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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 four patent family members in forty-seven 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.

Summary for ODOMZO

International Patents:	104
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	20
Clinical Trials:	4
Drug Prices:	Drug price information for ODOMZO
DailyMed Link:	ODOMZO at DailyMed

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.

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Synonyms for ODOMZO

(1,1'-Biphenyl)-3-carboxamide, N-(6-((2R,6S)-2,6-dimethyl-4-morpholinyl)-3-pyridinyl)-2-methyl-4'-(trifluoromethoxy)-, rel-, phosphate (1:2)

1218778-77-8

3888AH

AKOS015994565

AOB87343

C26H26F3N3O3.2H3O4P

CHEBI:90864

CHEMBL3137317

CS-1175

D10729

DTXSID90669468

Erismodegib Diphosphate, NVP-LDE225 (diphosphate salt)

EX-A1556

FE-0016

HY-16582

KS-00002WSZ

LDE 225 Diphosphate;NVP-LDE 225 Diphosphate;Erismodegib Diphosphate;LDE-225 Diphosphate

LDE-225 Diphosphate

LDE225 (Diphosphate)

LDE225 Diphosphate

MolPort-009-194-128

N-(6-((2R,6S)-2,6-Dimethylmorpholino)pyridin-3-yl)-2-methyl-4'-(trifluoromethoxy)-[1,1'-biphenyl]-3-carboxamide bis(phosphate)

NVP-LDE225 Diphosphate

Odomzo (TN)

Phosphoric acid--N-{6-[(2R,6S)-2,6-dimethylmorpholin-4-yl]pyridin-3-yl}-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide (2/1)

rel-N-{6-[(2R,6S)-2,6-dimethylmorpholin-4-yl]pyridin-3-yl}-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide bis(phosphate)

sonidegib bisphosphate

sonidegib diphosphate

Sonidegib phosphate

Sonidegib phosphate (USAN)

Sonidegib phosphate [USAN:INN]

UNII-W421AI34UW

W-6021

W421AI34UW

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	Document Number	Estimated Expiration
Morocco	30426
Mexico	2011002805
Lithuania	C2021328
Canada	2736751

Supplementary Protection Certificates for ODOMZO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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
15/055	Ireland		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/15/1030(C(2015)5890 20150818
2016000001	Germany		PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814