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Last Updated: December 5, 2022

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, Akorn, Bedford, Bedford Labs, Ben Venue, Dr Reddys, 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, Mayne Pharma Inc, Murty Pharms, 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 are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has fifty-two patent family members in twenty 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
Massachusetts General HospitalPhase 4
Hippocration General HospitalPhase 3
Win MedicaPhase 3

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 078578-001 Nov 6, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074739-001 Nov 30, 1998 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wyeth Pharms CORDARONE amiodarone hydrochloride TABLET;ORAL 018972-001 Dec 24, 1985 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland Pharma Ltd AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077161-001 Apr 20, 2005 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 See Plans and Pricing See Plans and Pricing
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amiodarone hydrochloride

Country Patent Number Title Estimated Expiration
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) See Plans and Pricing
Eurasian Patent Organization 031355 КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF) See Plans and Pricing
Hong Kong 1219883 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
South Korea 100984197 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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 verification 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.