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Serving leading biopharmaceutical companies globally:

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Generated: December 17, 2017

DrugPatentWatch Database Preview

FLUDARA Drug Profile

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Which patents cover Fludara, and what generic alternatives are available?

Fludara is a drug marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, and Sandoz. and is included in twelve NDAs.

The generic ingredient in FLUDARA is fludarabine phosphate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme CorpFLUDARAfludarabine phosphateINJECTABLE;INJECTION020038-001Apr 18, 1991DISCNYesNo► Subscribe► Subscribe► Subscribe
HospiraFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION077790-001Apr 6, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Custopharm IncFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION076349-001Aug 28, 2003APRXNoNo► Subscribe► Subscribe► Subscribe
SandozFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION022137-001Sep 21, 2007APRXYesYes► Subscribe► Subscribe► Subscribe
Mustafa Nevzat IlacFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION090724-001Sep 27, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Actavis LlcFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION203738-001Feb 28, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Actavis TotowaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078610-001Feb 11, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078544-001Oct 15, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION078393-001Oct 15, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Labs LtdFLUDARABINE PHOSPHATEfludarabine phosphateINJECTABLE;INJECTION200648-001Oct 16, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Cantor Fitzgerald
US Army
Federal Trade Commission

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