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Last Updated: November 15, 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 six 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
Drug Prices for ODOMZO

See drug prices 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.

Recent Clinical Trials for ODOMZO

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

SponsorPhase
Melanoma Institute AustraliaPhase 2
Anne ChangN/A
National Cancer Institute (NCI)N/A

See all ODOMZO clinical trials

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

Supplementary Protection Certificates for ODOMZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2021328 300790 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2021328 C02021328/01 Switzerland   Start Trial PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: SWISSMEDIC 65065 30.06.2015
2021328 PA2015051,C2021328 Lithuania   Start Trial PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328 CR 2015 00057 Denmark   Start Trial 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   Start Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Moodys
Mallinckrodt
Harvard Business School
Baxter

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