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*:
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
Sponsor | Phase |
---|---|
Ohio State University Comprehensive Cancer Center | Phase 2 |
National Cancer Institute (NCI) | Phase 1 |
OHSU Knight Cancer Institute | Phase 1 |
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
US Patents and Regulatory Information for niraparib tosylate
International Patents for niraparib tosylate
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 | |
Brazil | PI0412899 | composto para inibir a atividade de parp, usos de uma quantidade terapêutica e uma quantidade terapeuticamente efetiva de um composto e de seus sais farmaceuticamente aceitáveis, uso de um composto, composição farmacêutica, e, método para o tratamento de cáncer em mamìferos | ⤷ Try a Trial |
Germany | 602004025123 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for niraparib tosylate
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 |
2109608 | LUC00072 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, STEREOISOMERE OU TAUTOMERE DE CELUI-CI, NOTAMMENT LE TOSYLATE OU UN HYDRATE, PARTICULIEREMENT LE TOSYLATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120 |
2240466 | 122018000052 | Germany | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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