ODOMZO Drug Patent Profile

Which patents cover Odomzo, and what generic alternatives are available?

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

This drug has one hundred and fourteen 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 September 15, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ODOMZO

International Patents:	114
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	6
Patent Applications:	822
Drug Prices:	Drug price information for ODOMZO
What excipients (inactive ingredients) are in ODOMZO?	ODOMZO excipients list
DailyMed Link:	ODOMZO at DailyMed

See drug prices for ODOMZO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ODOMZO

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

Anatomical Therapeutic Chemical (ATC) Classes for ODOMZO

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

US Patents and Regulatory Information for ODOMZO

ODOMZO is protected by two US patents.

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

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				Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y

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:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Honduras

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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.

Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	P20125592	SALTS OF N-[6-(CIS-2,6-DIMETHYLMORPHOLIN-4-YL)- PYRIDINE-3-YL]-2-METHYL-4'- (TRIFLUOROMETHOXY)[1,1'- BIPHENYL]-3-CARBOXAMIDE
Cyprus	1114097
Spain	2418485
Eurasian Patent Organization	020048	ДИФОСФАТНАЯ СОЛЬ N-[6-(ЦИС-2,6-ДИМЕТИЛМОРФОЛИН-4-ИЛ)ПИРИДИН-3-ИЛ]-2-МЕТИЛ-4'-(ТРИФТОРМЕТОКСИ)[1,1'-ДИФЕНИЛ]-3-КАРБОКСАМИДА И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (DIPHOSPHATE SALT OF N-[6-(CIS-2,6-DIMETHYLMORPHOLIN-4-YL)PYRIDINE-3-YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-DIPHENYL]-3-CARBOXAMIDE AND PHARMACEUTICAL COMPOSITION)

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2021328	SPC/GB15/079	United Kingdom		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	2015/055	Ireland		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/15/1030(C(2015)5890 20150818
2021328	15C0077	France		PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818