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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216793


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NDA 216793 describes AKEEGA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the AKEEGA profile page.

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.
Summary for 216793
Tradename:AKEEGA
Applicant:Janssen Biotech
Ingredient:abiraterone acetate; niraparib tosylate
Patents:11
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216793
Generic Entry Date for 216793*:
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.

Suppliers and Packaging for NDA: 216793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793 NDA Janssen Biotech, Inc. 57894-050 57894-050-60 1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE
AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793 NDA Janssen Biotech, Inc. 57894-100 57894-100-60 1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 50MG BASE
Approval Date:Aug 11, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 11, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2038Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Jul 28, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

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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.