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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 fourteen 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.

DrugPatentWatch^® 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

Summary for ODOMZO

International Patents:	114
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	69
Clinical Trials:	5
Patent Applications:	57
Drug Prices:	Drug price information for ODOMZO
What excipients (inactive ingredients) are in ODOMZO?	ODOMZO excipients list
DailyMed Link:	ODOMZO at DailyMed

See drug prices for ODOMZO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ODOMZO

NDA:

205266

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

Sponsor	Phase
Melanoma Institute Australia	Phase 2
Anne Chang	N/A
National Cancer Institute (NCI)	N/A

See all ODOMZO clinical trials

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

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				Y
Sun Pharma Global	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y
Sun Pharma Global	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes

International Patents for ODOMZO

Country	Patent Number	Estimated Expiration
Mexico	2011002805
South Africa	200808962
China	102746285
Nicaragua	201100051
Morocco	30426
San Marino	T201300072

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	122016000001	Germany		PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
2021328	CA 2015 00057	Denmark		PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
2021328	CR 2015 00057	Denmark		PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
2021328	255 5026-2015	Slovakia		FORMER OWNER: NOVARTIS AG, CH
2021328	PA2015051,C2021328	Lithuania		PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	1590062-4	Sweden		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/15/1030 20150818