ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - Generic Drug Details

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

Abiraterone acetate; niraparib tosylate is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate; niraparib tosylate has two hundred and eighty-five patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

International Patents:	285
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
DailyMed Link:	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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 ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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

US Patents and Regulatory Information for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes			Y	Y
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	216793-002	Aug 11, 2023		RX	Yes	Yes			Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y

International Patents for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Portugal	1649017
Taiwan	200505871	Phthalazinone derivatives
Mexico	2010006593	SALES FARMACEUTICAMENTE ACEPTABLES DE 2-{4-[(3S)-PIPERIDIN-3-IL]FE NIL}-2H-INDAZOL-7-CARBOXAMIDA. (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE.)
Canada	2711491	SELS PHARMACEUTIQUEMENT ACCEPTABLES DE 2-{4-[(35)-PIPERIDIN-3-YL]PHENYL)-2H-INDAZOLE-7-CARBOXAMIDE (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE)
Croatia	P20190972

Supplementary Protection Certificates for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	SPC/GB18/018	United Kingdom		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 20171120
1633724	213 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
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
2109608	2018C/017	Belgium		PRODUCT NAME: NIRAPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, STEREOISOMEER OF TAUTOMEER, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120
2240466	2018/020	Ireland		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116