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ABIRATERONE ACETATE

ANDA

ABIRATERONE ACETATE | A208446 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZYTIGA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BTG INTERNATIONAL LIMITED et al v. AMNEAL PHARMACEUTICALS LLC,. et al 2:2015cv05909 2 patentsANDA 208274, 208327, 208453, 208371, 208416, 208446, 208168, 208440, 208432, 208339, 208380, 208349abiraterone acetate	D.N.J.	2015-07-31	Terminated 2022-02-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain27 active DMFs3 inactive

24 active API suppliers hold Drug Master Files for this ingredient.

STERLING SPAABIRATERONE ACETATE

DMF 267252012

CHEMWERTH INCABIRATERONE ACETATE

DMF 268942014

OLON SPAABIRATERONE ACETATE

DMF 273762013

MSN LABORATORIES PRIVATE LTDABIRATERONE ACETATE USP [ROUTE CODE - "AY"]

DMF 278292013

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDABIRATERONE ACETATE

DMF 278532013

STERLING CHEMICAL MALTA LTDABIRATERONE ACETATE

DMF 279892014

DR REDDYS LABORATORIES LTDABIRATERONE ACETATE

DMF 280382014

ALP PHARM BEIJING CO LTDABIRATERONE ACETATE

DMF 282922014

HETERO LABS LTDABIRATERONE ACETATE

DMF 283832014

ZACH SYSTEM SAABIRATERONE ACETATE

DMF 284122014

INDUSTRIALE CHIMICA SRLABIRATERONE ACETATE USP

DMF 287012014

TAPI NL BVABIRATERONE ACETATE

DMF 287642014

RAKS PHARMA PVT LTDABIRATERONE ACETATE USP

DMF 289052014

SUN PHARMACEUTICAL INDUSTRIES LTDABIRATERONE ACETATE

DMF 289592015

AURISCO PHARMACEUTICAL CO LTDABIRATERONE ACETATE

DMF 313092017

TIANJIN WEIJIE PHARMACEUTICAL CO LTDABIRATERONE ACETATE

DMF 315822017

SHANDONG ANHONG PHARMACEUTICAL CO LTDABIRATERONE ACETATE (NON-STERILE)

DMF 326372018

MSN LABORATORIES PRIVATE LTDABIRATERONE

DMF 326582018

INDUSTRIALE CHIMICA SRLABIRATERONE ACETATE USP (NP)

DMF 343202019

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDABIRATERONE ACETATE API

DMF 362842021

SHANDONG SIRUI PHARMACEUTICAL CO LTDABIRATERONE ACETATE

DMF 363142021

CDYMAX (INDIA) PHARMA PRIVATE LTDABIRATERONE ACETATE

DMF 366702022

APITORIA PHARMA PRIVATE LTDABIRATERONE ACETATE USP

DMF 375292022

CIPLA LTDABIRATERONE ACETATE USP

DMF 376682023

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDABIRATERONE ACETATE

DMF 379652023

MSN LABORATORIES PRIVATE LTDABIRATERONE ACETATE USP

DMF 396972024

SHILPA PHARMA LIFESCIENCES LTDABIRATERONE ACETATE USP

DMF 419012025

CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDInactiveABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 267792012

CIPLA LTDInactiveABIRATERONE ACETATE

DMF 291252015

SCINOPHARM TAIWAN LTDInactiveABIRATERONE ACETATE USP

DMF 305872016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 1, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 31, 2018

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 14, 2020