~ Buy the AKEEGA (abiraterone acetate; niraparib tosylate) Drug Profile, 2024 PDF Report in the Report Store ~

AKEEGA Drug Patent Profile

When do Akeega patents expire, and what generic alternatives are available?

Akeega is a drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and eighty-five patent family members in fifty-five countries.

The generic ingredient in AKEEGA is abiraterone acetate; niraparib tosylate. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abiraterone acetate; niraparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Akeega

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 27, 2038. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AKEEGA

International Patents:	285
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AKEEGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AKEEGA
What excipients (inactive ingredients) are in AKEEGA?	AKEEGA excipients list
DailyMed Link:	AKEEGA at DailyMed

See drug prices for AKEEGA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AKEEGA

NDA:

216793

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AKEEGA

Drug Class	Cytochrome P450 17A1 Inhibitor Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AKEEGA

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

US Patents and Regulatory Information for AKEEGA

AKEEGA is protected by eight US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AKEEGA

FDA Regulatory Exclusivity protecting AKEEGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y
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	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y

International Patents for AKEEGA

When does loss-of-exclusivity occur for AKEEGA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Singapore

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AKEEGA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2009532452
Mexico	2019011496	COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.)
Poland	2336120
Mexico	2019001224	METODOS PARA TRATAR EL CANCER DE PROSTATA. (METHODS OF TREATING PROSTATE CANCER.)
Montenegro	03481	INDAZOLI SUPSTITUISANI AMIDOM KAO INHIBITORI POLI(ADP-RIBOZA)POLIMERAZE (PARP) (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS)
Austria	516353

Supplementary Protection Certificates for AKEEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	213 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2109608	18C1019	France		PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	667	Finland
2109608	LUC00072	Luxembourg		PRODUCT NAME: NIRAPARIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, STEREOISOMERE OU TAUTOMERE DE CELUI-CI, NOTAMMENT LE TOSYLATE OU UN HYDRATE, PARTICULIEREMENT LE TOSYLATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120
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
2109608	300937	Netherlands		PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120