Details for New Drug Application (NDA): 219616
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NDA 219616 describes AVMAPKI FAKZYNJA CO-PACK (COPACKAGED), which is a drug marketed by Verastem Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) profile page.
The generic ingredient in AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) is avutometinib potassium; defactinib hydrochloride. One supplier is listed for this compound. Additional details are available on the avutometinib potassium; defactinib hydrochloride profile page.
The generic ingredient in AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) is avutometinib potassium; defactinib hydrochloride. One supplier is listed for this compound. Additional details are available on the avutometinib potassium; defactinib hydrochloride profile page.
Summary for 219616
| Tradename: | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) |
| Applicant: | Verastem Inc |
| Ingredient: | avutometinib potassium; defactinib hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219616
Generic Entry Date for 219616*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE, 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: 219616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | avutometinib potassium; defactinib hydrochloride | CAPSULE, TABLET;ORAL | 219616 | NDA | Verastem Inc. | 71779-623 | 71779-623-01 | 1 KIT in 1 CARTON (71779-623-01) * 24 CAPSULE in 1 BOTTLE (71779-660-02) * 42 TABLET in 1 BOTTLE (71779-630-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, TABLET;ORAL | Strength | EQ 0.8MG BASE;EQ 200MG BASE | ||||
| Approval Date: | May 8, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 8, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 29, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH DEFACTINIB | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 11, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH AVUTOMETINIB | ||||||||
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