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NEXTERONE Drug Profile

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When do Nexterone patents expire, and when can generic versions of Nexterone launch?

Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has forty-five patent family members in twenty countries.

The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for NEXTERONE

International Patents:	45
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	67
Clinical Trials:	2
Patent Applications:	620
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXTERONE
DailyMed Link:	NEXTERONE at DailyMed

Pharmacology for NEXTERONE

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 1A2 Inhibitors

Medical Subject Heading (MeSH) Categories for NEXTERONE

Anti-Arrhythmia Agents

Cytochrome P-450 CYP1A2 Inhibitors

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP2D6 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Potassium Channel Blockers

Sodium Channel Blockers

Vasodilator Agents

Synonyms for NEXTERONE

(2-butyl-1-benzofuran-3-yl)-[4-(2-diethylaminoethyloxy)-3,5-diiodophenyl]methanone hydrochloride

(2-butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone;hydrochloride

(2-Butyl-1-benzofuran-3-yl){4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl}methanone hydrochloride (1:1)

(2-butylbenzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodo-phenyl]methanone hydrochloride

(2-Butylbenzofuran-3-yl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)methanone hydrochloride

{2-[4-(2-butyl-1-benzofuran-3-carbonyl)-2,6-diiodophenoxy]ethyl}diethylamine hydrochloride

19774-82-4

2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride

2-Butyl-3-benzofuranyl 4-[(2-diethylamino)ethoxy] 3,5-diiodophenyl ketone, hydrochloride

2-Butyl-3-benzofuranyl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodo-phenyl]-methanone hydrochloride

2-Butyl-3-benzofuryl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride

51087 N HCl

774A824

976728SY6Z

A 8423

AB0012080

AC-078

AC1L9AZ7

ACT02681

AK149490

AKOS015844018

Ambap19774-82-4

Amio-Aqueous

Amiodar

Amiodarone (hydrochloride)

Amiodarone HCL

Amiodarone hydrochloride

Amiodarone hydrochloride (JP17/USAN)

Amiodarone hydrochloride [JAN]

Amiodarone hydrochloride [USP:JAN]

Amiodarone Hydrochloride 1.0 mg/ml in Methanol (as free base)

Amiodaronum hydrochloride

AN-6656

Ancaron

Ancaron (TN)

Angoron

API0001454

Atlansil

BBC/822

BC207085

BG0032

C25H30ClI2NO3

calcium channel (L type) blocker

CAS-19774-82-4

CC-24084

CCG-39607

CHEBI:2664

CHEMBL1083993

Cordarex

Cordarone (TN)

CPD000058296

CS-1371

D00636

DSSTox_CID_17185

DSSTox_GSID_37185

DSSTox_RID_79304

DTXSID7037185

EINECS 243-293-2

EU-0100122

FT-0083531

FT-0622300

HE072922

HMS1569A20

HSDB 6525

HY-14188

Ketone, 2-butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl, hydrochloride

Ketone,5-diiodophenyl, hydrochloride

KS-5249

L 3428 labaz

LP00122

Methanone, (2-butyl-3-benzofuranyl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)-, hydrochloride (9CI)

Methanone,5-diiodophenyl]-, hydrochloride

MFCD00069204

Miodrone

MLS000028520

MLS001076313

MLS001424272

MLS002222247

MolPort-002-915-715

NC00423

NCGC00015096-12

NCGC00093613-01

NCGC00093613-02

NCGC00093613-03

NCGC00093613-04

NCGC00254295-01

NCGC00260807-01

NSC 85442

NSC-759560

NSC-85442

NSC759560

NSC85442

Opera_ID_568

Pacerone

Pharmakon1600-02300165

PM-101

Prestwick_707

Q-200626

Renodoron

Ritmocardyl

Rythmarone

s1979

SAM001246646

SCHEMBL41348

SK&F-33134-A

SKF 33134 A

SKF 33134-A

SMR000058296

SPECTRUM2300165

TL8001651

Tox21_113478

Tox21_300395

Tox21_500122

Trangorex

UNII-976728SY6Z

W-5062

WLN: T56 BOJ C4 DVR CI EI DO2N2&2 &GH

Z2210825534

ZX-AS005021

US Patents and Regulatory Information for NEXTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008		DISCN	Yes	No			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008		DISCN	Yes	No			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes			Y

Expired US Patents for NEXTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008

International Patents for NEXTERONE

Country	Document Number	Estimated Expiration
Canada	2771879
Japan	2011116776
Japan	2012072160
Japan	4923144
Mexico	2010004900
Canada	2702603
Hong Kong	1219883