Niraparib tosylate - Generic Drug Details
✉ Email this page to a colleague
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 |
Eli Lilly and Company | Phase 1 |
National Cancer Institute (NCI) | 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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | |||
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 | |||
>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 |
---|---|---|---|
Taiwan | 200836731 | Amide substituted indazoles as poly (ADP-ribose) polymerase (PARP) inhibitors | ⤷ Try a Trial |
South Korea | 20200058496 | 니라파립 제제 | ⤷ Try a Trial |
Brazil | PI0906020 | Sais farmaceuticamente aceitáveis de 2-{4-[ (3s) - piperidina-3-il ] fenil} -2h - indazol - 7 - carboxamida, uso e método de tratamento | ⤷ Try a Trial |
European Patent Office | 2805945 | Indazoles substitués d'amide en tant qu'inhibiteurs PARP de poly(ADP-ribose)polymérase (Amide substituted indazoles as poly(ADP-ribose)polymerase (PARP) inhibitors) | ⤷ 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 |
---|---|---|---|---|
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 |
2109608 | 122018000048 | Germany | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, EINSCHLIESSLICH DES TOSYLATS DAVON; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
1633724 | 122015000025 | Germany | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
2240466 | 2018/020 | Ireland | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.