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 eight patents protecting this drug. Additional details are available on the TRUQAP profile page.
The generic ingredient in TRUQAP is capivasertib. One supplier is listed for this compound. Additional details are available on the capivasertib profile page.
The generic ingredient in TRUQAP is capivasertib. 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: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218197
Generic Entry Date for 218197*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: | Nov 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 16, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 10, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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