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Mallinckrodt
Moodys

Generated: June 24, 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 abiraterone acetate patent protection?

Abiraterone acetate is the generic ingredient in three branded drugs marketed by Amneal Pharms, Apotex Inc, Hikma Pharms, Mylan, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharma Global, and Janssen Biotech, and is included in nine 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 sixty-nine patent family members in thirty-one countries.

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

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)

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
Wockhardt Bio Ag ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208380-001 Feb 27, 2019 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-001 Apr 28, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-001 Apr 28, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208446-001 Oct 31, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hikma Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208339-001 Oct 31, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Supplementary Protection Certificates for ABIRATERONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 2012/003 Ireland ➤ Try a Free 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 ➤ Try a Free Trial PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
0633893 11C0055 France ➤ Try a Free 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Harvard Business School
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