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Last Updated: December 14, 2019

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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 Btcp Pharma and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-one patent family members in seventeen countries.

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

US ANDA Litigation and Generic Entry Outlook for Subsys

Subsys was eligible for patent challenges on December 31st, 1968.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

There is one tentative approval for the generic drug (fentanyl), which indicates the potential for near-term generic launch.

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
Paragraph IV (Patent) Challenges for SUBSYS
Tradename Dosage Ingredient NDA Submissiondate
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-12-07
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-05-22

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
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 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

Supplementary Protection Certificates for SUBSYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0383579 C960030 Netherlands   Start Trial 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
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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
1635783 CA 2014 00016 Denmark   Start 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
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783 C300653 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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