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Last Updated: June 22, 2021

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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 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, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, Zydus Pharms Usa Inc, and Wyeth Pharms, and is included in thirty-four 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-three suppliers are listed for this compound.

Summary for AMIODARONE HYDROCHLORIDE
International Patents:51
US Patents:2
Tradenames:4
Applicants:28
NDAs:34
Drug Master File Entries: 15
Finished Product Suppliers / Packagers: 33
Raw Ingredient (Bulk) Api Vendors: 96
Clinical Trials: 135
Patent Applications: 1,007
Formulation / Manufacturing:see details
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

SponsorPhase
Won Young KimPhase 3
University of CalgaryPhase 4
PreventicePhase 4

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
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Hospira AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075955-001 Oct 18, 2002 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Teva AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074895-001 Apr 16, 1999 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Par Sterile Products AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076394-001 Apr 25, 2003 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075424-002 Dec 18, 2002 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.