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Generated: October 20, 2018

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Fentanyl citrate - Generic Drug Details

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

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

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

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; FENTANYL
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, United States Pharmacopeia (USP) Reference Standard
Fentanyl dihydrogen citrate
fentanyl monocitrate
Fentanylcitrate
Fentaz
Fentora (TN)
FT-0668509
HE071150
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 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

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
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-004 Oct 30, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 072786-001 Sep 24, 1991 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Fl Inc FENTANYL CITRATE fentanyl citrate TABLET;SUBLINGUAL 207338-004 Nov 17, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 020747-001 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Elefsee Pharms Intl LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-007 Oct 30, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for fentanyl citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000006 Germany ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2006000022 Germany ➤ Try a Free Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
2014 00016 Denmark ➤ Try a Free 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
2015 00004 Denmark ➤ Try a Free Trial PRODUCT 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
2006 00019 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORID
00522 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Baxter
US Army
Merck
UBS
Boehringer Ingelheim
Citi
Mallinckrodt

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