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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, Shilpa Medicare Ltd, West-ward Pharms Int, Accord Hlthcare, and Hoffmann La Roche, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for capecitabine. Fourteen suppliers are listed for this compound.

Summary for Generic Name: capecitabine

Tradenames:2
Patents:0
Applicants:6
NDAs:6
Drug Master File Entries: see list28
Suppliers / Packagers: see list14
Bulk Api Vendors: see list78
Clinical Trials: see list406
Patent Applications: see list13,526
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:capecitabine at DailyMed

Pharmacology for Ingredient: capecitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
CAPECITABINE
capecitabine
TABLET;ORAL202593-002Apr 23, 2015RXNoNo► subscribe► subscribe
Shilpa Medicare Ltd
CAPECITABINE
capecitabine
TABLET;ORAL207456-002Dec 12, 2016RXNoNo► subscribe► subscribe
Accord Hlthcare
CAPECITABINE
capecitabine
TABLET;ORAL202593-001Apr 23, 2015RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: capecitabine

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