Fenoglide is a drug owned by Salix Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 09, 2024. Details of Fenoglide's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7658944 | Solid dosage form comprising a fibrate |
Dec, 2024
(5 months ago) |
Expired
|
| US8481078 | Solid dosage form comprising a fibrate |
Oct, 2024
(7 months ago) |
Expired
|
| US9173847 | Tablet comprising a fibrate |
Oct, 2024
(7 months ago) |
Expired
|
| US8124125 | Solid dosage form comprising a fibrate |
Oct, 2024
(7 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 Fenoglide's patents.
Latest Legal Activities on Fenoglide's Patents
Given below is the list of recent legal activities going on the following patents of Fenoglide.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Aug, 2023 | US8124125 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jul, 2021 | US7658944 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Dec, 2020 | US8481078 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Aug, 2019 | US8124125 |
| Recordation of Patent Grant Mailed Critical | 09 Jul, 2013 | US8481078 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Jul, 2013 | US8481078 |
| Issue Notification Mailed Critical | 19 Jun, 2013 | US8481078 |
| Dispatch to FDC | 10 Jun, 2013 | US8481078 |
| Mail Response to 312 Amendment (PTO-271) Critical | 07 Jun, 2013 | US8481078 |
| Response to Amendment under Rule 312 Critical | 07 Jun, 2013 | US8481078 |
US patents provide insights into the exclusivity only within the United States, but Fenoglide 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 Fenoglide's family patents as well as insights into ongoing legal events on those patents.
Fenoglide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fenoglide's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 09, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fenoglide Generic API suppliers:
Fenofibrate is the generic name for the brand Fenoglide. 34 different companies have already filed for the generic of Fenoglide, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fenoglide's generic
How can I launch a generic of Fenoglide before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fenoglide's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fenoglide'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 Fenoglide -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 120 mg | 17 Mar, 2010 | 1 | 09 Dec, 2024 | Extinguished |
Alternative Brands for Fenoglide
Fenoglide which is used for treating hyperlipidemia and lowering cholesterol levels., has several other brand drugs using the same active ingredient (Fenofibrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Abbvie |
| ||
| Cipher Pharms Inc |
| ||
| Lupin |
| ||
| Skyepharma Ag |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fenofibrate, Fenoglide's active ingredient. Check the complete list of approved generic manufacturers for Fenoglide
About Fenoglide
Fenoglide is a drug owned by Salix Pharmaceuticals Inc. It is used for treating hyperlipidemia and lowering cholesterol levels. Fenoglide uses Fenofibrate as an active ingredient. Fenoglide was launched by Salix in 2007.
Approval Date:
Fenoglide was approved by FDA for market use on 10 August, 2007.
Active Ingredient:
Fenoglide uses Fenofibrate as the active ingredient. Check out other Drugs and Companies using Fenofibrate ingredient
Treatment:
Fenoglide is used for treating hyperlipidemia and lowering cholesterol levels.
Dosage:
Fenoglide is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120MG | TABLET | Discontinued | ORAL |
| 40MG | TABLET | Discontinued | ORAL |