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Last Updated: November 22, 2019

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ZYTIGA Drug Profile

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Which patents cover Zytiga, and when can generic versions of Zytiga launch?

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in ZYTIGA 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.

Drug patent expirations by year for ZYTIGA
Drug Prices for ZYTIGA

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Recent Clinical Trials for ZYTIGA

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SponsorPhase
Children's Hospital Los AngelesPhase 2
University of MichiganPhase 2
Feinstein Institute for Medical ResearchPhase 2

See all ZYTIGA clinical trials

Recent Litigation for ZYTIGA

Identify potential future generic entrants

District Court Litigation
Case NameDate
BTG INTERNATIONAL LIMITED v. QILU PHARMACEUTICAL CO., LTD.2018-11-28
BTG INTERNATIONAL LIMITED v. MSN PHARMACEUTICALS INC.2018-02-20
BTG INTERNATIONAL LIMITED v. AMERIGEN PHARMACEUTICALS, INC.2016-05-02

See all ZYTIGA litigation

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

See all ZYTIGA litigation

Synonyms for ZYTIGA
(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
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 (TN)
Paragraph IV (Patent) Challenges for ZYTIGA
Tradename Dosage Ingredient NDA Submissiondate
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2017-08-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2015-04-28

US Patents and Regulatory Information for ZYTIGA

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
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 RX Yes Yes   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 ZYTIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Mallinckrodt
Medtronic
Johnson and Johnson
Colorcon

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