NIRAPARIB TOSYLATE - Generic Drug Details
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What are the generic drug 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 |
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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | DISCN | 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 | 214876-003 | Apr 26, 2023 | RX | Yes | Yes | ⤷ 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 | Y | ⤷ Try a Trial | |||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
|---|---|---|---|
| Russian Federation | 2006105652 | ТРИЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ПАРП | ⤷ Try a Trial |
| European Patent Office | 2109608 | INDAZOLES À SUBSTITUTION AMIDE UTILISÉS COMME INHIBITEURS DE LA POLY(ADP-RIBOSE)POLYMÉRASE (PARP) (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS) | ⤷ Try a Trial |
| Israel | 173336 | נגזרות של אפסילון-לקטם המאוחה עם אינדול ובנזאימידאזול לטיפול בסרטן הנגרם על-ידי פגם גנטי בגן (Pericondensed derivatives of ɛ-lactam with indole and benzimidazole for treating cancer caused by a genetic defect in a gene) | ⤷ Try a Trial |
| Japan | 2020512350 | ニラパリブ組成物 | ⤷ Try a Trial |
| Australia | 2021245223 | Niraparib compositions | ⤷ Try a Trial |
| United Kingdom | 0305681 | ⤷ 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 | 596 | Finland | ⤷ Try a Trial | |
| 1633724 | S1500012 | Hungary | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB |
| 1633724 | C20150012 00136 | Estonia | ⤷ Try a Trial | PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014 |
| 2240466 | C201830027 | 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 | 667 | Finland | ⤷ Try a Trial | |
| 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 |
| >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.
ISSN: 2162-2639
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