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Accenture
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US Department of Justice
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Daiichi Sankyo
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McKinsey
Citi
Cantor Fitzgerald

Generated: May 26, 2018

DrugPatentWatch Database Preview

FENTORA Drug Profile

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When do Fentora patents expire, and when can generic versions of Fentora launch?

Fentora is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-nine patent family members in twenty-seven countries.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Drug patent expirations by year for FENTORA
Pharmacology for FENTORA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for FENTORA
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)
Abstral
AC1L1FQ2
ACN-S001735
Actiq
AK116449
API0002693
BDBM50008984
BIDD:GT0555
BRN 0494484
CAS-437-38-7
CF0052
CHEBI:119915
CHEMBL596
CS-7211
CTK8G2863
D00320
D09ISU
D0E1WI
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
Fentanyl (JAN/USAN/INN)
fentanyl (transmucosal film, pain), Auxilium Pharmaceuticals
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-37
Fentanyl-50
Fentanyl-62
Fentanyl-75
Fentanyl-87
FENTANYL-HCl
Fentanylum
Fentanylum [INN-Latin]
FT-0668508
GTPL1626
HE006416
HE343370
HE343371
HSDB 3329
HY-U00158
Instanyl
IONSYS
JNS020QD
L001275
Lazanda
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
pain therapy (transmucosal film), Auxilium Pharmaceuticals
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

US Patents and Regulatory Information for FENTORA

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 021947-005 Sep 25, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for FENTORA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe 2007-11-13

Non-Orange Book US Patents for FENTORA

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
8,802,130 Sublingual buccal effervescent ➤ Sign Up
6,509,036 Effervescent drug delivery system for oral administration ➤ Sign Up
6,350,470 Effervescent drug delivery system for oral administration ➤ Sign Up
8,298,577 Effervescent oral opiate dosage forms and methods of administering opiates ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for FENTORA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00522 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2014000024 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00521 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
60030 Netherlands ➤ Sign Up PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Fish and Richardson
Healthtrust
Boehringer Ingelheim
Teva
AstraZeneca
Argus Health
Cantor Fitzgerald
Farmers Insurance

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