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Generated: May 29, 2017

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Capecitabine - Generic Drug Details

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What are the generic sources for capecitabine and what is the scope of capecitabine patent protection?

is the generic ingredient in two branded drugs marketed by Amneal Pharms, Mylan Pharms Inc, Teva Pharms Usa, Shilpa Medicare Ltd, West-ward Pharms Int, Accord Hlthcare, and Hoffmann La Roche, and is included in seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: capecitabine

Drug Master File Entries: see list28
Suppliers / Packagers: see list15
Bulk Api Vendors: see list78
Clinical Trials: see list407
Patent Applications: see list7,092
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
TABLET;ORAL020896-002Apr 30, 1998ABRXYesYes► Subscribe► Subscribe
West-ward Pharms Int
TABLET;ORAL200483-002Jul 14, 2016ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
TABLET;ORAL090943-001Aug 8, 2014ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
TABLET;ORAL204741-001Feb 28, 2017ABRXNoNo► Subscribe► Subscribe
Shilpa Medicare Ltd
TABLET;ORAL207456-002Dec 12, 2016ABRXNoNo► 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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