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Last Updated: October 24, 2019

DrugPatentWatch Database Preview

Fentanyl - Generic Drug Details

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

Fentanyl is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Insys Dev Co Inc, 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 The Medicines Co, and is included in thirty NDAs. There are thirty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has thirty patent family members in seventeen countries.

There are thirty-one drug master file entries for fentanyl. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for fentanyl

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Drug Sales Revenue Trends for fentanyl

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Recent Clinical Trials for fentanyl

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Helse FonnaPhase 4
University Hospital, AkershusN/A
University of CopenhagenPhase 4

See all fentanyl clinical trials

Recent Litigation for fentanyl

Identify potential future generic entrants

District Court Litigation
Case NameDate
Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.2018-08-23
Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.2017-09-13
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2013-05-17

See all fentanyl litigation

PTAB Litigation
PetitionerDate
Coalition For Affordable Drugs XI LLC2015-08-24
Coalition For Affordable Drugs XI LLC2015-08-24

See all fentanyl litigation

Generic filers with tentative approvals for FENTANYL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MCGTABLET;BUCCAL
  Start Trial  Start Trial800MCGTABLET;BUCCAL
  Start Trial  Start Trial600MCGTABLET;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fentanyl
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for fentanyl
Synonyms for fentanyl
1-(2-Phenylethyl)-4-(N-propananilido)piperidine
1-Phenethyl-4-(N-phenylpropionamido)piperidine
1-Phenethyl-4-N-propionylanilinopiperidine
437-38-7
5-22-08-00049 (Beilstein Handbook Reference)
80832-90-2
9235-EP2275420A1
9235-EP2277861A1
9235-EP2277875A2
9235-EP2280008A2
9235-EP2298764A1
9235-EP2298765A1
9235-EP2298768A1
9235-EP2305652A2
9235-EP2305654A1
9235-EP2308509A1
9235-EP2308872A1
9235-EP2314585A1
9235-EP2314590A1
9235-EP2316829A1
990-73-8 (citrate)
AC1L1FQ2
ACN-S001735
API0002693
BDBM50008984
BIDD:GT0555
BRN 0494484
CAS-437-38-7
CF0052
CHEBI:119915
CHEMBL596
CS-7211
CTK8G2863
D00320
DB00813
DSSTox_CID_3049
DSSTox_GSID_23049
DSSTox_RID_76851
DTXSID9023049
Duragesic
Duragesic (TN)
Duragesic-100
Duragesic-12
Duragesic-25
Duragesic-50
Duragesic-75
Durogesic
Durotep MT
effentora
EINECS 207-113-6
Epitope ID:153507
Fentanest
Fentanil
Fentanil [DCIT]
Fentanila
Fentanila [INN-Spanish]
Fentanilo
Fentanyl (JAN/USAN/INN)
Fentanyl [INN:BAN]
Fentanyl [USAN:USP:INN:BAN]
Fentanyl 0.1 mg/ml in Methanol
Fentanyl 1.0 mg/ml in Methanol
Fentanyl buccal
Fentanyl CII
Fentanyl solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Fentanyl solution, 100 mug/mL in methanol, ampule of 1 mL, certified reference material
Fentanyl Transdermal System
Fentanyl-100
Fentanyl-12
Fentanyl-25
Fentanyl-50
Fentanyl-75
FENTANYL-HCl
Fentanylum
Fentanylum [INN-Latin]
Fentora
FT-0668508
GTPL1626
HSDB 3329
HY-U00158
IONSYS
JNS020QD
L001275
LS-124439
Matrifen
N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenylpropanamide
N-(1-Phenethyl-4-piperidinyl)-N-phenylpropionamide
N-(1-Phenethyl-4-piperidyl)propionanilide
N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide
N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide(Fentanyl)
N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide
N-(1-Phenethylpiperidin-4-yl)-N-phenylpropionamide
N-(1-Phenylethyl-4-piperidinyl)propionanilide
N-Phenethyl-4-(N-propionylanilino)piperidine
N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide
N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide #
N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide
NCGC00168252-01
Oprea1_152073
Oprea1_207148
PDSP1_000860
PDSP2_000846
PecFent
Phentanyl
PJMPHNIQZUBGLI-UHFFFAOYSA-N
Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-
Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)- (9CI)
Propanamide, N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]-
Propionanilide, N-(1-phenethyl-4-piperidyl)-
R 4263
R4263
SCHEMBL8804
Sentonil
Sublimase
Sublimaze
Subsys
Subsys (TN)
Tox21_112611
UF599785JZ
UNII-UF599785JZ
ZINC2522669
Paragraph IV (Patent) Challenges for FENTANYL
Tradename Dosage Ingredient NDA Submissiondate
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-12-07
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-05-22
DURAGESIC-100 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-50 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-12 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-75 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-25 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-37 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813

US Patents and Regulatory Information for fentanyl

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fentanyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0975367 122011000009 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783 300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
Colorcon
McKesson
Dow

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.