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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

AMIODARONE HYDROCHLORIDE Drug Profile


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Which patents cover Amiodarone Hydrochloride, and what generic alternatives are available?

Amiodarone Hydrochloride is a drug 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, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, and Zydus Pharms Usa Inc. and is included in twenty-nine NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Amiodarone Hydrochloride

A generic version of AMIODARONE HYDROCHLORIDE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.

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Drug patent expirations by year for AMIODARONE HYDROCHLORIDE
Recent Clinical Trials for AMIODARONE HYDROCHLORIDE

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

SponsorPhase
Jeffrey MoakPhase 4
Vanderbilt University Medical CenterPhase 3
University Hospital, CaenPhase 4

See all AMIODARONE HYDROCHLORIDE clinical trials

Recent Litigation for AMIODARONE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.2019-07-12
CELGENE CORPORATION v. SYNTHON PHARMECEUTICALS, INC.2018-06-19
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED2018-03-29

See all AMIODARONE HYDROCHLORIDE litigation

Synonyms for AMIODARONE 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-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-diiodophenyl ketone hydrochloride
2-Butyl-3-benzofuryl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone hydrochloride
51087 N HCl
774A824
976728SY6Z
A 8423
AB0012080
AC-078
ACT02681
AK149490
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
amiodarone-hcl
Amiodaronum hydrochloride
Ancaron
Ancaron (TN)
Angoron
API0001454
Atlansil
BBC/822
BCP13645
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
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,(2-butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]-,hydrochloride
Methanone,5-diiodophenyl]-, hydrochloride
MFCD00069204
Miodrone
MLS000028520
MLS001076313
MLS001424272
MLS002222247
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
Q27271976
Renodoron
Ritmocardyl
Rythmarone
s1979
SAM001246646
SCHEMBL41348
SK&F-33134-A
SKF 33134 A
SKF 33134-A
SKF-33134-A
SKF-33134A
SMR000058296
SPECTRUM2300165
SR-01000003087
SR-01000003087-2
SR-01000003087-8
SW196856-4
Tox21_113478
Tox21_300395
Tox21_500122
Trangorex
UNII-976728SY6Z
Uro-Septra
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
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-002 Dec 2, 2003 RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075315-001 Dec 23, 1998 AB RX No Yes   Start Trial   Start Trial   Start Trial
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-001 Nov 29, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075315-002 Jun 30, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Akorn AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076232-001 Jul 5, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Wockhardt AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077834-001 Oct 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Murty Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069-001 Apr 8, 2005 AB 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Express Scripts
Harvard Business School
Moodys
Merck

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