Details for New Drug Application (NDA): 218197
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NDA 218197 describes TRUQAP, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the TRUQAP profile page.
The generic ingredient in TRUQAP is capivasertib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the capivasertib profile page.
The generic ingredient in TRUQAP is capivasertib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the capivasertib profile page.
Summary for 218197
| Tradename: | TRUQAP |
| Applicant: | Astrazeneca |
| Ingredient: | capivasertib |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218197
Generic Entry Date for 218197*:
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: 218197
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRUQAP | capivasertib | TABLET;ORAL | 218197 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9500 | 0310-9500-01 | 64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01) |
| TRUQAP | capivasertib | TABLET;ORAL | 218197 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9500 | 0310-9500-02 | 4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Nov 16, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 12, 2029 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH ABIRATERONE AND PREDNISONE FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC ANDROGEN PATHWAY MODULATION-NAIVE OR-SENSITIVE PROSTATE CANCER THAT IS PTEN-DEFICIENT AS DETECTED BY AN FDA-AUTHORIZED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Nov 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,039,766 | Patent Expiration: | Apr 16, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT IN COMBINATION WITH ABIRATERONE AND PREDNISONE OF METASTATIC ANDROGEN PATHWAY MODULATION-NAIVE OR -SENSITIVE (MAPMN/S) PROSTATE CANCER THAT IS PTEN-DEFICIENT | ||||||||
Expired US Patents for NDA 218197
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197-002 | Nov 16, 2023 | 9,006,430 | ⤷ Start Trial |
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197-001 | Nov 16, 2023 | 8,809,336 | ⤷ Start Trial |
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197-002 | Nov 16, 2023 | 8,809,336 | ⤷ Start Trial |
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197-001 | Nov 16, 2023 | 9,006,430 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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