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IONSYS Drug Profile

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Which patents cover Ionsys, and when can generic versions of Ionsys launch?

Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and sixty-eight patent family members in thirty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Ionsys

Ionsys was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

Summary for IONSYS

International Patents:	168
US Patents:	11
Applicants:	1
NDAs:	1
Bulk Api Vendors:	27
Clinical Trials:	6
Patent Applications:	7,085
Formulation / Manufacturing:	see details
DailyMed Link:	IONSYS at DailyMed

Recent Clinical Trials for IONSYS

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

Sponsor	Phase
The Medicines Company	Phase 4
Hospital for Special Surgery, New York	Phase 4
Alza Corporation, DE, USA	Phase 3

See all IONSYS clinical trials

Synonyms for IONSYS

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

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 IONSYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y

Expired US Patents for IONSYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006

International Patents for IONSYS

Country	Patent Number	Estimated Expiration
Mexico	2013010199
Italy	TO960477
India	10505DEN2014
Japan	6027089

Supplementary Protection Certificates for IONSYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831