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Generated: March 20, 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 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.

Fentanyl citrate has three hundred and fifty-seven patent family members in forty-one countries.

There are thirty-one drug master file entries for fentanyl citrate. Thirteen 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; 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

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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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
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
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-006 Oct 30, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Fl Inc FENTANYL CITRATE fentanyl citrate TABLET;SUBLINGUAL 207338-005 Nov 17, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 020747-003 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 ➤ 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 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 022266-001 Jul 16, 2009 ➤ 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 CA 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
2236132 C300714 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
0975367 122011000009 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2236132 92636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0836511 SPC/GB06/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2236132 484 Finland ➤ Try a Free Trial
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Harvard Business School

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