NIRAPARIB TOSYLATE - Generic Drug Details

What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and eighty patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for NIRAPARIB TOSYLATE

International Patents:	280
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	3
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIRAPARIB TOSYLATE
DailyMed Link:	NIRAPARIB TOSYLATE at DailyMed

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

Dosage:

CAPSULE;ORAL

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.

Recent Clinical Trials for NIRAPARIB TOSYLATE

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2
National Cancer Institute (NCI)	Phase 1
OHSU Knight Cancer Institute	Phase 1

See all NIRAPARIB TOSYLATE clinical trials

Pharmacology for NIRAPARIB TOSYLATE

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for NIRAPARIB TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No			Y

International Patents for NIRAPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005012305
Japan	7269227
China	102935230	Use of RNAi inhibiting PARP activtiy for the manufacture of a medicament for the treatment of cancer
World Intellectual Property Organization (WIPO)	2004080976
Russian Federation	2495035	ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СОЛИ 2-{4-[(3S)-ПИПЕРИДИН-3-ИЛ]ФЕНИЛ}-2Н-ИНДАЗОЛ-7-КАРБОКСАМИДА (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3-YL]PHENYL}-2H-INDAZOLE-7-CARBOXAMIDE)

Supplementary Protection Certificates for NIRAPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2109608	C201830023	Spain		PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
2240466	300938	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
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	C 2015 011	Romania		PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216