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Last Updated: February 23, 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-one 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
Rubicon AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 078578-002 Feb 26, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ben Venue AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076088-001 Oct 15, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 079029-003 Jan 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-003 Dec 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 079029-002 Jan 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074739-001 Nov 30, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs PACERONE amiodarone hydrochloride TABLET;ORAL 075135-001 Apr 30, 1998 AB 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 022325-002 Nov 16, 2010 ⤷  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 022325-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amiodarone hydrochloride

Country Patent Number Title Estimated Expiration
Mexico 2010004900 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) ⤷  Try a Trial
South Korea 101314803 ⤷  Try a Trial
Japan 2012072160 SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION ⤷  Try a Trial
European Patent Office 3363430 COMPOSITIONS D'ÉTHER SULFOALKYLE DE CYCLODEXTRINE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try a Trial
Israel 243654 תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions) ⤷  Try a Trial
Japan 2017019879 スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try a Trial
Hong Kong 1219883 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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