Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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Amiodarone hydrochloride - Generic Drug Details

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What are the generic sources for amiodarone hydrochloride and what is the scope of freedom to operate?

Amiodarone hydrochloride is the generic ingredient in four branded drugs marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Wockhardt, Wyeth Pharms Inc, Baxter Hlthcare, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, Zydus Pharms Usa Inc, Wyeth Pharms, and Upsher Smith Labs, and is included in thirty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has fifty-one patent family members in twenty countries.

There are fifteen drug master file entries for amiodarone hydrochloride. Thirty-four suppliers are listed for this compound.

Recent Clinical Trials for amiodarone hydrochloride

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

SponsorPhase
Our Lady of the Lake Regional Medical CenterPhase 4
University of Illinois at ChicagoPhase 1
doaa rashwanPhase 2/Phase 3

See all amiodarone hydrochloride clinical trials

Recent Litigation for amiodarone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan Inc. v. Alcon Inc.2004-08-24

See all amiodarone hydrochloride litigation

Synonyms for amiodarone hydrochloride
(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
AKOS015844018
Amio-Aqueous
Amiodar
Amiodarone (hydrochloride)
Amiodarone HCL
Amiodarone hydrochloride (JP17/USAN)
Amiodarone hydrochloride [JAN]
Amiodarone hydrochloride [USP:JAN]
Amiodarone Hydrochloride 1.0 mg/ml in Methanol (as free base)
Amiodarone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Amiodaronum hydrochloride
AN-6656
Ancaron
Ancaron (TN)
Angoron
API0001454
Atlansil
BBC/822
BC207085
BCP13645
BG0032
C25H30ClI2NO3
calcium channel (L type) blocker
CAS-19774-82-4
CC-24084
CCG-39607
CHEBI:2664
CHEMBL1083993
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
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
Nexterone
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
SR-01000003087
SR-01000003087-2
SR-01000003087-8
SW196856-4
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 amiodarone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077834-001 Oct 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wockhardt AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077610-001 Oct 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Teva AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074895-001 Apr 16, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mayne Pharma Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-002 Dec 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 204550-001 Oct 25, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amiodarone hydrochloride

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.