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Serving leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Citi
US Army
Johnson and Johnson
Julphar
US Department of Justice
Argus Health
Farmers Insurance
Medtronic

Generated: February 22, 2018

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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 amiodarone hydrochloride freedom to operate?

Amiodarone hydrochloride
is the generic ingredient in four branded drugs marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Teva Pharms Usa, Wockhardt, Wyeth Pharms Inc, Baxter Hlthcare, Apotex Inc, Mayne Pharma Inc, Murty Pharms, Mylan, Sandoz, Taro Pharm, Teva, Teva Pharms, Zydus Pharms Usa Inc, 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 forty-four patent family members in twenty countries.

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

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
Murty Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069-001 Apr 8, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074739-001 Nov 30, 1998 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bedford Labs AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076299-001 Oct 24, 2002 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075315-001 Dec 23, 1998 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 078578-001 Nov 6, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Akorn AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076232-001 Jul 5, 2006 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-001 Jan 25, 2001 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Sterile Products AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076394-001 Apr 25, 2003 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 074895-001 Apr 16, 1999 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free 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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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 a Free Trial ➤ Try a Free Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for amiodarone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,410,077 Sulfoalkyl ether cyclodextrin compositions ➤ Try a Free Trial
9,200,088 Sulfoalkyl ether cyclodextrin compositions ➤ Try a Free Trial
9,750,822 Sulfoalkyl ether cyclodextrin compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for amiodarone hydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Fish and Richardson
Mallinckrodt
Medtronic
Cantor Fitzgerald
Citi
Queensland Health
Accenture

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 verifification 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.

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