Details for New Drug Application (NDA): 203388
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NDA 203388 describes ERIVEDGE, which is a drug marketed by Genentech and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ERIVEDGE profile page.
The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.
The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.
Summary for 203388
| Tradename: | ERIVEDGE |
| Applicant: | Genentech |
| Ingredient: | vismodegib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203388
Generic Entry Date for 203388*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 203388
| Mechanism of Action | Smoothened Receptor Antagonists |
Suppliers and Packaging for NDA: 203388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140 | 50242-140-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC |
| ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388 | NDA | Genentech, Inc. | 50242-140 | 50242-140-86 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 30, 2012 | TE: | RLD: | Yes | |||||
| Patent: | 7,888,364 | Patent Expiration: | Nov 11, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 9,278,961 | Patent Expiration: | Dec 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL | ||||||||
| Patent: | 9,790,183 | Patent Expiration: | Sep 2, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA | ||||||||
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