Details for New Drug Application (NDA): 203388
✉ Email this page to a colleague
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: | ⤷ Sign Up | Patent Expiration: | Nov 11, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 2, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA |
Complete Access Available with Subscription