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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 sonidegib phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
El Salvador | 2011003857 | SALES N-[6-(CIS-2,6-DIMETIL-MORFOLIN-4-IL)- PIRIDIN-3-IL]-2-METIL-4'-(TRIFLUORO-METOXI)-[1,1'-BIFENIL]-3-CARBOXAMIDA. | ⤷ Sign Up |
San Marino | AP200800056 | Composti e composizioni modulatori della via metabolica hedgehog | ⤷ Sign Up |
Malaysia | 153574 | COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS | ⤷ Sign Up |
Cyprus | 2015054 | ⤷ Sign Up | |
Spain | 2418485 | ⤷ Sign Up | |
Georgia, Republic of | P20105103 | COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS | ⤷ Sign Up |
Costa Rica | 20110126 | SALES DE N-[6-(CIS-2,6-DIMETIL-MORFOLIN-4-IL) -PIRIDIN-3-IL] -2-METIL-4'-(TRIFLUORO-METOXI)-[1,1'-BIFENIL]-3-CARBOXAMIDA | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sonidegib phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2021328 | 658 | Finland | ⤷ Sign Up | |
2021328 | 15C0077 | France | ⤷ Sign Up | PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
2021328 | PA2015051 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
2021328 | PA2015051,C2021328 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
2021328 | 92883 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818 |
2021328 | CR 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 |
2021328 | C02021328/01 | Switzerland | ⤷ Sign Up | VERTRETERLOESCHUNG |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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