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Last Updated: May 19, 2024

AMIODARONE HYDROCHLORIDE Drug Patent Profile


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

Amiodarone Hydrochloride is a drug 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, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Mylan, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc. and is included in thirty 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.

DrugPatentWatch® 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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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
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
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-002 Dec 2, 2003 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 078578-001 Nov 6, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-001 Nov 29, 2002 AB 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
Acella AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077610-001 Oct 30, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076394-001 Apr 25, 2003 DISCN 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

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