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ODOMZO Drug Profile
Which 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 four patent family members in forty-seven 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.
Summary for ODOMZO
| International Patents: | 104 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 20 |
| Clinical Trials: | 4 |
| Drug Prices: | Drug price information for ODOMZO |
| DailyMed Link: | ODOMZO at DailyMed |
Generic Entry Opportunity Date for ODOMZO
*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.
Pharmacology for ODOMZO
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
Synonyms for ODOMZO
| (1,1'-Biphenyl)-3-carboxamide, N-(6-((2R,6S)-2,6-dimethyl-4-morpholinyl)-3-pyridinyl)-2-methyl-4'-(trifluoromethoxy)-, rel-, phosphate (1:2) |
| 1218778-77-8 |
| 3888AH |
| AKOS015994565 |
| AOB87343 |
| C26H26F3N3O3.2H3O4P |
| CHEBI:90864 |
| CHEMBL3137317 |
| CS-1175 |
| D10729 |
| DTXSID90669468 |
| Erismodegib Diphosphate, NVP-LDE225 (diphosphate salt) |
| EX-A1556 |
| FE-0016 |
| HY-16582 |
| KS-00002WSZ |
| LDE 225 Diphosphate;NVP-LDE 225 Diphosphate;Erismodegib Diphosphate;LDE-225 Diphosphate |
| LDE-225 Diphosphate |
| LDE225 (Diphosphate) |
| LDE225 Diphosphate |
| MolPort-009-194-128 |
| N-(6-((2R,6S)-2,6-Dimethylmorpholino)pyridin-3-yl)-2-methyl-4'-(trifluoromethoxy)-[1,1'-biphenyl]-3-carboxamide bis(phosphate) |
| NVP-LDE225 Diphosphate |
| Odomzo (TN) |
| Phosphoric acid--N-{6-[(2R,6S)-2,6-dimethylmorpholin-4-yl]pyridin-3-yl}-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide (2/1) |
| rel-N-{6-[(2R,6S)-2,6-dimethylmorpholin-4-yl]pyridin-3-yl}-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide bis(phosphate) |
| sonidegib bisphosphate |
| sonidegib diphosphate |
| Sonidegib phosphate |
| Sonidegib phosphate (USAN) |
| Sonidegib phosphate [USAN:INN] |
| UNII-W421AI34UW |
| W-6021 |
| W421AI34UW |
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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Sun Pharma Global | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sun Pharma Global | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 101129088 | ➤ Sign Up |
| Cuba | 20080202 | ➤ Sign Up |
| San Marino | AP200800056 | ➤ Sign Up |
| Singapore | 172680 | ➤ Sign Up |
| Israel | 194818 | ➤ Sign Up |
| Mexico | 2008014190 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ODOMZO
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0077 | France | ➤ Sign Up | PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 883 | Luxembourg | ➤ Sign Up | PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818 |
| 2016000001 | Germany | ➤ Sign Up | PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814 |
| 2015 00057 | Denmark | ➤ Sign Up | PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818 |
| 2015051,C2021328 | Lithuania | ➤ Sign Up | PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 0790 | Netherlands | ➤ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
