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Serving 500+ biopharmaceutical companies globally:

Argus Health
Citi
McKinsey
Cipla
Fuji
Chinese Patent Office
Chubb
Novartis
Boehringer Ingelheim
US Army

Generated: August 17, 2017

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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 Clinigen Hlthcare and Sun Pharma Global, and is included in two 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 fourteen patent family members in twelve countries.

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

Summary for Generic Name: amifostine

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packagers: see list3
Bulk Api Vendors: see list47
Clinical Trials: see list81
Patent Applications: see list4,712
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amifostine at DailyMed

Pharmacology for Ingredient: amifostine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-002Sep 10, 1999DISCNNoNo► Subscribe► Subscribe ► Subscribe
Sun Pharma Global
AMIFOSTINE
amifostine
INJECTABLE;INJECTION077126-001Mar 14, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-001Dec 8, 1995APRXYesYes► 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 Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-002Sep 10, 1999► Subscribe► Subscribe
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-001Dec 8, 1995► Subscribe► Subscribe
Clinigen Hlthcare
ETHYOL
amifostine
INJECTABLE;INJECTION020221-001Dec 8, 1995► 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
Australia1718499► Subscribe
Austria326956► Subscribe
Portugal1039887► Subscribe
Japan2001525359► Subscribe
Australia739068► 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 500+ biopharmaceutical companies globally:

McKesson
Moodys
Colorcon
Johnson and Johnson
US Army
Baxter
Fish and Richardson
Fuji
Federal Trade Commission
AstraZeneca

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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