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: October 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210308

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NDA 210308 describes YONSA, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YONSA profile page.

The generic ingredient in YONSA 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 210308
Tradename:YONSA
Applicant:Sun Pharma Global
Ingredient:abiraterone acetate
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YONSA abiraterone acetate TABLET;ORAL 210308 NDA Sun Pharmaceutical Industries, Inc. 47335-401 47335-401-81 120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)
Paragraph IV (Patent) Challenges for 210308
Tradename Dosage Ingredient NDA Submissiondate
YONSA TABLET;ORAL abiraterone acetate 210308 2018-07-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:May 22, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 20, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER
Patent:  Start TrialPatent Expiration:Mar 17, 2034Product Flag?YSubstance Flag?Delist Request?

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