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Last Updated: February 20, 2020

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Niraparib tosylate - Generic Drug Details

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

Niraparib tosylate is the generic ingredient in one branded drug marketed by Tesaro Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and thirty-nine patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for niraparib tosylate
International Patents:239
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 32
Clinical Trials: 1
Patent Applications: 7
DailyMed Link:niraparib tosylate at DailyMed
Recent Clinical Trials for niraparib tosylate

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SponsorPhase
Janssen, LPPhase 2
National Cancer Institute (NCI)Phase 2
University of California, DavisPhase 2

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

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
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tesaro Inc ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for niraparib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 2018016 Norway   Start Trial PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127
1633724 13/2015 Austria   Start Trial PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 15C0022 France   Start Trial PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
1633724 2015/016 Ireland   Start Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 PA2015016 Lithuania   Start Trial PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
2109608 CR 2018 00017 Denmark   Start Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic

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