Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Last Updated: November 11, 2019

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Sonidegib phosphate - Generic Drug Details

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What are the generic drug sources for sonidegib phosphate and what is the scope of freedom to operate?

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

Sonidegib phosphate has one hundred and six patent family members in forty-seven countries.

There are two drug master file entries for sonidegib phosphate. One supplier is listed for this compound.

Summary for sonidegib phosphate
International Patents:106
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 25
Clinical Trials: 2
DailyMed Link:sonidegib phosphate at DailyMed
Recent Clinical Trials for sonidegib phosphate

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

SponsorPhase
Senhwa Biosciences, Inc.Phase 1
National Cancer Institute (NCI)N/A
Anne ChangN/A

See all sonidegib phosphate clinical trials

Pharmacology for sonidegib phosphate
Synonyms for sonidegib phosphate
(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 (USAN)
Sonidegib phosphate [USAN:INN]
UNII-W421AI34UW
W-6021
W421AI34UW

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 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   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
>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 sonidegib phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 300790 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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 64/2015 Austria   Start Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328 15C0077 France   Start Trial PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Harvard Business School
Mallinckrodt
Dow
Medtronic

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