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Generated: May 29, 2017

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Fentanyl - Generic Drug Details

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

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 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-seven 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

Drug Master File Entries: see list31
Suppliers / Packagers: see list23
Bulk Api Vendors: see list21
Clinical Trials: see list354
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
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo8,765,100► SubscribeY ► Subscribe
fentanyl citrate
FILM;BUCCAL022266-003Jul 16, 2009DISCNNoNo7,579,019► Subscribe ► Subscribe
Lavipharm Labs
FILM, EXTENDED RELEASE;TRANSDERMAL077051-001Aug 4, 2006ABRXNoNo► Subscribe► Subscribe
Sentynl Theraps Inc
fentanyl citrate
TABLET;SUBLINGUAL022510-004Jan 7, 2011RXYesYes6,759,059► SubscribeY ► Subscribe
Insys Therap
SPRAY;SUBLINGUAL202788-001Jan 4, 2012RXYesNo9,241,935► SubscribeY ► Subscribe
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