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Serving leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
Farmers Insurance
Queensland Health
Dow
Johnson and Johnson
Citi
QuintilesIMS
Baxter
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Generated: December 12, 2017

DrugPatentWatch Database Preview

ETHYOL Drug Profile

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Which patents cover Ethyol, and when can generic versions of Ethyol launch?

Ethyol is a drug marketed by Clinigen Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in twelve countries.

The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amifostine profile page.
Drug patent expirations by year for ETHYOL

Pharmacology for ETHYOL

Medical Subject Heading (MeSH) Categories for ETHYOL

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-001Dec 8, 1995APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ETHYOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-001Dec 8, 1995► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-001Dec 8, 1995► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-001Dec 8, 1995► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ETHYOL

Drugname Dosage Strength RLD Submissiondate
amifostineFor Injection500 mg/vialEthyol4/16/2004

Non-Orange Book Patents for Tradename: ETHYOL

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
6,586,476 Methods for the treatment of nephro-disorders using aminothiol compounds► Subscribe
7,105,575Methods for the treatment of neuro- disorders using aminothiol compounds► 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: ETHYOL

Country Document Number Estimated Expiration
Japan2006188532► Subscribe
Japan2001525359► Subscribe
China1161113► Subscribe
Portugal1039887► Subscribe
Austria326956► Subscribe
China1283994► Subscribe
Brazil9813524► Subscribe
Spain2260857► Subscribe
Australia739068► Subscribe
Australia1718499► 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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Serving leading biopharmaceutical companies globally:

US Department of Justice
Novartis
Medtronic
Cipla
Mallinckrodt
Federal Trade Commission
Colorcon
Teva
Merck
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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