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Serving leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Farmers Insurance
Covington
Medtronic
QuintilesIMS
Merck
Novartis
US Department of Justice
Chubb

Generated: December 11, 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 Genzyme Corp, Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, and Sanofi Aventis Us, 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-nine patent family members in thirty-four countries.

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

Pharmacology for fludarabine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Genzyme CorpFLUDARAfludarabine phosphateINJECTABLE;INJECTION020038-001Apr 18, 1991DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION200648-001Oct 16, 2012APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsOFORTAfludarabine phosphateTABLET;ORAL022273-001Dec 18, 2008DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
HospiraFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION077790-001Apr 6, 2007APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
SandozFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION022137-001Sep 21, 2007APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078393-001Oct 15, 2007APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsOFORTAfludarabine phosphateTABLET;ORAL022273-001Dec 18, 2008DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sagent PharmsFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION076661-001Apr 28, 2004APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis TotowaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078610-001Feb 11, 2009APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078544-001Oct 15, 2007APRXNoNo► Subscribe► 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 CorpFLUDARAfludarabine phosphateINJECTABLE;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
Canada2313486► Subscribe
China1306929► Subscribe
South Africa9811338► Subscribe
Slovenia1047704► Subscribe
Japan2005519043► Subscribe
Taiwan424093► Subscribe
EcuadorSP045185► Subscribe
TaiwanI255187► Subscribe
Spain2190136► Subscribe
Germany10164510► 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:

Federal Trade Commission
Argus Health
Fuji
US Army
Julphar
Harvard Business School
Johnson and Johnson
Farmers Insurance
US Department of Justice
Citi

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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