Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Healthtrust
McKinsey
Medtronic
Boehringer Ingelheim
Argus Health
Merck
Cantor Fitzgerald

Generated: July 16, 2018

DrugPatentWatch Database Preview

Fentanyl citrate - Generic Drug Details

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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. 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
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Elefsee Pharms Intl LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

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 020747-004 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 ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for fentanyl citrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Try a Free Trial
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Try a Free Trial
8,147,866 Transmucosal delivery devices with enhanced uptake ➤ Try a Free Trial
9,655,843 Transmucosal delivery devices with enhanced uptake ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for fentanyl citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00521 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2011000009 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim
McKinsey
Baxter
McKesson
QuintilesIMS

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.