akeega Drug Patent Profile
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Which patents cover Akeega, 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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-001 | Aug 11, 2023 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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: ⤷ Subscribe
Patent: 21245223
Patent: Niraparib compositions
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2019020211
Patent: composições de niraparib
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 58375
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
China
Patent: 0944638
Patent: 尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 1992177
Patent: КОМПОЗИЦИИ НА ОСНОВЕ НИРАПАРИБА
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 00314
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 9630
Patent: פורמולציות של ניראפריב (Niraparib formulations)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 20512350
Patent: ニラパリブ組成物
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 19011496
Patent: COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 201909011P
Patent: NIRAPARIB COMPOSITIONS
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 200014736
Patent: 니라파립 조성물
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 61476
Estimated Expiration: ⤷ Subscribe
Patent: 1840315
Patent: NIRAPARIB compositions
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
South Korea | 20060052877 | USE OF RNAI INHIBITING PARP ACTIVITY FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER | ⤷ Subscribe |
Mexico | 2010006593 | SALES FARMACEUTICAMENTE ACEPTABLES DE 2-{4-[(3S)-PIPERIDIN-3-IL]FE NIL}-2H-INDAZOL-7-CARBOXAMIDA. (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE.) | ⤷ Subscribe |
Poland | 2336120 | ⤷ Subscribe | |
China | 110944638 | 尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for akeega
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0633893 | SPC/GB11/063 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 |
1633724 | S1500012 | Hungary | ⤷ Subscribe | PRODUCT NAME: OLAPARIB |
2109608 | 300937 | Netherlands | ⤷ Subscribe | PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120 |
2109608 | 18C1019 | France | ⤷ Subscribe | 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 |
Akeega Market Analysis and Financial Projection Experimental
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