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Generated: May 25, 2017

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Cladribine - Generic Drug Details

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

is the generic ingredient in two branded drugs marketed by West-ward Pharms Int, Mylan Labs Ltd, Janssen Pharms, and Fresenius Kabi Usa, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for cladribine. Three suppliers are listed for this compound.

Summary for Generic Name: cladribine

Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Bulk Api Vendors: see list70
Clinical Trials: see list35
Patent Applications: see list7,137
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cladribine at DailyMed

Pharmacology for Ingredient: cladribine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INJECTABLE;INJECTION020229-001Feb 26, 1993DISCNYesNo► Subscribe► Subscribe
West-ward Pharms Int
INJECTABLE;INJECTION075405-001Feb 28, 2000APRXNoNo► Subscribe► Subscribe
Fresenius Kabi Usa
INJECTABLE;INJECTION076571-001Apr 22, 2004APRXNoYes► Subscribe► Subscribe
Mylan Labs Ltd
INJECTABLE;INJECTION200510-001Oct 6, 2011APRXNoNo► Subscribe► Subscribe
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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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