Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202379

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NDA 202379 describes ZYTIGA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the ZYTIGA profile page.

The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 202379
Tradename:ZYTIGA
Applicant:Janssen Biotech
Ingredient:abiraterone acetate
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYTIGA abiraterone acetate TABLET;ORAL 202379 NDA Janssen Biotech, Inc. 57894-150 57894-150-12 120 TABLET in 1 BOTTLE (57894-150-12)
ZYTIGA abiraterone acetate TABLET;ORAL 202379 NDA AUTHORIZED GENERIC Janssen Biotech, Inc. 57894-155 57894-155-12 120 TABLET in 1 BOTTLE (57894-155-12)
Paragraph IV (Patent) Challenges for 202379
Tradename Dosage Ingredient NDA Submissiondate
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2017-08-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2015-04-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 28, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 7, 2021
Regulatory Exclusivity Use:ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 14, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 7, 2021
Regulatory Exclusivity Use:ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER
Patent:  Start TrialPatent Expiration:Aug 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patented Use:USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

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Serving leading biopharmaceutical companies globally:

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McKesson

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