Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
Cerilliant
Daiichi Sankyo
Cantor Fitzgerald
Healthtrust
Express Scripts
Medtronic
Fuji

Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205266

« Back to Dashboard

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
Tradename:ODOMZO
Applicant:Sun Pharma Global
Ingredient:sonidegib phosphate
Patents:2
Generic Entry Opportunity 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
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 Pharma Global FZE 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:➤ Sign UpPatent Expiration:Sep 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Feb 6, 2029Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF BASAL CELL CARCINOMA

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
Accenture
McKinsey
McKesson
Deloitte
Colorcon
US Department of Justice
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.