Details for New Drug Application (NDA): 202429
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NDA 202429 describes ZELBORAF, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZELBORAF profile page.
The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
Summary for 202429
| Tradename: | ZELBORAF |
| Applicant: | Hoffmann La Roche |
| Ingredient: | vemurafenib |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202429
Generic Entry Date for 202429*:
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: 202429
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 202429
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZELBORAF | vemurafenib | TABLET;ORAL | 202429 | NDA | Genentech, Inc. | 50242-090 | 50242-090-02 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 240MG | ||||
| Approval Date: | Aug 17, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 22, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 20, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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