Details for New Drug Application (NDA): 219249
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NDA 219249 describes ITOVEBI, which is a drug marketed by Genentech 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 ITOVEBI profile page.
The generic ingredient in ITOVEBI is inavolisib. One supplier is listed for this compound. Additional details are available on the inavolisib profile page.
The generic ingredient in ITOVEBI is inavolisib. One supplier is listed for this compound. Additional details are available on the inavolisib profile page.
Summary for 219249
| Tradename: | ITOVEBI |
| Applicant: | Genentech Inc |
| Ingredient: | inavolisib |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219249
Generic Entry Date for 219249*:
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.
Pharmacology for NDA: 219249
| Mechanism of Action | Phosphoinositide 3-Kinase alpha Inhibitors |
Suppliers and Packaging for NDA: 219249
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ITOVEBI | inavolisib | TABLET;ORAL | 219249 | NDA | Genentech, Inc. | 50242-079 | 50242-079-08 | 1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE |
| ITOVEBI | inavolisib | TABLET;ORAL | 219249 | NDA | Genentech, Inc. | 50242-079 | 50242-079-86 | 1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Oct 10, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 10, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,851,091 | Patent Expiration: | Jul 1, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,028,100 | Patent Expiration: | Apr 26, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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