sublingual buccal effervescent ➤ Subscribe
6,641,838 Effervescent drug delivery system for oral administration ➤ Subscribe
6,764,696 Effervescent drug delivery system for oral administration ➤ Subscribe
6,391,335 Effervescent drug delivery system for oral administration ➤ Subscribe
6,509,036 Effervescent drug delivery system for oral administration ➤ Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for FENTORA

Supplementary Protection Certificates for FENTORA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00521 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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
2011000009 Germany ➤ Subscribe PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00653 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0653 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
C/GB06/022 United Kingdom ➤ Subscribe PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2014000024 Germany ➤ Subscribe PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00522 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fuji
Argus Health
Deloitte
Fish and Richardson
US Department of Justice
McKesson
Citi
Cerilliant
Covington

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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