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, Zhejiang Poly Pharm, Wyeth Pharms Inc, Baxter Hlthcare, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Norvium Bioscience, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, Zydus Pharms Usa Inc, and Wyeth Pharms, and is included in thirty-five 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-three suppliers are listed for this compound.

Summary for AMIODARONE HYDROCHLORIDE

International Patents:	29
US Patents:	1
Tradenames:	4
Applicants:	29
NDAs:	35
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	161
Patent Applications:	1,086
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

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
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-001	Nov 6, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076108-001	Oct 15, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva Pharms	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	074739-001	Nov 30, 1998	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	075955-001	Oct 18, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	203885-001	Nov 25, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	PACERONE	amiodarone hydrochloride	TABLET;ORAL	075135-002	Apr 12, 2005	AB	RX	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	022325-002	Nov 16, 2010	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010	⤷ 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	022325-001	Dec 24, 2008	⤷ 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
New Zealand	589290	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS	⤷ Sign Up
Eurasian Patent Organization	201000828	СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА	⤷ Sign Up
Japan	2017019879	スルホアルキルエーテルシクロデキストリン組成物 (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
European Patent Office	3363430	COMPOSITIONS D'ÉTHER SULFOALKYLE DE CYCLODEXTRINE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)	⤷ Sign Up
Australia	2009241858	Sulfoalkyl ether cyclodextrin compositions	⤷ Sign Up
China	114053423	磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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