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Last Updated: December 13, 2019

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FENTANYL CITRATE - Generic Drug Details

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

Fentanyl citrate is the generic ingredient in nine branded drugs marketed by Bdsi, Abbott, Hospira, Watson Labs, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Akorn, Btcp Pharma, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in nineteen NDAs. There are nineteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has three hundred and thirty-nine patent family members in forty-two countries.

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

Drug Prices for FENTANYL CITRATE

See drug prices for FENTANYL CITRATE

Recent Clinical Trials for FENTANYL CITRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Keith M. Vogt, MD, PhDPhase 4
McGill UniversityPhase 2/Phase 3
The Cooper Health SystemN/A

See all FENTANYL CITRATE clinical trials

Recent Litigation for FENTANYL CITRATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-16
Orexo AB v. Actavis Elizabeth LLC2017-02-28
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-02-03

See all FENTANYL CITRATE litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

See all FENTANYL CITRATE litigation

Pharmacology for FENTANYL CITRATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for FENTANYL CITRATE
2-hydroxypropane-1,2,3-tricarboxylic acid; N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide
437-38-7 (Parent)
990-73-8
990F738
Abstral (TN)
AC1L22J8
AC1Q5SOC
AKOS024457504
AN-48204
API0002694
B5403
CHEBI:31602
CHEMBL688
citric acid; N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide
D01399
DTXSID80243933
EINECS 213-588-0
Fentanyl citrate (JP17/USP)
Fentanyl citrate [USAN:JAN]
Fentanyl citrate [USAN:USP:BAN:JAN]
FENTANYL CITRATE PRESERVATIVE FREE
Fentanyl citrate salt
Fentanyl citrate salt solution, drug standard, 100 mug/mL in methanol: tert-butanol (3:2)
Fentanyl citrate, European Pharmacopoeia (EP) Reference Standard
Fentanyl citrate, United States Pharmacopeia (USP) Reference Standard
Fentanyl dihydrogen citrate
fentanyl monocitrate
Fentaz
Fentora (TN)
FT-0668509
IVLVTNPOHDFFCJ-UHFFFAOYSA-N
Lazanda (TN)
Leptanol
LS-124441
McN-JR 4263
McN-JR-4263-49
MFCD00058359
MUN5LYG46H
N-(1-Phenethyl-4-piperidinyl)propionanilide dihydrogen citrate
N-(1-Phenethyl-4-piperidyl)propionanilide citrate
N-(1-Phenethyl-4-piperidyl)propionanilide citrate (1:1)
N-(1-Phenethyl-4-piperidyl)propionanilide dihydrogen citrate
N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide 2-hydroxypropane-1,2,3-tricarboxylate
N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide citrate
N-(Phenyl)-N-(1-[2-phenylethyl]-4-piperidinyl)propanamide Citrate
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate salt
N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide citrate
N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide 2-hydroxypropane-1,2,3-tricarboxylate
Oralet
Oralet (TN)
Oravescent
Phentanyl citrate
Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
Propionanilide, N-(1-phenethyl-4-piperidyl)-, citrate (1:1)
R 5240
SCHEMBL40733
SUBLIMAZE PRESERVATIVE FREE
UNII-MUN5LYG46H
Paragraph IV (Patent) Challenges for FENTANYL CITRATE
Tradename Dosage Ingredient NDA Submissiondate
ABSTRAL TABLET;SUBLINGUAL fentanyl citrate 022510 2014-06-19
FENTORA TABLET;BUCCAL, SUBLINGUAL fentanyl citrate 021947 2007-11-13
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-12-20
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-11-22
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-10-29
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-10-06

US Patents and Regulatory Information for FENTANYL CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-004 Oct 30, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FENTANYL CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FENTANYL CITRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 CA 2014 00016 Denmark   Start Trial PRODUCT 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
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKesson
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