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NEXTERONE Drug Profile

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Which patents cover Nexterone, and what substitute generic drugs are available?

Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-eight patent family members in nineteen countries.

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

Summary for Tradename: NEXTERONE

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list49
Clinical Trials: see list2
Patent Applications: see list533
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NEXTERONE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 2008RXYesNo7,635,773► SubscribeY ► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-002Nov 16, 2010RXYesYes6,869,939► SubscribeY ► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 2008RXYesNo6,869,939► SubscribeY ► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-002Nov 16, 2010RXYesYes7,635,773► SubscribeY ► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-003Nov 16, 2010RXYesYes7,635,773► SubscribeY ► Subscribe
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Expired Patents for Tradename: NEXTERONE

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 Tradename: NEXTERONE

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 Tradename: NEXTERONE

Country Document Number Estimated Expiration
South Korea20040106452► Subscribe
Israel208956► Subscribe
Japan5656692► Subscribe
Australia2009241858► Subscribe
Japan2015110671► 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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