Incivek is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 2 drug patents are active and 1 has expired. Incivek's patents have been open to challenges since 24 May, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be May 30, 2028. Details of Incivek's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7820671 | Peptidomimetic protease inhibitors |
Feb, 2025
(5 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8529882 | Peptidomimetic protease inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
| US8431615 | Dose forms |
May, 2028
(3 years 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 Incivek's patents.
Latest Legal Activities on Incivek's Patents
Given below is the list of recent legal activities going on the following patents of Incivek.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 03 Dec, 2018 | US7820671 |
| Maintenance Fee Reminder Mailed Critical | 11 Jun, 2018 | US7820671 |
| Expire Patent Critical | 09 Oct, 2017 | US8529882 |
| Expire Patent Critical | 26 May, 2017 | US8431615 |
| Patent Term Extension Certificate Critical | 18 Mar, 2016 | US7820671 |
| Notice of Final Determination -Eligible | 15 Dec, 2015 | US7820671 |
| FDA Final Eligibility Letter Critical | 21 Jan, 2015 | US7820671 |
| Post Issue Communication - Certificate of Correction | 15 Oct, 2014 | US8431615 |
| Mail-Petition Decision - Dismissed Critical | 25 Jul, 2014 | US8431615 |
| Petition Decision - Dismissed Critical | 25 Jul, 2014 | US8431615 |
FDA has granted several exclusivities to Incivek. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Incivek, 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 Incivek.
Exclusivity Information
Incivek holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Incivek's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 23, 2016 |
US patents provide insights into the exclusivity only within the United States, but Incivek 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 Incivek's family patents as well as insights into ongoing legal events on those patents.
Incivek's Family Patents
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Generic Launch
Generic Release Date:
Incivek's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 30, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Incivek Generics:
There are no approved generic versions for Incivek as of now.
About Incivek
Incivek is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating chronic hepatitis C. Incivek uses Telaprevir as an active ingredient. Incivek was launched by Vertex Pharms in 2011.
Approval Date:
Incivek was approved by FDA for market use on 23 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 Incivek is 23 May, 2011, its NCE-1 date is estimated to be 24 May, 2015.
Active Ingredient:
Incivek uses Telaprevir as the active ingredient. Check out other Drugs and Companies using Telaprevir ingredient
Treatment:
Incivek is used for treating chronic hepatitis C.
Dosage:
Incivek is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 375MG | TABLET | Discontinued | ORAL |