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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Healthtrust
Fuji
Cantor Fitzgerald
Farmers Insurance
Baxter
Dow
QuintilesIMS
Medtronic

Generated: August 15, 2018

DrugPatentWatch Database Preview

SUBSYS Drug Profile

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

Subsys is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in fifteen countries.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Drug patent expirations by year for SUBSYS
Pharmacology for SUBSYS
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for SUBSYS
Synonyms for SUBSYS
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]
Fentora
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 (TN)
Tox21_112611
UF599785JZ
UNII-UF599785JZ
ZINC2522669

US Patents and Regulatory Information for SUBSYS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 SUBSYS
Drugname Dosage Strength RLD Date
➤ Subscribe Sublingual Spray 0.1 mg/spray,0.2 mg/spray,0.6 mg/spray,0.8 mg/spray,1.2 mg/spray,1.6 mg/spray ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Spray 0.4 mg/spray ➤ Subscribe ➤ Try a Free Trial

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International Patents for SUBSYS

Supplementary Protection Certificates for SUBSYS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00521 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
C/GB06/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2014 00016 Denmark ➤ Try a Free 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
00653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Queensland Health
Farmers Insurance
Dow
Fish and Richardson
Healthtrust
Teva
Cerilliant

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