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Last Updated: March 28, 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
Mylan AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075188-001 Feb 24, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069-002 Apr 8, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-001 Jan 25, 2001 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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