Trilipix is a drug owned by Abbvie Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 07, 2025. Details of Trilipix'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. | |||
| US7259186 | Salts of fenofibric acid and pharmaceutical formulations thereof |
Jan, 2025
(9 months ago) |
Expired
|
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 Trilipix's patents.
Latest Legal Activities on Trilipix's Patents
Given below is the list of recent legal activities going on the following patents of Trilipix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jan, 2019 | US7259186 |
| Recordation of Patent Grant Mailed
Critical | 21 Aug, 2007 | US7259186 |
| Patent Issue Date Used in PTA Calculation
Critical | 21 Aug, 2007 | US7259186 |
| Issue Notification Mailed
Critical | 01 Aug, 2007 | US7259186 |
| Application Is Considered Ready for Issue
Critical | 21 Jun, 2007 | US7259186 |
| Dispatch to FDC | 21 Jun, 2007 | US7259186 |
| Issue Fee Payment Verified
Critical | 19 Jun, 2007 | US7259186 |
| Issue Fee Payment Received
Critical | 19 Jun, 2007 | US7259186 |
| Electronic Review
Critical | 13 Jun, 2007 | US7259186 |
| Email Notification
Critical | 12 Jun, 2007 | US7259186 |
FDA has granted several exclusivities to Trilipix. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Trilipix, 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
Trilipix.
Exclusivity Information
Trilipix holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Trilipix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 15, 2011 |
US patents provide insights into the exclusivity only within the United States, but
Trilipix 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 Trilipix's family patents as well as insights into
ongoing legal events
on those patents.
Trilipix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trilipix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 07, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trilipix Generic API suppliers:
Choline Fenofibrate is the generic name for the brand Trilipix. 12 different companies have already filed for the generic of Trilipix, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Trilipix's generic
How can I launch a generic of Trilipix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trilipix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trilipix's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Trilipix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 45 mg | 02 Sep, 2009 | 1 | 07 Sep, 2016 | 07 Jan, 2025 | Extinguished |
| 135 mg | 01 Sep, 2009 | 1 | 07 Sep, 2016 | 07 Jan, 2025 | Extinguished |
About Trilipix
Trilipix is a drug owned by Abbvie Inc. Trilipix uses Choline Fenofibrate as an active ingredient. Trilipix was launched by Abbvie in 2008.
Approval Date:
Trilipix was approved by FDA for market use on 15 December, 2008.
Active Ingredient:
Trilipix uses Choline Fenofibrate as the active ingredient. Check out other Drugs and Companies using Choline Fenofibrate ingredient
Dosage:
Trilipix is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |
| EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE | Discontinued | ORAL |