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Last Updated: July 6, 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 patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline 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 forty-one patent family members in fifty countries.

One supplier is listed for this compound.

Summary for niraparib tosylate
International Patents:241
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 34
Clinical Trials: 1
Patent Applications: 7
DailyMed Link:niraparib tosylate at DailyMed
Recent Clinical Trials for niraparib tosylate

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
University of California, DavisPhase 2
Janssen, LPPhase 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
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   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
1633724 C01633724/01 Switzerland   Start Trial PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724 92680 Luxembourg   Start Trial PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
1633724 13/2015 Austria   Start Trial PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2109608 CA 2018 00017 Denmark   Start Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; 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:

AstraZeneca
Moodys
Harvard Business School
Johnson and Johnson
Baxter
Merck

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