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Last Updated: May 2, 2024

Amiodarone hydrochloride - Generic Drug Details

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What are the generic 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-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

Anatomical Therapeutic Chemical (ATC) Classes for amiodarone hydrochloride

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Taro	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075424-002	Dec 18, 2002	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bedford	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076018-001	Oct 15, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	074739-001	Nov 30, 1998	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
>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
World Intellectual Property Organization (WIPO)	2009134347		⤷ Try a Trial
Brazil	PI0905080	Composições, processo para reparar uma composição e produto	⤷ Try a Trial
Japan	2012072160	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION	⤷ Try a Trial
Japan	4923144		⤷ Try a Trial
>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.