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Last Updated: May 26, 2022

ODOMZO Drug Patent Profile


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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

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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
Drug patent expirations by year for ODOMZO
Drug Prices for ODOMZO

See drug prices for ODOMZO

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

SponsorPhase
Gruppo Oncologico del Nord-OvestPhase 2
Melanoma Institute AustraliaPhase 2
Anne ChangPhase 2

See all ODOMZO clinical trials

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Harvard Business School
AstraZeneca
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.