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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. Seventeen 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 / Packagers: see list17
Bulk Api Vendors: see list16
Clinical Trials: see list555
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
Watson Labs
FENTANYL CITRATE
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL079075-003Jan 7, 2011DISCNNo► subscribe► subscribe
Depomed Inc
LAZANDA
fentanyl citrate
SPRAY, METERED;NASAL022569-002Jun 30, 2011RXYes8,889,176► subscribe ► 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
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-003Jul 16, 20096,159,498► subscribe
Cephalon
FENTANYL
fentanyl citrate
TROCHE/LOZENGE;ORAL020195-001Oct 4, 19934,671,953► subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-002Nov 4, 19984,863,737► 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
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► subscribe
6,350,470 Effervescent drug delivery system for oral administration► subscribe
8,802,130Sublingual buccal effervescent► 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
European Patent Office1635783► subscribe
Japan5685610► subscribe
China1723012► 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
0653Netherlands► subscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2015 00004Denmark► subscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
00522Netherlands► subscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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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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