ABIRATERONE ACETATE - Generic Drug Details

What are the generic sources for abiraterone acetate and what is the scope of freedom to operate?

Abiraterone acetate is the generic ingredient in four branded drugs marketed by Amneal Pharms, Apotex, Dr Reddys, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharm, and Janssen Biotech, and is included in eighteen NDAs. There are thirteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has fifty-eight patent family members in twenty-six countries.

There are twenty-two drug master file entries for abiraterone acetate. Twenty-six suppliers are listed for this compound.

Summary for ABIRATERONE ACETATE

International Patents:	58
US Patents:	13
Tradenames:	4
Applicants:	15
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	254
Patent Applications:	3,620
Drug Prices:	Drug price trends for ABIRATERONE ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABIRATERONE ACETATE
What excipients (inactive ingredients) are in ABIRATERONE ACETATE?	ABIRATERONE ACETATE excipients list
DailyMed Link:	ABIRATERONE ACETATE at DailyMed

See drug prices for ABIRATERONE ACETATE

Recent Clinical Trials for ABIRATERONE ACETATE

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

Sponsor	Phase
Changhai Hospital	N/A
Orion Corporation, Orion Pharma	Phase 3
Merck Sharp & Dohme LLC	Phase 3

See all ABIRATERONE ACETATE clinical trials

Pharmacology for ABIRATERONE ACETATE

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

Medical Subject Heading (MeSH) Categories for ABIRATERONE ACETATE

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE

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 ABIRATERONE ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YONSA	Tablets	abiraterone acetate	125 mg	210308	1	2018-07-23
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 ABIRATERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novugen	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947-001	Jan 5, 2022	AB	RX	No	No
Qilu	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	212462-001	Sep 27, 2019	AB	RX	No	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y

Expired US Patents for ABIRATERONE ACETATE

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 ABIRATERONE ACETATE

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 ABIRATERONE ACETATE

Country	Patent Number	Title	Estimated Expiration
Chile	2015002787	Formulación de acetato de abiraterona.
Israel	250270	פורמולציות אבירטרון אצטט ושיטות שימוש (Abiraterone acetate formulation and methods of use)
Japan	2021008521	アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)
South Korea	102121404

Supplementary Protection Certificates for ABIRATERONE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	SPC/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
0633893	2012/003	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
0633893	11C0055	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