Details for New Drug Application (NDA): 208573
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NDA 208573 describes VENCLEXTA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the VENCLEXTA profile page.
The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.
The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.
Summary for 208573
| Tradename: | VENCLEXTA |
| Applicant: | Abbvie |
| Ingredient: | venetoclax |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208573
Generic Entry Date for 208573*:
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: 208573
| Mechanism of Action | P-Glycoprotein Inhibitors |
| Physiological Effect | Increased Cellular Death |
Suppliers and Packaging for NDA: 208573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENCLEXTA | venetoclax | TABLET;ORAL | 208573 | NDA | AbbVie Inc. | 0074-0561 | 0074-0561-11 | 1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| VENCLEXTA | venetoclax | TABLET;ORAL | 208573 | NDA | AbbVie Inc. | 0074-0561 | 0074-0561-14 | 1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 11, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY | ||||||||
| Regulatory Exclusivity Expiration: | May 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
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