ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - Generic Drug Details

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What are the generic drug 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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate; niraparib tosylate has two hundred and eighty-six patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

International Patents:	286
US Patents:	11
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Drug Class	Cytochrome P450 17A1 Inhibitor Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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Glossary

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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	Y	Y		⤷ 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
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	⤷ 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 ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Japan	4611441		⤷ Sign Up
Mexico	2009007200	INDAZOLES SUSTITUIDOS CON AMIDA COMO INHIBIDORES DE POLI(ADP-RIBOSA)POLIMERASA (PARP). (AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS.)	⤷ Sign Up
Austria	E502933		⤷ Sign Up
Cyprus	1111584		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008084261		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	1590019-4	Sweden	⤷ Sign Up	PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	2015C/024	Belgium	⤷ Sign Up	PRODUCT NAME: OLAPARIB ET LES SELS ET SOLVATES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20141218
2109608	132018000000263	Italy	⤷ Sign Up	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
1633724	C 2015 011	Romania	⤷ Sign Up	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
2240466	C201830027	Spain	⤷ Sign Up	PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
>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.

Summary for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Pharmacology for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE