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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Last Updated: October 14, 2019

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 nine patents protecting this drug and two Paragraph IV challenges.

This drug has thirty patent family members in seventeen countries.

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

Drug patent expirations by year for SUBSYS
Drug Prices for SUBSYS

See drug prices for SUBSYS

Recent Clinical Trials for SUBSYS

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

SponsorPhase
INSYS Therapeutics IncPhase 2
INSYS Therapeutics IncN/A
Loyola UniversityPhase 3

See all SUBSYS clinical trials

Recent Litigation for SUBSYS

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

See all SUBSYS litigation

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

See all SUBSYS litigation

Pharmacology for SUBSYS
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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)
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]
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 (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 202788-005 Jan 4, 2012 RX Yes No   See Pricing   See Pricing Y   See Pricing
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No   See Pricing   See Pricing Y   See Pricing
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   See Pricing   See Pricing Y   See Pricing
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No   See Pricing   See Pricing Y   See Pricing
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   See Pricing   See Pricing   See Pricing
Insys Dev Co Inc SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
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   See Pricing
➤ Subscribe Sublingual Spray 0.4 mg/spray ➤ Subscribe   See Pricing

Supplementary Protection Certificates for SUBSYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 122006000022 Germany   See Pricing PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0383579 C960030 Netherlands   See Pricing 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
1635783 CA 2014 00016 Denmark   See Pricing 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
0836511 SPC/GB06/022 United Kingdom   See Pricing PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 122014000024 Germany   See Pricing PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783 C300653 Netherlands   See Pricing 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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