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Last Updated: March 8, 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 freedom to operate?

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-two 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
Suppliers / Packagers: 32
Bulk Api Vendors: 92
Clinical Trials: 134
Patent Applications: 971
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
University of CalgaryPhase 4
University of WashingtonPhase 4
Marrek, INCPhase 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
Taro AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 076362-001 Nov 29, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075188-001 Feb 24, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-003 Dec 28, 2017 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

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:

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Mallinckrodt

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