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Last Updated: June 23, 2021

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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, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc. and is included in thirty NDAs.

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

DrugPatentWatch® 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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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   Get Started Free   Get Started Free   Get Started Free
Rubicon AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 078578-001 Nov 6, 2008 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-001 Nov 29, 2002 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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:

Boehringer Ingelheim
Express Scripts
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