Erivedge is a drug owned by Genentech Inc. It is protected by 3 US drug patents filed from 2013 to 2021 out of which none have expired yet. Erivedge's patents have been open to challenges since 31 January, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 15, 2028. Details of Erivedge's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7888364 | Pyridyl inhibitors of hedgehog signalling |
Nov, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9278961 | Pyridyl inhibitors of hedgehog signalling |
Dec, 2028
(4 years from now) | Active |
| US9790183 | Pyridyl inhibitors of hedgehog signalling |
Sep, 2025
(9 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Erivedge's patents.
Latest Legal Activities on Erivedge's Patents
Given below is the list of recent legal activities going on the following patents of Erivedge.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Aug, 2023 | US9278961 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Aug, 2022 | US7888364 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Mar, 2021 | US9790183 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Aug, 2019 | US9278961 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2018 | US7888364 |
| Mail O.P. Petition Decision | 11 May, 2018 | US9790183 |
| Mail-Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 09 May, 2018 | US9790183 |
| O.P. Petition Decision | 08 May, 2018 | US9790183 |
| Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 08 May, 2018 | US9790183 |
| Post Issue Communication - Certificate of Correction | 08 Nov, 2017 | US9790183 |
FDA has granted several exclusivities to Erivedge. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Erivedge, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Erivedge.
Exclusivity Information
Erivedge holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Erivedge's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 30, 2017 |
US patents provide insights into the exclusivity only within the United States, but Erivedge is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Erivedge's family patents as well as insights into ongoing legal events on those patents.
Erivedge's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Erivedge's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 15, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Erivedge Generics:
There are no approved generic versions for Erivedge as of now.
About Erivedge
Erivedge is a drug owned by Genentech Inc. It is used for treating basal cell carcinoma and cancer in mammals. Erivedge uses Vismodegib as an active ingredient. Erivedge was launched by Genentech in 2012.
Approval Date:
Erivedge was approved by FDA for market use on 30 January, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Erivedge is 30 January, 2012, its NCE-1 date is estimated to be 31 January, 2016.
Active Ingredient:
Erivedge uses Vismodegib as the active ingredient. Check out other Drugs and Companies using Vismodegib ingredient
Treatment:
Erivedge is used for treating basal cell carcinoma and cancer in mammals.
Dosage:
Erivedge is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | CAPSULE | Prescription | ORAL |