Victrelis is a drug owned by Merck Sharp And Dohme Corp. It is protected by 3 US drug patents filed in 2013. Out of these, 2 drug patents are active and 1 has expired. Victrelis's patents have been open to challenges since 14 May, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 11, 2027. Details of Victrelis'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. | |||
| USRE43298 | Peptides as NS3-serine protease inhibitors of hepatitis C virus |
Dec, 2024
(4 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7772178 | Pharmaceutical formulations and methods of treatment using the same |
Nov, 2027
(2 years from now) | Active |
| US8119602 | Administration of HCV protease inhibitors in combination with food to improve bioavailability |
Mar, 2027
(1 year, 10 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 Victrelis's patents.
Latest Legal Activities on Victrelis's Patents
Given below is the list of recent legal activities going on the following patents of Victrelis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 12 Sep, 2022 | US7772178 |
| Maintenance Fee Reminder Mailed Critical | 28 Mar, 2022 | US7772178 |
| Expire Patent Critical | 30 Mar, 2020 | US8119602 |
| Maintenance Fee Reminder Mailed Critical | 14 Oct, 2019 | US8119602 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2018 | US7772178 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Feb, 2012 | US8119602 |
| Recordation of Patent Grant Mailed Critical | 21 Feb, 2012 | US8119602 |
| Issue Notification Mailed Critical | 01 Feb, 2012 | US8119602 |
| Dispatch to FDC | 03 Jan, 2012 | US8119602 |
| Petition Decision - Dismissed Critical | 22 Dec, 2011 | US8119602 |
FDA has granted several exclusivities to Victrelis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Victrelis, 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 Victrelis.
Exclusivity Information
Victrelis holds 3 exclusivities. All of its exclusivities have expired in 2016. Details of Victrelis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Feb 13, 2016 |
| M(M-126) | Feb 27, 2016 |
| New Chemical Entity Exclusivity(NCE) | May 13, 2016 |
US patents provide insights into the exclusivity only within the United States, but Victrelis 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 Victrelis's family patents as well as insights into ongoing legal events on those patents.
Victrelis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Victrelis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 11, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Victrelis Generics:
There are no approved generic versions for Victrelis as of now.
About Victrelis
Victrelis is a drug owned by Merck Sharp And Dohme Corp. It is used for treating chronic Hepatitis C genotype 1 infection in adult patients with compensated liver disease. Victrelis uses Boceprevir as an active ingredient. Victrelis was launched by Merck Sharp Dohme in 2011.
Approval Date:
Victrelis was approved by FDA for market use on 13 May, 2011.
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 Victrelis is 13 May, 2011, its NCE-1 date is estimated to be 14 May, 2015.
Active Ingredient:
Victrelis uses Boceprevir as the active ingredient. Check out other Drugs and Companies using Boceprevir ingredient
Treatment:
Victrelis is used for treating chronic Hepatitis C genotype 1 infection in adult patients with compensated liver disease.
Dosage:
Victrelis is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | CAPSULE | Discontinued | ORAL |