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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Serving leading biopharmaceutical companies globally:

McKinsey
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Colorcon
Merck
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Johnson and Johnson

Last Updated: December 14, 2019

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ABIRATERONE ACETATE Drug Profile

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When do Abiraterone Acetate patents expire, and what generic alternatives are available?

Abiraterone Acetate is a drug marketed by Amneal Pharms, Apotex Inc, Glenmark Pharms, Hikma Pharms, Msn Labs Pvt Ltd, Mylan, Qilu Pharm Co Ltd, Rising, Teva Pharms Usa, and Wockhardt Bio Ag. and is included in ten NDAs.

The generic ingredient in ABIRATERONE ACETATE 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.

US ANDA Litigation and Generic Entry Outlook for Abiraterone Acetate

A generic version of ABIRATERONE ACETATE was launched as abiraterone acetate by APOTEX INC on December 14th, 2019.

Drug patent expirations by year for ABIRATERONE ACETATE
Drug Prices for ABIRATERONE ACETATE

See drug prices for ABIRATERONE ACETATE

Recent Clinical Trials for ABIRATERONE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

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

See all ABIRATERONE ACETATE clinical trials

Recent Litigation for ABIRATERONE ACETATE

Identify potential future generic entrants

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
Amneal Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327-001 Jan 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Qilu Pharm Co Ltd ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 212462-001 Sep 27, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208339-001 Oct 31, 2018 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

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Merck

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