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Generated: May 20, 2019

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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 one hundred patent family members in twenty-eight countries.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Thirteen 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)
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
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]
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

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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ➤ 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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Expired US Patents for FENTORA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FENTORA
Drugname Dosage Strength RLD Date
➤ Subscribe Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for FENTORA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 CA 2014 00016 Denmark ➤ Sign Up 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
1635783 C300653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783 300653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0383579 C960030 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
1769785 C300522 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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