Last Updated: June 22, 2026

AMIODARONE Drug Patent Profile

Name: AMIODARONE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Amiodarone patents expire, and what generic alternatives are available?

Amiodarone 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, Zhejiang Poly Pharm, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Pharmobedient, Rubicon Research, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc. and is included in thirty-one NDAs.

The generic ingredient in AMIODARONE 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

A generic version of AMIODARONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30^th, 1998.

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Summary for AMIODARONE

US Patents:	0
Applicants:	26
NDAs:	31
Drug Prices:	Drug price information for AMIODARONE
Drug Sales Revenues:	Drug sales revenues for AMIODARONE
DailyMed Link:	AMIODARONE at DailyMed

Drug patent expirations by year for AMIODARONE

US Patents and Regulatory Information for AMIODARONE

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Glossary

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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	079029-001	Sep 16, 2008	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Taro	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075424-001	Mar 30, 2001	AB	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rubicon Research	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-002	Feb 26, 2021	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Taro	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	076362-002	Dec 2, 2003		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rubicon Research	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-001	Nov 6, 2008	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start 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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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.