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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 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. Six 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:	68
Patent Applications:	58
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

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis 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

(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
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	AB	RX	Yes	No
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017		RX	Yes	Yes
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017		RX	Yes	Yes

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

Paragraph IV (Patent) Challenges for ZYTIGA

Drugname	Dosage	Strength	RLD	Date
	Tablets	500 mg
	Tablets	250 mg

International Patents for ZYTIGA

Country	Document Number	Estimated Expiration
European Patent Office	2061561
European Patent Office	2478907
Japan	2015110577
Cyprus	1115477
Japan	6053279

Supplementary Protection Certificates for ZYTIGA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0055	France		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
12/003	Ireland		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
C/GB11/063	United Kingdom		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905