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ZYTIGA Drug Profile
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 twenty-nine 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. Seven suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for ZYTIGA
International Patents: | 29 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 63 |
Clinical Trials: | 70 |
Patent Applications: | 59 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZYTIGA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZYTIGA |
DailyMed Link: | ZYTIGA at DailyMed |

Pharmacology for ZYTIGA
Drug Class | Cytochrome P450 17A1 Inhibitor |
Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors |
Medical Subject Heading (MeSH) Categories for ZYTIGA
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 |
(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 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 |
AJ-45666 |
AK-92306 |
AKOS015896502 |
AMX10148 |
Androsta-5, 17-(3-pyridinyl)-, 3-acetate, |
Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, acetate (ester), (3beta)- |
BC657179 |
BDBM50407398 |
CAS-154229-18-2 |
CB 7630 |
CB-7630 |
CB7630 |
CB7630 ACETATE |
CHEBI:68639 |
CHEMBL271227 |
CS-0544 |
CTK8E7107 |
D06CNP |
D09701 |
DS-2007 |
DSSTox_CID_28969 |
DSSTox_GSID_49043 |
DSSTox_RID_83234 |
DTXSID3049043 |
EBD32544 |
EM5OCB9YJ6 |
EX-A107 |
GTPL9288 |
HY-75054 |
I06-2461 |
JNJ-2012082 |
JNJ-212082 |
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) |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-002 | Apr 14, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for ZYTIGA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for ZYTIGA
Drugname | Dosage | Strength | RLD | Date |
---|---|---|---|---|
➤ Subscribe | Tablets | 500 mg | ➤ Subscribe | ➤ Sign Up |
➤ Subscribe | Tablets | 250 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for ZYTIGA
Country | Document Number | Estimated Expiration |
---|---|---|
New Zealand | 597830 | ➤ Sign Up |
South Korea | 20180003636 | ➤ Sign Up |
Israel | 227746 | ➤ Sign Up |
Croatia | P20130961 | ➤ Sign Up |
Japan | 2012082215 | ➤ Sign Up |
Spain | 2428634 | ➤ Sign Up |
Australia | 2015221447 | ➤ Sign Up |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ZYTIGA
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
12/003 | Ireland | ➤ Sign Up | 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 |
C0055 | France | ➤ Sign Up | 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 |
C/GB11/063 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |