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 eight patents protecting this drug.
This drug has two hundred and eighty-five 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 has been one patent litigation case 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
Summary for AKEEGA
International Patents: | 285 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
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
Anatomical Therapeutic Chemical (ATC) Classes for AKEEGA
US Patents and Regulatory Information for AKEEGA
AKEEGA is protected by eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKEEGA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of treating prostate cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ⤷ 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 | 216793-001 | 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 | ⤷ 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 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
Estimated Expiration: ⤷ Try a Trial
Patent: 21245223
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2019020211
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 58375
Estimated Expiration: ⤷ Try a Trial
China
Patent: 0944638
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1992177
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 00314
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9630
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 20512350
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 19011496
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201909011P
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 200014736
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 61476
Estimated Expiration: ⤷ Try a Trial
Patent: 1840315
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
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 AKEEGA
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 |