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Serving leading biopharmaceutical companies globally:

UBS
Boehringer Ingelheim
Queensland Health
AstraZeneca
Harvard Business School
McKinsey
Deloitte
Citi
Healthtrust
Julphar

Generated: December 17, 2017

DrugPatentWatch Database Preview

Amifostine - Generic Drug Details

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What are the generic drug sources for amifostine and what is the scope of amifostine freedom to operate?

Amifostine
is the generic ingredient in two branded drugs marketed by Mylan Labs Ltd, Sun Pharma Global, and Clinigen Hlthcare, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amifostine has sixteen patent family members in twelve countries.

There are six drug master file entries for amifostine. Three suppliers are listed for this compound.

Pharmacology for amifostine

Medical Subject Heading (MeSH) Categories for amifostine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma GlobalAMIFOSTINEamifostineINJECTABLE;INJECTION077126-001Mar 14, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-001Dec 8, 1995APRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Labs LtdAMIFOSTINEamifostineINJECTABLE;INJECTION204363-001Jul 17, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Clinigen HlthcareETHYOLamifostineINJECTABLE;INJECTION020221-002Sep 10, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amifostine

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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Non-Orange Book Patents for Generic Ingredient: amifostine

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 Ingredient: amifostine

Country Document Number Estimated Expiration
Australia739068► Subscribe
Austria326956► Subscribe
Germany69834658► Subscribe
Australia1718499► Subscribe
European Patent Office1039887► Subscribe
European Patent Office1537861► Subscribe
Japan2006188532► Subscribe
Spain2260857► Subscribe
Denmark1039887► Subscribe
China1283994► 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:

Healthtrust
Boehringer Ingelheim
Citi
Cipla
US Army
Moodys
Julphar
Accenture
Cerilliant
Cantor Fitzgerald

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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