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Last Updated: November 13, 2019

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ABIRATERONE ACETATE - Generic Drug Details

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What are the generic sources for abiraterone acetate and what is the scope of patent protection?

Abiraterone acetate is the generic ingredient in three branded drugs marketed by Amneal Pharms, Apotex Inc, Hikma Pharms, Msn Labs Pvt Ltd, Mylan, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharma Global, and Janssen Biotech, and is included in ten NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has seventy-one patent family members in thirty-one countries.

There are twenty-five drug master file entries for abiraterone acetate. Fourteen suppliers are listed for this compound.

Drug Prices for ABIRATERONE ACETATE

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Recent Clinical Trials for ABIRATERONE ACETATE

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SponsorPhase
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3
PPDPhase 2/Phase 3
NRG OncologyPhase 3

See all ABIRATERONE ACETATE clinical trials

Recent Litigation for ABIRATERONE ACETATE

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District Court Litigation
Case NameDate
BTG INTERNATIONAL LIMITED v. QILU PHARMACEUTICAL CO., LTD.2018-11-28
Sun Pharma Global FZE v. Teva Pharmaceuticals Industries Limited2018-10-09
BTG INTERNATIONAL LIMITED v. MSN PHARMACEUTICALS INC.2018-02-20

See all ABIRATERONE ACETATE litigation

PTAB Litigation
PetitionerDate
ACTAVIS LABORATORIES FL, INC.2017-02-08
Wockhardt Bio AG2016-08-10
Mylan Pharmaceuticals Inc.2016-06-30

See all ABIRATERONE ACETATE litigation

Medical Subject Heading (MeSH) Categories for ABIRATERONE ACETATE
Synonyms for ABIRATERONE ACETATE
(1S,2R,5S,10R,11S,15S)-2,15-dimethyl-14-(pyridin-3-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-7,13-dien-5-yl acetate
(3?)-17-(3-Pyridinyl)androsta-5,16-dien-3-yl acetate
(3beta)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol acetate (ester)
(3beta)-17-(pyridin-3-yl)androsta-5,16-dien-3-yl acetate
(3S,8R,9S,10R,13S,14S)-10,13-DIMETHYL-17-(PYRIDIN-3-YL)-2,3,4,7,8,9,10,11,12,13,14,15-DODECAHYDRO-1H-CYCLOPENTA[A]PHENANTHREN-3-YL ACETATE
[(3S,10R,13S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate
[(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate
[(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] ethanoate
154229-18-2
17-(3-Pyridyl)-5,16-androstadien-3-b-acetate
17-(3-Pyridyl)-5,16-androstadien-3beta-acetate
17-(3-Pyridyl)androsta-5, acetate
17-(pyridin-3-yl)androsta-5,16-dien-3beta-yl acetate
3|A-acetoxy-17-(3-pyridyl)androsta-5,16-diene
3b-acetoxy-17-(3-pyridyl)androsta-5,16-diene
3beta-17-(3-Pyridyl)androsta-5,16-dien-3-ol Acetate
3beta-Acetoxy-17-(3-pyridyl)androsta-5,16-diene
3S,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-ol, 3-acetate
A809510
AB0032741
AB07697
Abiraterone Acetate
Abiraterone Acotate
Abiraterone (acetate)
Abiraterone Acetate (CB7630)
Abiraterone acetate (JAN/USAN)
Abiraterone acetate [USAN]
Abiraterone acetate, >=98% (HPLC)
Abiraterone acetate, United States Pharmacopeia (USP) Reference Standard
Abiraterone acetate/CB 7630
ABP001055
AC-25760
acetic acid [(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-(3-pyridinyl)-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] ester
ACN-031820
AJ-45666
AKOS015896502
AMX10148
Androsta-5, 17-(3-pyridinyl)-, 3-acetate,
Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, acetate (ester), (3beta)-
BC657179
BCP02949
BDBM50407398
BRD-K24048528-001-02-5
CAS-154229-18-2
CB 7630
CB 7630; JNJ 212082
CB-7630
CB7630
CHEBI:68639
CHEMBL271227
CS-0544
CTK8E7107
D09701
DS-2007
DSSTox_CID_28969
DSSTox_GSID_49043
DSSTox_RID_83234
DTXSID3049043
EBD32544
EM5OCB9YJ6
EX-A107
GTPL9288
HY-75054
I06-2461
JNJ-2012082
MFCD00934213
MLS006010090
MolPort-006-391-496
NCGC00186462-01
NSC-748121
NSC-749227
NSC748121
NSC749227
RT-011150
S-7704
s2246
SC-66343
SCHEMBL93715
SMR004701235
ST24024598
Tox21_113589
UNII-EM5OCB9YJ6
UVIQSJCZCSLXRZ-UBUQANBQSA-N
W-201385
X6144
Yonsa
ZINC3809191
Zytiga
Zytiga (TN)
Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
YONSA TABLET;ORAL abiraterone acetate 210308 2018-07-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2017-08-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2015-04-28

US Patents and Regulatory Information for ABIRATERONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-001 Apr 28, 2011 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharma Global YONSA abiraterone acetate TABLET;ORAL 210308-001 May 22, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global YONSA abiraterone acetate TABLET;ORAL 210308-001 May 22, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amneal Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327-001 Jan 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ABIRATERONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 11C0055 France   Start Trial PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893 2012/003 Ireland   Start Trial PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893 SPC/GB11/063 United Kingdom   Start Trial PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
Johnson and Johnson
Baxter
Express Scripts

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