Details for New Drug Application (NDA): 216793
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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.
Pharmacology for NDA: 216793
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: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 50MG BASE | ||||
Approval Date: | Aug 11, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 11, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 28, 2037 | Product 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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