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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 twelve patents protecting this drug.

This drug has one hundred and seventy-five 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. One supplier is listed for this compound. Additional details are available on the fentanyl hydrochloride profile page.

Summary for IONSYS

International Patents:	175
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	26
Clinical Trials:	6
Patent Applications:	4,603
Formulation / Manufacturing:	see details
DailyMed Link:	IONSYS at DailyMed

Generic Entry Opportunity Date for IONSYS

NDA:

021338

Dosage:

SYSTEM;IONTOPHORESIS, TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for IONSYS

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

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)

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

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

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			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

International Patents for IONSYS

Country	Document Number	Estimated Expiration
Sweden	9704103
Australia	2013274873
China	1170604

Supplementary Protection Certificates for IONSYS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID