ODOMZO Drug Patent Profile
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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 |


DrugPatentWatch® Estimated 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
Sponsor | Phase |
---|---|
Gruppo Oncologico del Nord-Ovest | Phase 2 |
Melanoma Institute Australia | Phase 2 |
Anne Chang | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ODOMZO
US Patents and Regulatory Information for ODOMZO
ODOMZO is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ODOMZO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compounds and compositions as hedgehog pathway modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BASAL CELL CARCINOMA
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>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:
Argentina
Patent: 3591
Estimated Expiration: See Plans and Pricing
Patent: 3778
Estimated Expiration: See Plans and Pricing
Australia
Patent: 09293444
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0918629
Estimated Expiration: See Plans and Pricing
Patent: 2020009045
Estimated Expiration: See Plans and Pricing
Canada
Patent: 36751
Estimated Expiration: See Plans and Pricing
Chile
Patent: 11000551
Estimated Expiration: See Plans and Pricing
China
Patent: 2159570
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 51744
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 110126
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0130597
Estimated Expiration: See Plans and Pricing
Cuba
Patent: 860
Estimated Expiration: See Plans and Pricing
Patent: 110055
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 14097
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 42198
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 011000082
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 11010985
Estimated Expiration: See Plans and Pricing
El Salvador
Patent: 11003857
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 0048
Estimated Expiration: See Plans and Pricing
Patent: 1100501
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 42198
Estimated Expiration: See Plans and Pricing
Georgia, Republic of
Patent: 0125592
Estimated Expiration: See Plans and Pricing
Honduras
Patent: 11000745
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 56628
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1412
Estimated Expiration: See Plans and Pricing
Japan
Patent: 97938
Estimated Expiration: See Plans and Pricing
Patent: 12097104
Estimated Expiration: See Plans and Pricing
Patent: 12502912
Estimated Expiration: See Plans and Pricing
Jordan
Patent: 89
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 1100
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 11002805
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 717
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 1420
Estimated Expiration: See Plans and Pricing
Nicaragua
Patent: 1100051
Estimated Expiration: See Plans and Pricing
Peru
Patent: 110292
Estimated Expiration: See Plans and Pricing
Poland
Patent: 42198
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 42198
Estimated Expiration: See Plans and Pricing
San Marino
Patent: 01300072
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 42198
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1101579
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1129088
Estimated Expiration: See Plans and Pricing
Patent: 110056325
Estimated Expiration: See Plans and Pricing
Patent: 120015363
Estimated Expiration: See Plans and Pricing
Spain
Patent: 18485
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 67883
Estimated Expiration: See Plans and Pricing
Patent: 1016686
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 11000092
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 3049
Estimated Expiration: See Plans and Pricing
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 | See Plans and Pricing |
Cyprus | 1114097 | See Plans and Pricing | |
Spain | 2418485 | See Plans and Pricing | |
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) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ODOMZO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2021328 | 300790 | Netherlands | See Plans and Pricing | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2021328 | SPC/GB15/079 | United Kingdom | See Plans and Pricing | 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 | See Plans and Pricing | 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 | See Plans and Pricing | 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 |