VISMODEGIB - Generic Drug Details
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What are the generic drug sources for vismodegib and what is the scope of patent protection?
Vismodegib
is the generic ingredient in one branded drug marketed by Genentech and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vismodegib has fifty-four patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for VISMODEGIB
International Patents: | 54 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 77 |
Patent Applications: | 3,554 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in VISMODEGIB? | VISMODEGIB excipients list |
DailyMed Link: | VISMODEGIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VISMODEGIB
Generic Entry Date for VISMODEGIB*:
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 VISMODEGIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sun Pharmaceutical Industries Limited | Phase 2 |
Genentech, Inc. | Early Phase 1 |
H. Lee Moffitt Cancer Center and Research Institute | Early Phase 1 |
Pharmacology for VISMODEGIB
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for VISMODEGIB
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for VISMODEGIB
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Erivedge | vismodegib | EMEA/H/C/002602 Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy |
Authorised | no | no | no | 2013-07-12 | 2013-04-26 |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VISMODEGIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101366414 | ⤷ Try a Trial | |
Australia | 2021205133 | Pyridyl inhibitors of hedgehog signalling | ⤷ Try a Trial |
South Korea | 20150002863 | PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING | ⤷ Try a Trial |
Eurasian Patent Organization | 017262 | СОЕДИНЕНИЯ 2-(2-ГАЛОГЕН-4-АМИНОФЕНИЛ)ПИРИДИНОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ (COMPOUNDS OF 2-(2-HALOGEN-4-AMINOPHENYL)PYRIDYL INHIBITORS OF HEDGEHOG SIGNALING (EMBODIMENTS), PROCESS FOR PREPARING SAME, COMPOSITION AND METHODS FOR TREATING CANCER AND INHIBITING ANGIOGENESIS AND HEDGEHOG PATHWAY SIGNALING IN CELLS BASED THEREON) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VISMODEGIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1789390 | 14C0002 | France | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB AINSI QUE SES SELS ET SOLVATES; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: IKS 62497 20130530 |
1789390 | 92278 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ERIVEDGE ); AUTHORISATION NUMBER AND DATE: 62497 |
1789390 | 132013902210830 | Italy | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB(ERIVEDGE); AUTHORISATION NUMBER(S) AND DATE(S): 62497, 20130530;EU/1/13/848, 20130712 |
1789390 | C 2013 038 | Romania | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB SI SARURILE SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/848; DATE OF NATIONAL AUTHORISATION: 20130712; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 62497 01; DATE OF FIRST AUTHORISATION IN EEA: 20130530 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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