ERIVEDGE Drug Patent Profile
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When do Erivedge patents expire, and when can generic versions of Erivedge launch?
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: | 1,329 |
| Formulation / Manufacturing: | see details |
| 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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ERIVEDGE
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
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
When does loss-of-exclusivity occur for ERIVEDGE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05282722
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Patent: 11201229
Patent: Pyridyl Inhibitors of Hedgehog Signalling
Estimated Expiration: ⤷ Sign Up
Patent: 13219216
Patent: Pyridyl Inhibitors of Hedgehog Signalling
Estimated Expiration: ⤷ Sign Up
Patent: 16203958
Patent: Pyridyl Inhibitors of Hedgehog Signalling
Estimated Expiration: ⤷ Sign Up
Patent: 17261491
Patent: Pyridyl Inhibitors of Hedgehog Signalling
Estimated Expiration: ⤷ Sign Up
Patent: 19226273
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Patent: 21205133
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Patent: 23237067
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 32768
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0514841
Patent: inibidores de piridila da sinalização de hedgehog, processo de preparação dos mesmos e composição compreendendo os referidos inibidores
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 79002
Patent: INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1072755
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Patent: 2964294
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 12630
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 89390
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7262
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 0700538
Patent: СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
Estimated Expiration: ⤷ Sign Up
Patent: 1100604
Patent: СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
Estimated Expiration: ⤷ Sign Up
Patent: 1890903
Patent: СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 89390
Patent: INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 300068
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1673
Patent: תרכובות פירידילים מעכבים איתות במסלול hedgehog, תכשירים רוקחיים המכילים אותם, תהליך להכנתם ושימוש בהם להכנת תרופה לטיפול בסרטן (Pyridyl inhibitors of hedgehog signalling compounds, compositions comprising them, process for their preparation and use of said compounds for the manufacture of medicaments for treatment of cancer in a mammal)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 43558
Estimated Expiration: ⤷ Sign Up
Patent: 08511675
Estimated Expiration: ⤷ Sign Up
Patent: 12184255
Patent: HEDGEHOG SIGNAL TRANSDUCTION PYRIDYL INHIBITOR
Estimated Expiration: ⤷ Sign Up
Patent: 14148537
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 278
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07002584
Patent: INHIBIDORES DE PIRIDILO DE SENALIZACION DE HEDGEHOG. (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9385
Patent: Pyridyl Inhibitors of Hedgehog Signalling
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 9260
Estimated Expiration: ⤷ Sign Up
Patent: 071719
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 89390
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 89390
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 89390
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0702537
Patent: Pyridyl inhibitors of hedgehog signalling
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1225018
Estimated Expiration: ⤷ Sign Up
Patent: 1366414
Estimated Expiration: ⤷ Sign Up
Patent: 070085243
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Patent: 120139846
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Patent: 130083488
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Patent: 140048343
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Patent: 150002863
Patent: PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING
Estimated Expiration: ⤷ Sign Up
Patent: 150090263
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 160058972
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 170001725
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 180122750
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 190072678
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 200019263
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 200118909
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Patent: 210090744
Patent: 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 77430
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 565
Patent: ПИРИДИЛЬНЫЕ ИНГИБИТОРЫ ХЕДЖХОГОВСКОЙ ПЕРЕДАЧИ СИГНАЛА;ПІРИДИЛЬНІ ІНГІБІТОРИ ХЕДЖХОГІВСЬКОЇ ПЕРЕДАЧІ СИГНАЛУ (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ERIVEDGE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 339260 | ⤷ Sign Up | |
| Australia | 2005282722 | Pyridyl inhibitors of hedgehog signalling | ⤷ Sign Up |
| South Korea | 101225018 | ⤷ Sign Up | |
| Japan | 5143558 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERIVEDGE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1789390 | 122013000074 | Germany | ⤷ Sign Up | PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530 |
| 1789390 | 170 12-2013 | Slovakia | ⤷ Sign Up | PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712 |
| 1789390 | C 2013 038 | Romania | ⤷ Sign Up | 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 |
| 1789390 | 1390057-6 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 2025-09-03 - 2028-07-16 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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