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Last Updated: July 12, 2020

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Details for New Drug Application (NDA): 205266

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NDA 205266 describes ODOMZO, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ODOMZO profile page.

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
Applicant:Sun Pharma Global
Ingredient:sonidegib phosphate
Generic Entry Opportunity Date for 205266
Generic Entry Date for 205266*:
Constraining patent/regulatory exclusivity:

*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
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 47335-303-83 30 CAPSULE in 1 BOTTLE (47335-303-83)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Jul 24, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 24, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Feb 6, 2029Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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