Sonidegib phosphate - Generic Drug Details

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What are the generic 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 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

Generic Entry Date for sonidegib phosphate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
National Cancer Institute (NCI)	Phase 2
Anne Chang	Phase 2

See all sonidegib phosphate clinical trials

Pharmacology for sonidegib phosphate

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for sonidegib phosphate

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for sonidegib phosphate

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Glossary

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

International Patents for sonidegib phosphate

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Country	Patent Number	Title	Estimated Expiration
Mexico	2008014190	COMPUESTOS Y COMPOSICIONES COMO MODULADORES DE LA SENDA DE HEDGEHOG. (COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS.)	⤷ Sign Up
Croatia	P20130597		⤷ Sign Up
Taiwan	201016686	Salts of N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sonidegib phosphate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	C02021328/01	Switzerland	⤷ Sign Up	VERTRETERLOESCHUNG
2021328	64/2015	Austria	⤷ Sign Up	PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328	CR 2015 00057	Denmark	⤷ Sign Up	PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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