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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9314447 | Reduced dose pharmaceutical compositions of fenofibrate |
May, 2033
(8 years from now) | Active |
| US8026281 | Treating metabolic syndrome with fenofibrate |
Apr, 2025
(3 months from now) | Active |
| US7101574 | Pharmaceutical composition containing fenofibrate and the preparation method |
Aug, 2020
(4 years ago) |
Expired
|
| US7863331 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof |
Aug, 2020
(4 years 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 Antara (micronized)'s patents.
Latest Legal Activities on Antara (micronized)'s Patents
Given below is the list of recent legal activities going on the following patents of Antara (micronized).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Mar, 2023 | US8026281 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Jun, 2022 | US7863331 |
| Email Notification Critical | 24 Nov, 2020 | US8026281 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 24 Nov, 2020 | US8026281 (Litigated) |
| Correspondence Address Change Critical | 23 Nov, 2020 | US8026281 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Nov, 2020 | US8026281 (Litigated) |
| Email Notification Critical | 09 Nov, 2020 | US8026281 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jun, 2020 | US8026281 (Litigated) |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed Critical | 17 Jun, 2020 | US8026281 (Litigated) |
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 17 Jun, 2020 | US8026281 (Litigated) |
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
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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) Generic API suppliers:
Fenofibrate is the generic name for the brand Antara (micronized). 34 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 |
Alternative Brands for Antara (micronized)
Antara (micronized) which is used for lowering cholesterol levels and treating high triglycerides., 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 |
| ||
| Salix |
| ||
| Skyepharma Ag |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fenofibrate, Antara (micronized)'s active ingredient. Check the complete list of approved generic manufacturers for Antara (micronized)
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 2004.
Approval Date:
Antara (micronized) was approved by FDA for market use on 30 November, 2004.
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 |
|---|---|---|---|
| 90MG | CAPSULE | Discontinued | ORAL |
| 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 130MG | CAPSULE | Prescription | ORAL |
| 43MG | CAPSULE | Prescription | ORAL |