SONIDEGIB PHOSPHATE - Generic Drug Details

What are the generic sources for sonidegib phosphate and what is the scope of patent protection?

Sonidegib phosphate is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sonidegib phosphate has one hundred and eighteen patent family members in forty-nine countries.

There is one drug master file entry for sonidegib phosphate. One supplier is listed for this compound.

Summary for SONIDEGIB PHOSPHATE

International Patents:	118
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	2
Patent Applications:	72
DailyMed Link:	SONIDEGIB PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SONIDEGIB PHOSPHATE

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 SONIDEGIB PHOSPHATE

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

Sponsor	Phase
Senhwa Biosciences, Inc.	Phase 1
Novartis Pharmaceuticals	Phase 2
National Cancer Institute (NCI)	Phase 2

See all SONIDEGIB PHOSPHATE clinical trials

Pharmacology for SONIDEGIB PHOSPHATE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for SONIDEGIB PHOSPHATE

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	Y
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

International Patents for SONIDEGIB PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Ukraine	103049	СОЛІ N-[6-ЦИС-2,6-ДИМЕТИЛМОРФОЛІН-4-ІЛ)ПІРИДИН-3-ІЛ]-2-МЕТИЛ-4'-(ТРИФТОРМЕТОКСИ)[1,1'-ДИФЕНІЛ]-3-КАРБОКСАМІДУ[СОЛИ N-[6-ЦИС-2,6-ДИМЕТИЛМОРФОЛИН-4-ИЛ)ПИРИДИН-3-ИЛ]-2-МЕТИЛ-4'-(ТРИФТОРМЕТОКСИ)[1,1'-ДИФЕНИЛ]-3-КАРБОКСАМИДА (SALTS OF N-[6-CIS-2,6-DIMETHYLMORPHOLIN-4YL)PYRIDINE-3YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3-CARBOXAMIDE)
Argentina	060858	COMPUESTOS Y COMPOSICIONES COMO MODULADORES DE LA SENDA DE HEDGEHOG
Russian Federation	2413718	СОЕДИНЕНИЯ И КОМПОЗИЦИИ В КАЧЕСТВЕ МОДУЛЯТОРОВ ПУТИ HEDGEHOG (COMPOUNDS AND COMPOSITIONS AS MODULATORS OF HEDGEHOG PATHWAY)
South Korea	20120015363	SALTS OF N-[6-CIS-2,6-DIMETHYLMORPHOLIN-4-YL)PYRIDINE-3-YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3-CARBOXAMIDE
Taiwan	I367883
China	102159570	Salts of n-[6-cis-2,6-dimethylmorpholin-4yl)pyridine-3yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide
Brazil	PI0918629	sal de n-[6-cis-2,6-dimetilmorfolin-4-il]piridina-3-il]-2-metil-4'-(trifluormetóxi)[1-1'-bifenil]-3-carboxcamida e composição farmacêutica

Supplementary Protection Certificates for SONIDEGIB PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	C02021328/01	Switzerland		VERTRETERLOESCHUNG
2021328	PA2015051	Lithuania		PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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	15C0077	France		PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION 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	658	Finland