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.
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: | 11,091,459 | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,207,311 | 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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