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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.
Generic Entry Opportunity Date for 205266
*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 |
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|
|Regulatory Exclusivity Expiration:||Jul 24, 2020|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||➤ Sign Up||Patent Expiration:||Sep 15, 2029||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patent:||➤ Sign Up||Patent Expiration:||Feb 6, 2029||Product Flag?||Substance Flag?||Y||Delist Request?|
|Patented Use:||TREATMENT OF BASAL CELL CARCINOMA|
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