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ODOMZO Drug Patent Profile

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When do Odomzo patents expire, and when can generic versions of Odomzo launch?

Odomzo is a drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and eighteen patent family members in forty-nine 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.

DrugPatentWatch^® Generic Entry Outlook for Odomzo

Odomzo was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ODOMZO

International Patents:	118
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	6
Patent Applications:	583
Drug Prices:	Drug price information for ODOMZO
What excipients (inactive ingredients) are in ODOMZO?	ODOMZO excipients list
DailyMed Link:	ODOMZO at DailyMed

Drug patent expirations by year for ODOMZO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ODOMZO

Generic Entry Date for ODOMZO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for ODOMZO

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

Sponsor	Phase
Gruppo Oncologico del Nord-Ovest	Phase 2
Melanoma Institute Australia	Phase 2
Anne Chang	Phase 2

See all ODOMZO clinical trials

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for ODOMZO

ODOMZO is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ODOMZO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ODOMZO

Crystaline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-Methyl-4'-(trifluo- romethoxy) [1,1'-biphenyl]-3-Methanamide monophosphate, and process of preparation thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(t- rifluoromethoxy)[1,1'-biphenyl]-3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compounds and compositions as hedgehog pathway modulators
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BASAL CELL CARCINOMA

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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 ODOMZO

When does loss-of-exclusivity occur for ODOMZO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

Patent: 5906616
Patent: LDE225单磷酸盐的晶型及其制备方法 (Crystal form of LED 225 monophosphate and preparation method thereof)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 79198
Patent: FORME CRISTALLINE DU MONOPHOSPHATE DE N-[6-(FORME CIS-2,6-DIMÉTHYLMORPHOLINE-GROUPE-4)PYRIDINE-GROUPE-3]-2-MÉTHYL-4'-(TRIFLUOROMÉTHOXY)[1,1'-BIPHÉNYL]-3-FORMAMIDE ET SON PROCÉDÉ DE PRÉPARATION (CRYSTAL FORM OF N-[6-(CIS FORM-2,6-DIMETHYLMORPHOLINE-4-GROUP)PYRIDINE-3- GROUP]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3- FORMAMIDE MONOPHOSPHATE, AND PREPARATION METHOD THEREFOR)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ODOMZO around the world.

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Country	Patent Number	Title	Estimated Expiration
Norway	341889		⤷ Sign Up
Luxembourg	92883		⤷ Sign Up
South Africa	200808962	Compounds and compositions as hedgehog pathway modulators	⤷ Sign Up
South Korea	101076943		⤷ Sign Up
Honduras	2008001652	COMPUESTO Y COMPOSICIONES COMO MODULARES DE LA SENDA DE HEDGEHOG	⤷ Sign Up
Norway	20171395	Forbindelser og sammensetninger som pinnsvin reaksjonsvei modulatorer	⤷ Sign Up
Denmark	2021328		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ODOMZO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	SPC/GB15/079	United Kingdom	⤷ Sign Up	PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/15/1030/001-002 20150818; UK (C(2015)5890) 20150818
2021328	CA 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
2021328	2015C/059	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
2021328	255 5026-2015	Slovakia	⤷ Sign Up	FORMER OWNER: NOVARTIS AG, CH
2021328	2015/055	Ireland	⤷ Sign Up	PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/15/1030(C(2015)5890 20150818
2021328	92883	Luxembourg	⤷ Sign Up	PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 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