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Last Updated: July 8, 2020

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ODOMZO Drug Profile


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Which patents cover Odomzo, and what generic alternatives are available?

Odomzo is a drug marketed by Sun Pharma Global and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and eleven patent family members in forty-nine countries.

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.

US ANDA Litigation and Generic Entry Outlook for Odomzo

Odomzo was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 15, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ODOMZO
Drug patent expirations by year for ODOMZO
Drug Prices for ODOMZO

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Generic Entry Opportunity Date for ODOMZO
Generic Entry Date for ODOMZO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for ODOMZO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Melanoma Institute AustraliaPhase 2
Anne ChangN/A
National Cancer Institute (NCI)N/A

See all ODOMZO clinical trials

Pharmacology for ODOMZO

US Patents and Regulatory Information for ODOMZO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sun Pharma Global ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ODOMZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2021328 PA2015051 Lithuania   Start Trial PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328 64/2015 Austria   Start Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328 2015C/059 Belgium   Start Trial PRODUCT NAME: SONIDEGIB; AUTHORISATION NUMBER AND DATE: EU/1/15/1030
2021328 122016000001 Germany   Start Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Harvard Business School
AstraZeneca
Medtronic

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 verification 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.