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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 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 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-one suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for SUBSYS

International Patents:	25
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	26
Clinical Trials:	5
Patent Applications:	4,653
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SUBSYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBSYS
DailyMed Link:	SUBSYS at DailyMed

Pharmacology for SUBSYS

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for SUBSYS

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

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	202788-005	Jan 4, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-007	Aug 30, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		RX	Yes	No			Y
Insys Dev Co Inc	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-007	Aug 30, 2012		RX	Yes	No			Y

Paragraph IV (Patent) Challenges for SUBSYS

Drugname	Dosage	Strength	RLD	Date
	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
	Sublingual Spray	0.4 mg/spray

International Patents for SUBSYS

Country	Document Number	Estimated Expiration
China	101378735
World Intellectual Property Organization (WIPO)	2009017837
Portugal	1976521
Mexico	2008009522
Russian Federation	2432950
Japan	2013056928
Denmark	1976521

Supplementary Protection Certificates for SUBSYS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00016	Denmark		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		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
60030	Netherlands		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
00521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
C/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
00522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006