Abiraterone acetate; niraparib tosylate - Generic Drug Details
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What are the generic sources for abiraterone acetate; niraparib tosylate and what is the scope of freedom to operate?
Abiraterone acetate; niraparib tosylate
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Abiraterone acetate; niraparib tosylate has two hundred and eighty-five patent family members in fifty-five countries.
One supplier is listed for this compound.
Summary for abiraterone acetate; niraparib tosylate
International Patents: | 285 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for abiraterone acetate; niraparib tosylate |
DailyMed Link: | abiraterone acetate; niraparib tosylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abiraterone acetate; niraparib tosylate
Generic Entry Date for abiraterone acetate; 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.
Pharmacology for abiraterone acetate; niraparib tosylate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-001 | Aug 11, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-001 | Aug 11, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-001 | Aug 11, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 abiraterone acetate; niraparib tosylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2021245223 | Niraparib compositions | ⤷ Try a Trial |
Australia | 2004261462 | Tricyclic PARP inhibitors | ⤷ Try a Trial |
Canada | 3058375 | COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS) | ⤷ Try a Trial |
Ecuador | SP099484 | INDAZOLES SUSTITUIDOS CON AMIDA COMO INHIBIDORES DE | ⤷ 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for abiraterone acetate; niraparib tosylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1633724 | C20150012 00136 | Estonia | ⤷ Try a Trial | PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014 |
0633893 | 11C0055 | France | ⤷ Try a Trial | PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905 |
1633724 | 2015/016 | Ireland | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
1633724 | C 2015 011 | Romania | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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