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-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

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
Acella	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	077834-001	Oct 30, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-003	Feb 26, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-001	Nov 6, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	PACERONE	amiodarone hydrochloride	TABLET;ORAL	075135-003	Jul 2, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Farmaceutica	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	077234-001	Feb 25, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Par Sterile Products	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076394-001	Apr 25, 2003		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	022325-003	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
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	⤷ 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
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)	⤷ Sign Up
China	114053423	磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)	⤷ Sign Up
Israel	208956	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)	⤷ Sign Up
Israel	243654	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)	⤷ Sign Up
Japan	4923144		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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