Antara (micronized) Patent Expiration

Antara (micronized) is a drug owned by Lupin Inc. It is protected by 4 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 31, 2033. Details of Antara (micronized)'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).
US7863331 Pharmaceutical composition containing fenofibrate and method for the preparation thereof
Aug, 2020

(3 years ago)

Expired
US7101574 Pharmaceutical composition containing fenofibrate and the preparation method
Aug, 2020

(3 years ago)

Expired
US8026281 Treating metabolic syndrome with fenofibrate
Apr, 2025

(9 months from now)

Active
US9314447 Reduced dose pharmaceutical compositions of fenofibrate
May, 2033

(8 years from now)

Active

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US patents provide insights into the exclusivity only within the United States, but Antara (micronized) 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 Antara (micronized)'s family patents as well as insights into ongoing legal events on those patents.

Antara (micronized)'s family patents

Antara (micronized) has patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Antara (micronized).

Family Patents

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Generic Launch

Generic Release Date:

Antara (micronized)'s generic launch date based on the expiry of its last outstanding patent is estimated to be May 31, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Antara (micronized) Generics:

Fenofibrate is the generic name for the brand Antara (micronized). 33 different companies have already filed for the generic of Antara (micronized), with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Antara (micronized)'s generic

How can I launch a generic of Antara (micronized) before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Antara (micronized)'s patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Antara (micronized)'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 Antara (micronized) -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
43 mg and 130 mg 15 Sep, 2008 1 01 Mar, 2012 20 Aug, 2020 Extinguished




About Antara (micronized)

Antara (Micronized) is a drug owned by Lupin Inc. It is used for lowering cholesterol levels and treating high triglycerides. Antara (Micronized) uses Fenofibrate as an active ingredient. Antara (Micronized) was launched by Lupin in 2013.

Market Authorisation Date:

Antara (micronized) was approved by FDA for market use on 18 October, 2013.

Active Ingredient:

Antara (micronized) uses Fenofibrate as the active ingredient. Check out other Drugs and Companies using Fenofibrate ingredient

Treatment:

Antara (micronized) is used for lowering cholesterol levels and treating high triglycerides.

Dosage:

Antara (micronized) is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
43MG CAPSULE Prescription ORAL
130MG CAPSULE Prescription ORAL
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
90MG CAPSULE Discontinued ORAL