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Profile for Tradename: XELODA

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Xeloda is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from three suppliers.

The generic ingredient in XELODA is capecitabine. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

Summary for Tradename: XELODA

Suppliers / Packagers: see list12
2013 Sales:$754,133,000

Pharmacology for Tradename: XELODA

Clinical Trials for: XELODA

LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Status: Completed Condition: Breast Cancer

A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors
Status: Completed Condition: Solid Tumor

Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer
Status: Active, not recruiting Condition: Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; HER2/Neu-positive Breast Cancer

Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers
Status: Completed Condition: Metastatic Breast Cancer

A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
Status: Completed Condition: Advanced Solid Tumors

Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer
Status: Active, not recruiting Condition: Breast Cancer

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
Status: Recruiting Condition: Breast Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Breast Diseases; Skin Diseases

Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer
Status: Completed Condition: Breast Cancer

A Bioequivalence Study of Capecitabine Tablets
Status: Completed Condition: Metastatic Breast Cancer or Metastatic Colorectal Cancer

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Status: Completed Condition: Pancreatic Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
TABLET;ORAL020896-001Apr 30, 1998RXNo<disabled><disabled>
Hoffmann La Roche
TABLET;ORAL020896-002Apr 30, 1998RXYes<disabled><disabled>
Hoffmann La Roche
TABLET;ORAL020896-001Apr 30, 1998RXNo<disabled><disabled>
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Paragraph IV activity for: XELODA

Drugname Dosage Strength RLD Submissiondate
capecitabineTablets150 mg and 500 mgXeloda11/10/2008
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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