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ZYTIGA Drug Profile

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Which patents cover Zytiga, and what generic alternatives are available?

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-five patent family members in nineteen countries.

The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Zytiga

A generic version of ZYTIGA was approved as abiraterone acetate by APOTEX on October 31^st, 2018.

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Summary for ZYTIGA

International Patents:	35
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	67
Clinical Trials:	80
Patent Applications:	64
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

Drug patent expirations by year for ZYTIGA

Recent Clinical Trials for ZYTIGA

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

Sponsor	Phase
Oregon Health and Science University	Phase 2
National Cancer Institute (NCI)	Phase 3
NRG Oncology	Phase 3

See all ZYTIGA clinical trials

Recent Litigation for ZYTIGA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
BTG INTERNATIONAL LIMITED v. QILU PHARMACEUTICAL CO., LTD.	2018-11-28
BTG INTERNATIONAL LIMITED v. MSN PHARMACEUTICALS INC.	2018-02-20
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.	2016-11-30

See all ZYTIGA litigation

PTAB Litigation

Petitioner	Date
	2017-02-08
Wockhardt Bio AG	2016-08-10
Mylan Pharmaceuticals Inc.	2016-06-30

See all ZYTIGA litigation

Pharmacology for ZYTIGA

Drug Class	Cytochrome P450 17A1 Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors

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)-3-Acetoxy-17-(pyridin-3-yl)androsta-5,16-diene
[(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
Abiraterone-Acetate-CB7630
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
AKOS015896502
AMX10148
Androsta-5, 17-(3-pyridinyl)-, 3-acetate,
Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, acetate (ester), (3beta)-
BCP02949
BDBM50407398
BRD-K24048528-001-02-5
CAS-154229-18-2
CB 7630
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
JNJ 212082
JNJ-2012082
MFCD00934213
MLS006010090
NCGC00186462-01
NSC-748121
NSC-749227
NSC748121
NSC749227
Q27888393
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

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Glossary

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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

Expired US Patents for ZYTIGA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ZYTIGA

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Country	Patent Number	Estimated Expiration
Denmark	0721461	Start Trial
South Korea	100235135	Start Trial
Australia	2015221447	Start Trial
Spain	2127413	Start Trial
Spain	2428634	Start Trial
Portugal	2061561	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ZYTIGA

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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	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	91911	Luxembourg	Start Trial	91911, EXPIRES: 20180315
0633893	CA 2011 00035	Denmark	Start Trial
0633893	1190040-4	Sweden	Start Trial	PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description