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Last Updated: December 4, 2024

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AKEEGA Drug Patent Profile


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When do Akeega patents expire, and what generic alternatives are available?

Akeega is a drug marketed by Janssen Biotech and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and eighty-six patent family members in fifty-five countries.

The generic ingredient in AKEEGA is abiraterone acetate; niraparib tosylate. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abiraterone acetate; niraparib tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Akeega

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 27, 2038. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for AKEEGA
International Patents:286
US Patents:11
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for AKEEGA
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for AKEEGA
What excipients (inactive ingredients) are in AKEEGA?AKEEGA excipients list
DailyMed Link:AKEEGA at DailyMed
Drug patent expirations by year for AKEEGA
Drug Prices for AKEEGA

See drug prices for AKEEGA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AKEEGA
Generic Entry Date for AKEEGA*:
Constraining patent/regulatory exclusivity:
NDA:
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 AKEEGA

AKEEGA is protected by eleven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKEEGA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AKEEGA

Niraparib compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treating prostate cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

FDA Regulatory Exclusivity protecting AKEEGA

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 ⤷  Sign Up
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No ⤷  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 AKEEGA

When does loss-of-exclusivity occur for AKEEGA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18246214
Patent: Niraparib compositions
Estimated Expiration: ⤷  Sign Up

Patent: 21245223
Patent: Niraparib compositions
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2019020211
Patent: composições de niraparib
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 58375
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 0944638
Patent: 尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1992177
Patent: КОМПОЗИЦИИ НА ОСНОВЕ НИРАПАРИБА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 00314
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9630
Patent: פורמולציות של ניראפריב (Niraparib formulations)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 20512350
Patent: ニラパリブ組成物
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 19011496
Patent: COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201909011P
Patent: NIRAPARIB COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 200014736
Patent: 니라파립 조성물
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 61476
Estimated Expiration: ⤷  Sign Up

Patent: 1840315
Patent: NIRAPARIB compositions
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AKEEGA around the world.

Country Patent Number Title Estimated Expiration
Nicaragua 201900009 Mà TODOS PARA TRATAR EL Cà NCER DE PRà STATA Se describen métodos para tratar el c ⤷  Sign Up
Dominican Republic P2009000170 INDAZOLES SUSTITUIDOS CON AMIDA COMO INHIBIDORES DE POLI(ADP-RIBOSA) POLIMERASA (PARP) ⤷  Sign Up
Japan 5545690 ⤷  Sign Up
Taiwan I528961 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AKEEGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2240466 18C1020 France ⤷  Sign Up PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608 667 Finland ⤷  Sign Up
1633724 13/2015 Austria ⤷  Sign Up PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
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
>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.