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Serving 500+ biopharmaceutical companies globally:

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Generated: July 27, 2017

DrugPatentWatch Database Preview

Fentanyl - Generic Drug Details

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What are the generic sources for fentanyl and what is the scope of fentanyl patent protection?

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, Mayne Pharma, Noven, Insys Dev Co Inc, 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-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has twenty-two patent family members in fifteen 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:39
Applicants:23
NDAs:28
Drug Master File Entries: see list31
Suppliers / Packagers: see list23
Bulk Api Vendors: see list21
Clinical Trials: see list825
Patent Applications: see list2,827
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. Strength Dosage Form
► Subscribe► Subscribe100MCGTABLET;BUCCAL
► Subscribe► Subscribe800MCGTABLET;BUCCAL
► Subscribe► Subscribe600MCGTABLET;BUCCAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Insys Dev Co Inc
SUBSYS
fentanyl
SPRAY;SUBLINGUAL202788-003Jan 4, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-001Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
The Medicines Co
IONSYS
fentanyl hydrochloride
SYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► 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-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-004Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-002Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-001Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-001Aug 7, 1990► Subscribe► Subscribe
Janssen Pharms
DURAGESIC-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL019813-003Aug 7, 1990► Subscribe► Subscribe
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International Patent Family for Ingredient: fentanyl

Country Document Number Estimated Expiration
European Patent Office1976521► Subscribe
Japan2013127003► Subscribe
Russian Federation2008130763► Subscribe
Russian Federation2432950► Subscribe
Cyprus1117263► 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
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG 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
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Accenture
Cipla
Moodys
QuintilesIMS
Daiichi Sankyo
UBS
Johnson and Johnson
McKinsey
Fish and Richardson

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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