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Last Updated: March 29, 2024

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ODOMZO Drug Patent Profile


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Which patents cover Odomzo, 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 seventeen 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:117
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 80
Clinical Trials: 6
Patent Applications: 806
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 Loss of Exclusivity (LOE) 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

Pharmacology for ODOMZO

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds and compositions as hedgehog pathway modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Sun Pharm ODOMZO sonidegib phosphate CAPSULE;ORAL 205266-001 Jul 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 79198
Estimated Expiration: ⤷  Try a Trial

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
Spain 2418485 ⤷  Try a Trial
China 102159570 Salts of n-[6-cis-2,6-dimethylmorpholin-4yl)pyridine-3yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide ⤷  Try a Trial
Slovenia 2021328 ⤷  Try a Trial
South Korea 101076943 ⤷  Try a Trial
Dominican Republic P2011000082 SALES DE N-[6-(CIS-2,6-DIMETIL-MORFOLIN-4-IL)-PIRIDIN-3-IL]-2-METIL-4-(TRIFLUOROMETOXI)-[1,1'-BIFENIL] -3-CARBOXAMIDA ⤷  Try a Trial
Russian Federation 2008147663 СОЕДИНЕНИЯ И КОМПОЗИЦИИ В КАЧЕСТВЕ МОДУЛЯТОРОВ ПУТИ HEDGEHOG ⤷  Try a Trial
Brazil 122020009045 uso de sais de n-[6-cis-2,6-dimetilmorfolin-4-il]piridina-3-il]-2-metil-4'-(trifluormetóxi)[1,1'-bifenil]-3-carboxamida ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ODOMZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2021328 64/2015 Austria ⤷  Try a Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328 2015/055 Ireland ⤷  Try a Trial PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/15/1030(C(2015)5890 20150818
2021328 255 5026-2015 Slovakia ⤷  Try a Trial FORMER OWNER: NOVARTIS AG, CH
2021328 CA 2015 00057 Denmark ⤷  Try a Trial PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
2021328 658 Finland ⤷  Try a Trial
2021328 122016000001 Germany ⤷  Try a Trial PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
2021328 1590062-4 Sweden ⤷  Try a Trial PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/15/1030 20150818
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.