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Amiodarone hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amiodarone hydrochloride?

Amiodarone hydrochloride is the generic ingredient in four branded drugs marketed by Hospira, Wockhardt, Sandoz, Mylan Institutional, Bedford, Taro, Baxter Hlthcare, Zydus Pharms Usa Inc, Akorn, Hikma Farmaceutica, Upsher Smith, Teva Pharms, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Teva Pharms Usa, Murty Pharms, Wyeth Pharms Inc, Apotex Inc, Hospira Inc, Ben Venue, Mylan, Mayne Pharma Inc, Intl Medication Sys, Par Sterile Products, Teva, and Bedford Labs, and is included in thirty-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has thirty-eight patent family members in nineteen countries.

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

Summary for Generic Name: amiodarone hydrochloride

Tradenames:4
Patents:3
Applicants:27
NDAs:32
Drug Master File Entries: see list15
Suppliers / Packagers: see list36
Bulk Api Vendors: see list49
Clinical Trials: see list1,020
Patent Applications: see list794
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amiodarone hydrochloride at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
INJECTABLE;INJECTION075761-001Oct 15, 2002RXNoYes► Subscribe► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-003Nov 16, 2010RXYesYes6,869,939► SubscribeY ► Subscribe
Mylan
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET;ORAL075188-001Feb 24, 1999RXNoNo► Subscribe► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-002Nov 16, 2010RXYesYes6,869,939► SubscribeY ► Subscribe
Apotex Inc
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET;ORAL078578-001Nov 6, 2008RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amiodarone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 20085,134,127► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 20085,376,645► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,410,077Sulfoalkyl ether cyclodextrin compositions► Subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: amiodarone hydrochloride

Country Document Number Estimated Expiration
South Korea20040106452► Subscribe
Japan2015110671► Subscribe
China105288650► Subscribe
South Korea101314803► Subscribe
European Patent Office2402008► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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