ZYTIGA Drug Patent Profile

When do Zytiga patents expire, and when can generic versions of Zytiga launch?

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zytiga

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

Summary for ZYTIGA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	111
Patent Applications:	2,018
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZYTIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYTIGA
What excipients (inactive ingredients) are in ZYTIGA?	ZYTIGA excipients list
DailyMed Link:	ZYTIGA at DailyMed

See drug prices for ZYTIGA

Recent Clinical Trials for ZYTIGA

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

Sponsor	Phase
MacroGenics	Phase 2/Phase 3
Australian and New Zealand Urogenital and Prostate Cancer Trials Group	Phase 2
Anticancer Fund, Belgium	Phase 2

See all ZYTIGA clinical trials

Pharmacology for ZYTIGA

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

Anatomical Therapeutic Chemical (ATC) Classes for ZYTIGA

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ZYTIGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYTIGA	Tablets	abiraterone acetate	500 mg	202379	1	2017-08-23
ZYTIGA	Tablets	abiraterone acetate	250 mg	202379	13	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
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	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

EU/EMA Drug Approvals for ZYTIGA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Abiraterone Mylan	abiraterone acetate	EMEA/H/C/005368 Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.	Authorised	yes	no	no	2021-08-20
Krka, d.d., Novo mesto	Abiraterone Krka	abiraterone acetate	EMEA/H/C/005649 Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.	Authorised	yes	no	no	2021-06-24

International Patents for ZYTIGA

See the table below for patents covering ZYTIGA around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	9305269
Hong Kong	1131577	COMPOSITIONS FOR TREATING CANCER
Spain	2138618

Supplementary Protection Certificates for ZYTIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	91911	Luxembourg		91911, EXPIRES: 20180315
0633893	CA 2011 00035	Denmark
0633893	C00633893/01	Switzerland		PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011