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Last Updated: November 7, 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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for niraparib tosylate
Generic Entry Dates for niraparib tosylate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for niraparib tosylate*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Ohio State University Comprehensive Cancer CenterPhase 2
Oregon Health and Science UniversityPhase 1
Eli Lilly and CompanyPhase 1

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 TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Country Patent Number Title Estimated Expiration
Australia 2004220321 Phthalazinone derivatives ⤷  Sign Up
Hong Kong 1182016 抑制 活性的 用於生產治療癌症的藥物的用途 (USE OF RNAI INHIBITING PARP ACTIVTIY FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER PARP RNAI) ⤷  Sign Up
Denmark 1649017 ⤷  Sign Up
United Kingdom 0327844 ⤷  Sign Up
Ecuador SP099484 INDAZOLES SUSTITUIDOS CON AMIDA COMO INHIBIDORES DE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for niraparib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 2018016 Norway ⤷  Sign Up PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127
2109608 2018C/017 Belgium ⤷  Sign Up 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
1633724 13/2015 Austria ⤷  Sign Up PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2109608 PA2018009 Lithuania ⤷  Sign Up PRODUCT NAME: NIRAPAARIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, STEREOIZOMERAS ARBA TAUTOMERAS, BUTENT TOSILATAS ARBA HIDRATAS, YPATINGAI TOSILATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 18C1019 France ⤷  Sign Up PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
>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.