Orange Book product · Brand (NDA)

YONSA

ABIRATERONE ACETATE

Brand (NDA)NDA 210308RX SUN PHARM

May 22, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 22, 2018
8 yr 2 mo ago
Today
Patent 9889144 expires
Listed drug product patent expiration.
Mar 17, 2034
in 7 yr 10 mo
Patent 10292990 expires
Listed method-of-use patent (U-2535) expiration.
May 20, 2034
in 8 yr

Active ingredient

ABIRATERONE ACETATE

Strength

125MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210308

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9889144	Mar 17, 2034	in 7 yr 10 mo	Product
10292990	May 20, 2034	in 8 yr	U-2535