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Fentanyl citrate - Generic Drug Details

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Fentanyl citrate is the generic ingredient in nine branded drugs marketed by West-ward Pharms Int, Mallinckrodt, Sentynl Theraps Inc, Par Pharm, Hospira, Watson Labs Inc, Akorn, Abbott, Cephalon, Biodelivery Sci Intl, Depomed Inc, and Watson Labs, and is included in seventeen NDAs. There are eighteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and forty-eight patent family members in thirty-nine countries.

There are thirty-one drug master file entries for fentanyl citrate. Eighteen suppliers are listed for this compound.

Summary for Generic Name: fentanyl citrate

Tradenames:9
Patents:18
Applicants:12
NDAs:17
Drug Master File Entries: see list31
Suppliers / Packaging: see list18
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fentanyl citrate

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-003Jul 16, 2009DISCNNo6,159,498► subscribeY ► subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXNo8,765,100► subscribeY ► subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXNo7,862,833► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: fentanyl citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 19985,785,989► subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-003Nov 4, 19984,863,737► subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 19984,671,953► subscribe
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Non-Orange Book Patents for Generic Ingredient: fentanyl citrate

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
8,802,130Sublingual buccal effervescent► subscribe
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► 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 Ingredient: fentanyl citrate

Country Document Number Estimated Expiration
Canada2629988► subscribe
European Patent Office1417959► subscribe
Australia4488700► 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 CITRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636Luxembourg► subscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0653Netherlands► subscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00714Netherlands► subscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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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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