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 |
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.
Pharmacology for AKEEGA
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 |