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FENTORA Drug Profile

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

This drug has eighty-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. Seventeen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for Tradename: FENTORA

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list20
Clinical Trials: see list3
Patent Applications: see list11,505
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FENTORA at DailyMed

Pharmacology for Tradename: FENTORA

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo8,753,611► subscribe ► subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo8,753,611► subscribe ► subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo8,092,832► subscribeY ► subscribe
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Paragraph IV activity 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
6,350,470 Effervescent drug delivery system for oral administration► subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal 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
Cyprus1107592► subscribe
Cyprus1109176► subscribe
BrazilPI0418228► 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
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
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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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