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Capecitabine - Generic Drug Details

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Capecitabine is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Teva Pharms Usa, Roxane, Accord Hlthcare, and Hoffmann La Roche, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for capecitabine. Twelve suppliers are listed for this compound.

Summary for Generic Name: capecitabine

Tradenames:2
Patents:0
Applicants:5
NDAs:5
Drug Master File Entries: see list27
Suppliers / Packaging: see list12
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: capecitabine

Clinical Trials for: capecitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYesJun 10, 2017
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYesDec 10, 2016
Mylan Pharms Inc
CAPECITABINE
capecitabine
TABLET;ORAL090943-002Aug 8, 2014RXNo
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Expired Orange Book Patents for Generic Ingredient: capecitabine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 19984,966,891<disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 19985,472,949*PED<disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 19984,966,891<disabled>
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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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