Fenoglide Patent Expiration

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 none have expired yet. 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8124125 Solid dosage form comprising a fibrate
Oct, 2024

(2 months from now)

Active
US8481078 Solid dosage form comprising a fibrate
Oct, 2024

(2 months from now)

Active
US9173847 Tablet comprising a fibrate
Oct, 2024

(2 months from now)

Active
US7658944 Solid dosage form comprising a fibrate
Dec, 2024

(4 months from now)

Active

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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

Fenoglide has patent protection in a total of 12 countries. It's US patent count contributes only to 28.6% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Fenoglide.

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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 Generics:

Fenofibrate is the generic name for the brand Fenoglide. 33 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




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.

Market Authorisation 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 Prescription ORAL
40MG TABLET Prescription ORAL