Sonidegib phosphate - Generic Drug Details
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What are the generic sources for sonidegib phosphate and what is the scope of freedom to operate?
Sonidegib phosphate
is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sonidegib phosphate has one hundred and eighteen patent family members in forty-nine countries.
There is one drug master file entry for sonidegib phosphate. One supplier is listed for this compound.
Summary for sonidegib phosphate
International Patents: | 118 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 2 |
Patent Applications: | 72 |
DailyMed Link: | sonidegib phosphate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for sonidegib phosphate
Generic Entry Date for sonidegib phosphate*:
Constraining patent/regulatory exclusivity:
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 sonidegib phosphate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Senhwa Biosciences, Inc. | Phase 1 |
National Cancer Institute (NCI) | Phase 2 |
Anne Chang | Phase 2 |
Pharmacology for sonidegib phosphate
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for sonidegib phosphate
US Patents and Regulatory Information for sonidegib phosphate
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 | 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 | ⤷ 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 sonidegib phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201101579 | SALTS OF N-[6-CIS-2,6-DIMETHYLMORPHOLIN-4YL)PYRIDINE-3YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3-CARBOXAMIDE | ⤷ Try a Trial |
Chile | 2007001269 | COMPUESTOS DERIVADOS DE HETEROCICLOS DE NITROGENO, MODULADORES DE VIAS DE HEDGEHOG; Y USO PARA EL TRATAMIENTO DE CANCER PANCREATICO, CANCER DE PROSTATA, MEDULOBLASTOMA, CARCINOMA CELULAR BASAL Y CANCER PULMONAR DE CELULA PEQUENA. | ⤷ Try a Trial |
Nicaragua | 201100051 | SALES DE N - [ 6 - ( CIS - 2, 6 - DIMETIL - MORFOLIN - 4 - IL ) - PIRIDIN - 3 - IL ] - 2 - METIL - 4' - ( TRIFLUORO - METOXI ) - [ 1, 1' - BIFENIL] - 3 - CARBOXAMIDA. | ⤷ Try a Trial |
Lithuania | PA2015051 | ⤷ Try a Trial | |
Australia | 2007247860 | Compounds and compositions as hedgehog pathway modulators | ⤷ Try a Trial |
Jordan | 2883 | مركبات وتركيبات على شكل معدلات للممرات القنفذية (Compounds And Compositions As Hedgehog Pathway Modulators) | ⤷ Try a Trial |
Japan | 2012017333 | COMPOUND AND COMPOSITION AS HEDGEHOG PATHWAY MODULATOR | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sonidegib phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2021328 | 2015C/059 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
2021328 | 658 | Finland | ⤷ Try a Trial | |
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 |
2021328 | 300790 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2021328 | SPC/GB15/079 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ 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 | C02021328/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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