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Profile for Tradename: ZYTIGA

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Zytiga is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in twenty-five countries.

The generic ingredient in ZYTIGA is abiraterone acetate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abiraterone acetate profile page.

Summary for Tradename: ZYTIGA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
2013 Sales:$775,269,000

Clinical Trials for: ZYTIGA

A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
Status: Recruiting Condition: Prostatic Neoplasms

A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
Status: Completed Condition: Healthy

A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
Status: Completed Condition: Healthy

A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet
Status: Completed Condition: Healthy Participants

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
Status: Active, not recruiting Condition: Prostate Neoplasms

A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
Status: Recruiting Condition: Metastatic Castration-Resistant Prostate Cancer

A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Status: Recruiting Condition: Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer (mCRPC)

RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistant (The RESTORE Study)
Status: Recruiting Condition: Prostate Cancer

Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
Status: Completed Condition: Healthy

A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
Status: Completed Condition: Prostate Cancer

Courtesy of ClinicalTrials.org
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
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes5,604,213<disabled>YY<disabled>
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes8,822,438<disabled><disabled>
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes<disabled><disabled>
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes<disabled><disabled>
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Paragraph IV activity for: ZYTIGA

Drugname Dosage Strength RLD Submissiondate
abiraterone acetateTablets250 mgZytiga4/28/2015

International Patent Family for Tradename: ZYTIGA

Country Document Number Publication Date
Serbia52956Feb 28, 2014
Norway20091190Mar 20, 2009
United Kingdom2282377Apr 05, 1995
Japan2742331Apr 22, 1998
Germany122012000012Jun 14, 2012
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ISSN: 2162-2639

Preferred citation:

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

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