Details for New Drug Application (NDA): 205266
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The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.
Summary for 205266
Tradename: | ODOMZO |
Applicant: | Sun Pharm |
Ingredient: | sonidegib phosphate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205266
Generic Entry Date for 205266*:
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: 205266
Mechanism of Action | Smoothened Receptor Antagonists |
Suppliers and Packaging for NDA: 205266
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-303 | 47335-303-15 | 30 CAPSULE in 1 BOTTLE (47335-303-15) |
ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-303 | 47335-303-83 | 30 CAPSULE in 1 BOTTLE (47335-303-83) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Jul 24, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 30, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 15, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 24, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patented Use: | TREATMENT OF BASAL CELL CARCINOMA |
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