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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Farmers Insurance
Boehringer Ingelheim
US Army
Queensland Health
QuintilesIMS
Cerilliant
McKinsey
Chubb

Generated: November 19, 2017

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FENTORA Drug Profile

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What is the patent landscape for Fentora, 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 one hundred patent family members in twenty-seven countries and ten supplementary protection certificates in four countries.

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

Pharmacology for FENTORA

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
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-001Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-006Mar 2, 2007DISCNYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for FENTORA

Drugname Dosage Strength RLD Submissiondate
fentanyl citrateBuccal Tablets0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mgFentora11/13/2007

Non-Orange Book Patents for Tradename: 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
8,802,130Sublingual buccal effervescent► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,509,036 Effervescent drug delivery system for oral administration► Subscribe
6,391,335 Effervescent drug delivery system for oral administration► Subscribe
6,641,838 Effervescent drug delivery system for oral administration► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FENTORA

Country Document Number Estimated Expiration
Austria434432► Subscribe
Argentina048029► Subscribe
Japan4954170► Subscribe
Denmark1417959► Subscribe
BrazilPI0418213► Subscribe
Australia2004311879► Subscribe
TaiwanI354551► Subscribe
Taiwan200611696► Subscribe
Argentina048000► Subscribe
European Patent Office1708686► 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: FENTORA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION 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
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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Serving leading biopharmaceutical companies globally:

Medtronic
Teva
Healthtrust
Fuji
Merck
Colorcon
Daiichi Sankyo
Chubb
Cipla
Moodys

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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