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Last Updated: November 2, 2024

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate; niraparib tosylate has two hundred and eighty-six patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for abiraterone acetate; niraparib tosylate
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.

US Patents and Regulatory Information 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 216793-002 Aug 11, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 abiraterone acetate; niraparib tosylate

Country Patent Number Title Estimated Expiration
Hong Kong 1079530 Phthalazinone derivatives ⤷  Sign Up
South Africa 201003902 PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3-YL]PHENYL}-2H-INDAZOLE-7-CARBOXAMIDE ⤷  Sign Up
Japan 2007516241 ⤷  Sign Up
>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 PA2015016,C1633724 Lithuania ⤷  Sign Up PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 122015000025 Germany ⤷  Sign Up PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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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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.