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Last Updated: August 15, 2020

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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 Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Wockhardt, Wyeth Pharms Inc, Baxter Hlthcare, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, Zydus Pharms Usa Inc, Wyeth Pharms, and Upsher Smith Labs, and is included in thirty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has fifty-one patent family members in twenty countries.

There are fifteen drug master file entries for amiodarone hydrochloride. Thirty suppliers are listed for this compound.

Summary for amiodarone hydrochloride
Recent Clinical Trials for amiodarone hydrochloride

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

SponsorPhase
Ottawa Hospital Research InstituteEarly Phase 1
Nicolaus Copernicus UniversityPhase 2/Phase 3
Maimonides Medical CenterPhase 2

See all amiodarone hydrochloride clinical trials

US Patents and Regulatory Information for amiodarone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075315-002 Jun 30, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Murty Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069-002 Apr 8, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Wyeth Pharms CORDARONE amiodarone hydrochloride TABLET;ORAL 018972-001 Dec 24, 1985 DISCN Yes No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wockhardt AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077834-001 Oct 30, 2008 AP RX No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008   Start Trial   Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Colorcon
Baxter
Harvard Business School
Johnson and Johnson

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