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 |
Oregon Health and Science University | Phase 1 |
Eli Lilly and Company | 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 | ⤷ 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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