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ODOMZO Drug Profile
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» See Plans and PricingWhich patents cover Odomzo, and what generic alternatives are available?
Odomzo is a drug marketed by Sun Pharma Global and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and eleven 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.
US ANDA Litigation and 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: | 111 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 5 |
| Patent Applications: | 48 |
| Drug Prices: | Drug price information for ODOMZO |
| DailyMed Link: | ODOMZO at DailyMed |
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 |
|---|---|
| Melanoma Institute Australia | Phase 2 |
| Anne Chang | N/A |
| National Cancer Institute (NCI) | N/A |
Pharmacology for ODOMZO
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for ODOMZO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharma Global | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sun Pharma Global | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2009293444 | Start Trial |
| Netherlands | 300790 | Start Trial |
| South Korea | 20080108343 | Start Trial |
| Portugal | 2021328 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ODOMZO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2021328 | PA2015051 | Lithuania | Start Trial | PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 2021328 | 64/2015 | Austria | Start Trial | PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818 |
| 2021328 | 2015C/059 | Belgium | Start Trial | PRODUCT NAME: SONIDEGIB; AUTHORISATION NUMBER AND DATE: EU/1/15/1030 |
| 2021328 | 122016000001 | Germany | Start Trial | PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
