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 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
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: | 806 |
| Drug Prices: | Drug price information for ODOMZO |
| What excipients (inactive ingredients) are in ODOMZO? | ODOMZO excipients list |
| DailyMed Link: | ODOMZO at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Gruppo Oncologico del Nord-Ovest | Phase 2 |
| Melanoma Institute Australia | Phase 2 |
| Anne Chang | Phase 2 |
Pharmacology for ODOMZO
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 | |
| Japan | 2012017333 | COMPOUND AND COMPOSITION AS HEDGEHOG PATHWAY MODULATOR | ⤷ Try a Trial |
| Costa Rica | 10399 | COMPUESTOS Y COMPOSICIONES COMO MODULADORES DE LA SENDA DE HEDGEHOG | ⤷ Try a Trial |
| Norway | 341215 | ⤷ Try a Trial | |
| Poland | 2021328 | ⤷ Try a Trial | |
| Australia | 2007247860 | Compounds and compositions as hedgehog pathway modulators | ⤷ 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 | 658 | Finland | ⤷ Try a Trial | |
| 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 | 2015C/059 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| 2021328 | PA2015051 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 2021328 | 300790 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2021328 | PA2015051,C2021328 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; 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
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.
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