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Last Updated: April 27, 2024

Niraparib tosylate - Generic Drug Details

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What are the generic 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

Generic Entry Dates for niraparib tosylate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;ORAL
Generic Entry Dates for niraparib tosylate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for niraparib tosylate

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

US Patents and Regulatory Information for niraparib tosylate

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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
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for niraparib tosylate

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Country	Patent Number	Title	Estimated Expiration
South Korea	20090097191	AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE(PARP) INHIBITORS	⤷ Try a Trial
Mexico	2019011496	COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.)	⤷ Try a Trial
Serbia	51780	INDAZOLI SUPSTITUISANI AMIDOM KAO INHIBITORI POLI(ADP-RIBOZA)POLIMERAZE (PARP) (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS)	⤷ Try a Trial
Australia	2018341479	Niraparib formulations	⤷ Try a Trial
Norway	2018016		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for niraparib tosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	2015/016	Ireland	⤷ Try a Trial	PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2109608	2018/019	Ireland	⤷ Try a Trial	PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE.; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608	18/2018	Austria	⤷ Try a Trial	PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 (MITTEILUNG) 20171120
2109608	C201830023	Spain	⤷ Try a Trial	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
1633724	13/2015	Austria	⤷ Try a Trial	PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.