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Last Updated: August 15, 2020

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AMIODARONE HYDROCHLORIDE Drug Profile

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Which patents cover Amiodarone Hydrochloride, and what generic alternatives are available?

Amiodarone Hydrochloride is a drug 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, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, and Zydus Pharms Usa Inc. and is included in twenty-nine NDAs.

The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Amiodarone Hydrochloride

A generic version of AMIODARONE HYDROCHLORIDE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.

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Drug patent expirations by year for AMIODARONE HYDROCHLORIDE
Recent Clinical Trials for AMIODARONE HYDROCHLORIDE

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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
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-002 Dec 2, 2003 RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075315-001 Dec 23, 1998 AB RX No Yes   Start Trial   Start Trial   Start Trial
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-001 Nov 29, 2002 AB 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Express Scripts
Harvard Business School
Moodys
Merck

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