Abiraterone acetate; niraparib tosylate - Generic Drug Details
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What are the generic sources for abiraterone acetate; niraparib tosylate and what is the scope of freedom to operate?
Abiraterone acetate; niraparib tosylate
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Abiraterone acetate; niraparib tosylate has two hundred and eighty-five patent family members in fifty-five countries.
One supplier is listed for this compound.
Summary for abiraterone acetate; niraparib tosylate
| International Patents: | 285 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for abiraterone acetate; niraparib tosylate |
| DailyMed Link: | abiraterone acetate; niraparib tosylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abiraterone acetate; niraparib tosylate
Generic Entry Date for abiraterone acetate; niraparib tosylate*:
Constraining patent/regulatory exclusivity:
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 abiraterone acetate; niraparib tosylate
| 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 | 216793-002 | 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 | Y | Y | ⤷ 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 | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | Y | Y | ⤷ 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 abiraterone acetate; niraparib tosylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2009532452 | ⤷ Try a Trial | |
| Mexico | 2019011496 | COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.) | ⤷ Try a Trial |
| Poland | 2336120 | ⤷ Try a Trial | |
| Mexico | 2019001224 | METODOS PARA TRATAR EL CANCER DE PROSTATA. (METHODS OF TREATING PROSTATE CANCER.) | ⤷ Try a Trial |
| Montenegro | 03481 | INDAZOLI SUPSTITUISANI AMIDOM KAO INHIBITORI POLI(ADP-RIBOZA)POLIMERAZE (PARP) (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS) | ⤷ Try a Trial |
| Austria | 516353 | ⤷ Try a Trial | |
| China | 1856313 | Therapeutic compounds | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for abiraterone acetate; niraparib tosylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | 213 50005-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218 |
| 2109608 | 18C1019 | France | ⤷ Try a Trial | 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 |
| 2109608 | 667 | Finland | ⤷ Try a Trial | |
| 2109608 | LUC00072 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, STEREOISOMERE OU TAUTOMERE DE CELUI-CI, NOTAMMENT LE TOSYLATE OU UN HYDRATE, PARTICULIEREMENT LE TOSYLATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120 |
| 0633893 | 2012/003 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905 |
| 2109608 | 300937 | Netherlands | ⤷ Try a 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 | 1890020-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/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.
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