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Last Updated: June 2, 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 patent protection?

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.

Summary for AMIODARONE HYDROCHLORIDE

International Patents:	29
US Patents:	1
Tradenames:	4
Applicants:	28
NDAs:	34
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	159
Patent Applications:	1,086
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMIODARONE HYDROCHLORIDE
What excipients (inactive ingredients) are in AMIODARONE HYDROCHLORIDE?	AMIODARONE HYDROCHLORIDE excipients list
DailyMed Link:	AMIODARONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AMIODARONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
Kun Hua	Phase 4
Rush University Medical Center	N/A

See all AMIODARONE HYDROCHLORIDE clinical trials

Pharmacology for AMIODARONE HYDROCHLORIDE

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 3A Inhibitors

Medical Subject Heading (MeSH) Categories for AMIODARONE HYDROCHLORIDE

Anti-Arrhythmia Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Potassium Channel Blockers
Sodium Channel Blockers
Vasodilator Agents

US Patents and Regulatory Information for AMIODARONE HYDROCHLORIDE

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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
Mylan	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075188-001	Feb 24, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075424-001	Mar 30, 2001	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-001	Dec 23, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AMIODARONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20110010742	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS	⤷ Sign Up
China	114053423	磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)	⤷ Sign Up
Eurasian Patent Organization	031355	КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF)	⤷ Sign Up
>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.