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Generated: October 21, 2017

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Fludarabine phosphate - Generic Drug Details

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What are the generic drug sources for fludarabine phosphate and what is the scope of fludarabine phosphate patent protection?

Fludarabine phosphate
is the generic ingredient in three branded drugs marketed by Actavis Totowa, Mustafa Nevzat Ilac, Sandoz, Genzyme Corp, Actavis Llc, Fresenius Kabi Usa, Mylan Labs Ltd, Sagent Pharms, Sanofi Aventis Us, and Hospira, and is included in thirteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fludarabine phosphate has sixty-seven patent family members in thirty-four countries.

There are ten drug master file entries for fludarabine phosphate. Nine suppliers are listed for this compound.

Summary for Generic Name: fludarabine phosphate

US Patents:2
Tradenames:3
Applicants:10
NDAs:13
Drug Master File Entries: see list10
Suppliers / Packagers: see list9
Bulk Api Vendors: see list48
Clinical Trials: see list1,571
Patent Applications: see list6,751
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fludarabine phosphate at DailyMed

Pharmacology for Ingredient: fludarabine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION022137-001Sep 21, 2007APRXYesYes► Subscribe► Subscribe► Subscribe
Mustafa Nevzat Ilac
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION090724-001Sep 27, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION078544-001Oct 15, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION200647-001Dec 21, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Totowa
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION078610-001Feb 11, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Sagent Pharms
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION076349-001Aug 28, 2003APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION078393-001Oct 15, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION200648-001Oct 16, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION077790-001Apr 6, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Sagent Pharms
FLUDARABINE PHOSPHATE
fludarabine phosphate
INJECTABLE;INJECTION076661-001Apr 28, 2004APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fludarabine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp
FLUDARA
fludarabine phosphate
INJECTABLE;INJECTION020038-001Apr 18, 1991► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fludarabine phosphate

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
6,046,322 Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5%► 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: fludarabine phosphate

Country Document Number Estimated Expiration
Serbia50398► Subscribe
Poland341659► Subscribe
South Africa9811338► Subscribe
Russian Federation2004122479► Subscribe
Australia2155099► Subscribe
Germany10164510► Subscribe
CroatiaP20040648► Subscribe
World Intellectual Property Organization (WIPO)03053418► Subscribe
Czech Republic20002159► Subscribe
Ukraine78741► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Cipla
Medtronic
Accenture
Covington
US Department of Justice
Novartis
Julphar
Chubb

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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