Vismodegib - Generic Drug Details
✉ Email this page to a colleague
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-three patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for vismodegib
| International Patents: | 53 |
| 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 |
|---|---|---|---|
| Australia | 2011201229 | Pyridyl Inhibitors of Hedgehog Signalling | ⤷ Try a Trial |
| Mexico | 2007002584 | INHIBIDORES DE PIRIDILO DE SENALIZACION DE HEDGEHOG. (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING.) | ⤷ Try a Trial |
| China | 101072755 | Pyridyl inhibitors of hedgehog signalling | ⤷ Try a Trial |
| Luxembourg | 92278 | ⤷ Try a Trial | |
| Japan | 2008511675 | ⤷ 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 | 92278 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ERIVEDGE ); AUTHORISATION NUMBER AND DATE: 62497 |
| 1789390 | CA 2013 00050 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530 |
| 1789390 | 2013C/071 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB; AUTHORISATION NUMBER AND DATE: EU/1/13/84/001 20130715 |
| 1789390 | 122013000074 | Germany | ⤷ Try a Trial | PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530 |
| 1789390 | 514 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
