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ODOMZO Drug Patent Profile

When do Odomzo patents expire, and what generic alternatives are available?

Odomzo is a drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and eighteen 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 March 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ODOMZO

International Patents:	118
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	6
Patent Applications:	806
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 Loss of Exclusivity (LOE) 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
Gruppo Oncologico del Nord-Ovest	Phase 2
Melanoma Institute Australia	Phase 2
Anne Chang	Phase 2

See all ODOMZO clinical trials

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ODOMZO

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ODOMZO

ODOMZO is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ODOMZO

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

International Patents for ODOMZO

When does loss-of-exclusivity occur for ODOMZO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ODOMZO around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	172680	COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS
Canada	2736751	SELS DE N-[6-(CIS-2,6-DIMETHYLMORPHOLIN-4-YL)PYRIDIN-3-YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)-[1,1'-BIPHENYL]-3-CARBOXAMIDE (SALTS OF N-[6-(CIS-2,6-DIMETHYLMORPHOLIN-4-YL)PYRIDINE-3-YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3-CARBOXAMIDE)
Hong Kong	1127043	COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS
South Korea	101129088
Japan	4891396
Brazil	PI0711333	compostos e composições como moduladores da via hedgehog
Norway	341215

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	SPC/GB15/079	United Kingdom		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/15/1030/001-002 20150818; UK (C(2015)5890) 20150818
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	92883	Luxembourg		PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818
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	122016000001	Germany		PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
2021328	15C0077	France		PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT