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Last Updated: March 29, 2024

Amiodarone hydrochloride - Generic Drug Details


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What are the generic drug 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 Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Wyeth Pharms Inc, Baxter Hlthcare, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Mylan, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, Zydus Pharms Usa Inc, and Wyeth Pharms, and is included in thirty-four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has twenty-nine patent family members in thirteen countries.

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

Recent Clinical Trials for amiodarone hydrochloride

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

SponsorPhase
Kun HuaPhase 4
Rush University Medical CenterN/A
Massachusetts General HospitalPhase 4

See all amiodarone hydrochloride clinical trials

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
Hospira AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 203884-001 Nov 25, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 078578-003 Feb 26, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms Inc CORDARONE amiodarone hydrochloride INJECTABLE;INJECTION 020377-001 Aug 3, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-002 Dec 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Farmaceutica AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077234-001 Feb 25, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amiodarone hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2268269 COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try a Trial
New Zealand 589290 SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS ⤷  Try a Trial
Israel 243654 תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions) ⤷  Try a Trial
Japan 6276828 ⤷  Try a Trial
China 114053423 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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