ZYTIGA Drug Patent 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.

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.

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Summary for ZYTIGA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	115
Patent Applications:	1,604
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

Drug patent expirations by year for ZYTIGA

Recent Clinical Trials for ZYTIGA

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

Sponsor	Phase
Orion Corporation, Orion Pharma	Phase 3
Merck Sharp & Dohme LLC	Phase 3
Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3

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

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	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

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ZYTIGA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ZYTIGA

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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1131577	COMPOSITIONS FOR TREATING CANCER	⤷ Sign Up
Germany	69327096		⤷ Sign Up
Germany	69416419		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZYTIGA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	2012/003	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
0633893	CA 2011 00035	Denmark	⤷ Sign Up
0633893	11C0055	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description