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:

Medtronic
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Harvard Business School
Boehringer Ingelheim
Express Scripts

Last Updated: December 6, 2019

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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 freedom to operate?

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-eight 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
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
Hospira FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 072786-001 Sep 24, 1991 AP RX No No   Start Trial   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes   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 022510-003 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 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
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Express Scripts
Dow
Johnson and Johnson
Colorcon

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.