erivedge Drug Patent Profile
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When do Erivedge patents expire, and what generic alternatives are available?
Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-four patent family members in twenty-four countries.
The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.
DrugPatentWatch® Generic Entry Outlook for Erivedge
Erivedge was eligible for patent challenges on January 30, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for erivedge
International Patents: | 54 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 46 |
Patent Applications: | 1,341 |
Drug Prices: | Drug price information for erivedge |
What excipients (inactive ingredients) are in erivedge? | erivedge excipients list |
DailyMed Link: | erivedge at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for erivedge
Generic Entry Date for erivedge*:
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 erivedge
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Genentech, Inc. | Early Phase 1 |
H. Lee Moffitt Cancer Center and Research Institute | Early Phase 1 |
Ronald Buckanovich | Phase 2 |
Pharmacology for erivedge
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for erivedge
erivedge is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of erivedge is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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 erivedge
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 erivedge
See the table below for patents covering erivedge around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2013219216 | Pyridyl Inhibitors of Hedgehog Signalling | ⤷ Subscribe |
Canada | 2579002 | INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING) | ⤷ Subscribe |
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) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for erivedge
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1789390 | C20130027 00083 | Estonia | ⤷ Subscribe | PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013 |
1789390 | C01789390/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013 |
1789390 | 132013902210830 | Italy | ⤷ Subscribe | PRODUCT NAME: VISMODEGIB(ERIVEDGE); AUTHORISATION NUMBER(S) AND DATE(S): 62497, 20130530;EU/1/13/848, 20130712 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Erivedge Market Analysis and Financial Projection Experimental
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