Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 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 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, Elefsee Pharms Intl, 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-seven 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

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Recent Clinical Trials for fentanyl citrate

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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

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District Court Litigation
Case NameDate
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-16
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA, Inc.2017-02-03
BioDelivery Sciences International, Inc. v. Teva Pharmaceuticals USA Inc.2016-12-22

See all fentanyl citrate litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

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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
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-005 Oct 30, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 074917-001 Feb 3, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc FENTANYL CITRATE fentanyl citrate TABLET;SUBLINGUAL 207338-005 Nov 17, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 AB RX Yes 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
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011   Start Trial   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011   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
2236132 122015000006 Germany   Start 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
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
2236132 CA 2015 00004 Denmark   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Moodys
McKinsey

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.