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Medtronic
Covington
US Department of Justice

Generated: May 19, 2019

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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 five 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
Drug patent expirations by year for ODOMZO
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.

Pharmacology for ODOMZO
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
BCP11860
C26H26F3N3O3.2H3O4P
CHEBI:90864
CHEMBL3137317
CS-1175
D10729
DTXSID90669468
Erismodegib Diphosphate
Erismodegib Diphosphate, NVP-LDE225 (diphosphate salt)
EX-A1556
FE-0016
HY-16582
KS-00002WSZ
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
NVP-LDE225 Diphosphate salt
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)
SB16677
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sun Pharma Global ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Sun Pharma Global ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for ODOMZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2021328 64/2015 Austria ➤ Try a Free Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328 92883 Luxembourg ➤ Try a Free Trial PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818
2021328 15C0077 France ➤ Try a Free Trial PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328 PA2015051 Lithuania ➤ Try a Free Trial PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Medtronic
Deloitte
Covington
US Army
Queensland Health

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