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Last Updated: April 26, 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.

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:	32
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	158
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
Kun Hua	Phase 4
Rush University Medical Center	N/A
Massachusetts General Hospital	Phase 4

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
Upsher Smith Labs	PACERONE	amiodarone hydrochloride	TABLET;ORAL	075135-003	Jul 2, 2020	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
Unichem	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	213446-001	Jul 21, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-001	Dec 23, 1998		DISCN	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
>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	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	⤷ 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	022325-001	Dec 24, 2008	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	6444548		⤷ Try a Trial
Australia	2009241858	Sulfoalkyl ether cyclodextrin compositions	⤷ Try a Trial
Eurasian Patent Organization	031355	КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF)	⤷ Try a Trial
Japan	2010539193		⤷ Try a Trial
European Patent Office	2268269	COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)	⤷ Try a Trial
Japan	4923144		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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