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Fentanyl - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fentanyl?

Fentanyl is the generic ingredient in twenty-four branded drugs marketed by Actavis Labs Ut Inc, Janssen Pharms, Aveva, Lavipharm Labs, Mallinckrodt Inc, Mylan Technologies, Par Pharm Inc, Noven, Insys Therap, 3m Drug Delivery, West-ward Pharms Int, Mallinckrodt, Sentynl Theraps Inc, Par Pharm, Hospira, Watson Labs Inc, Akorn, Abbott, Cephalon, Bdsi, Depomed Inc, Watson Labs, and The Medicines Co, and is included in twenty-eight NDAs. There are thirty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl has twenty-one patent family members in fourteen countries.

There are thirty-one drug master file entries for fentanyl. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fentanyl

Tradenames:24
Patents:36
Applicants:23
NDAs:28
Drug Master File Entries: see list31
Suppliers / Packagers: see list23
Bulk Api Vendors: see list21
Clinical Trials: see list354
Patent Applications: see list19,146
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fentanyl at DailyMed

Pharmacology for Ingredient: fentanyl

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for FENTANYL

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;BUCCAL100MCG
► Subscribe► SubscribeTABLET;BUCCAL200MCG
► Subscribe► SubscribeTABLET;BUCCAL300MCG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aveva
FENTANYL-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077449-003Oct 20, 2008RXNoNo► Subscribe► Subscribe
Par Pharm Inc
FENTANYL-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077062-001Aug 20, 2007RXNoNo► Subscribe► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-005Jul 16, 2009DISCNNoNo7,579,019► Subscribe ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes8,781,571► SubscribeY ► Subscribe
Mallinckrodt Inc
FENTANYL-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077154-004Feb 9, 2011RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fentanyl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 19904,588,580*PED► Subscribe
Janssen Pharms
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-001Aug 7, 19904,060,084► Subscribe
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 19904,060,084► Subscribe
Janssen Pharms
DURAGESIC-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 19904,588,580*PED► Subscribe
Janssen Pharms
DURAGESIC-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-003Aug 7, 19904,588,580*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fentanyl

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
9,289,387Method of treating pain by administering sublingual fentanyl spray► 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

Country Document Number Estimated Expiration
Japan2009528272► Subscribe
Mexico2008009522► Subscribe
Australia2008282743► Subscribe
European Patent Office1976521► Subscribe
Slovenia1976521► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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
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
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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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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