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 thirteen patents protecting this drug.
This drug has three hundred and fourteen patent family members in fifty-seven 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, 2031. This may change due to patent challenges or generic licensing.
There have been ten 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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Questions you can ask:
- What is the 5 year forecast for AKEEGA?
- What are the global sales for AKEEGA?
- What is Average Wholesale Price for AKEEGA?
Summary for AKEEGA
| International Patents: | 314 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AKEEGA |
US Patents and Regulatory Information for AKEEGA
AKEEGA is protected by twenty-two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKEEGA is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
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:
Argentina
Patent: 4777
Estimated Expiration: ⤷ Start Trial
Austria
Patent: 02933
Estimated Expiration: ⤷ Start 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 |
|---|---|---|---|
| Norway | 2018016 | ⤷ Start Trial | |
| South Africa | 200507097 | Phthalazinone derivatives | ⤷ Start Trial |
| Lithuania | PA2025528 | ⤷ Start Trial | |
| Japan | 2009079056 | PHTHALAZINONE DERIVATIVE | ⤷ Start Trial |
| Mexico | 337421 | 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.) | ⤷ Start Trial |
| Japan | 2024150638 | ⤷ Start Trial | |
| Croatia | P20250157 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AKEEGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3490560 | 122025000033 | Germany | ⤷ Start Trial | PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON INSBESONDERE NIRAPARIBTOSYLAT INSBESONDERE NIRAPARIBTOSYLAT-MONOHYDRAT, GEGEBENENFALLS IN KOMBINATION MIT ABIRATERON INSBESONDERE ABIRATERONACETAT.; REGISTRATION NO/DATE: EU/1/23/1722 20230419 |
| 0633893 | SPC/GB11/063 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905 |
| 3490560 | C20250026 | Finland | ⤷ Start Trial | |
| 2240466 | 132018000000301 | Italy | ⤷ Start Trial | PRODUCT NAME: NIRAPARIB TOSILATO O UN SUO IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120 |
| 2240466 | 18C1020 | France | ⤷ Start Trial | 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 | 300937 | Netherlands | ⤷ Start Trial | 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 | 132018000000263 | Italy | ⤷ Start Trial | PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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