Epanova is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 9 US drug patents filed from 2014 to 2018. Out of these, 7 drug patents are active and 2 have expired. Epanova's patents have been open to challenges since 05 May, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 04, 2033. Details of Epanova'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. | |||
| US9050309 | DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form |
Jan, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9050308 | DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form |
Jan, 2033
(8 years from now) | Active |
| US10117844 | DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form |
Jan, 2033
(8 years from now) | Active |
| US7960370 | Type A gelatin capsule containing PUFA in free acid form |
Dec, 2026
(2 years from now) | Active |
| US9012501 | Type A gelatin capsule containing PUFA in free acid form |
Feb, 2025
(2 months from now) | Active |
| US9132112 | Type A gelatin capsule containing PUFA in free acid form |
Feb, 2025
(2 months from now) | Active |
| US8383678 | Type a gelatin capsule containing PUFA in free acid form |
Feb, 2025
(2 months from now) | Active |
| US5948818 | Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids |
May, 2020
(4 years ago) |
Expired
|
| US5792795 | Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids |
May, 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 Epanova's patents.
Latest Legal Activities on Epanova's Patents
Given below is the list of recent legal activities going on the following patents of Epanova.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 23 Oct, 2023 | US9132112 |
| Expire Patent Critical | 17 Jul, 2023 | US9050309 |
| Expire Patent Critical | 17 Jul, 2023 | US7960370 |
| Expire Patent Critical | 17 Jul, 2023 | US9050308 |
| Expire Patent Critical | 29 May, 2023 | US9012501 |
| Maintenance Fee Reminder Mailed Critical | 08 May, 2023 | US9132112 |
| Maintenance Fee Reminder Mailed Critical | 30 Jan, 2023 | US9050309 |
| Maintenance Fee Reminder Mailed Critical | 30 Jan, 2023 | US7960370 |
| Maintenance Fee Reminder Mailed Critical | 30 Jan, 2023 | US9050308 |
| Expire Patent Critical | 12 Dec, 2022 | US10117844 |
FDA has granted several exclusivities to Epanova. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Epanova, 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 Epanova.
Exclusivity Information
Epanova holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Epanova's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 05, 2019 |
Several oppositions have been filed on Epanova's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Epanova's generic, the next section provides detailed information on ongoing and past EP oppositions related to Epanova patents.
Epanova's Oppositions Filed in EPO
Epanova has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 17, 2010, by Pronova Biopharma Norge As. This opposition was filed on patent number EP05702139A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05702139A | Nov, 2010 | Catalent Pharma Solutions, Inc. | Patent maintained as amended |
| EP05702139A | Nov, 2010 | S P A SOCIETA' PRODOTTI ANTIBIOTICI S.p.a. | Patent maintained as amended |
| EP05702139A | Nov, 2010 | Pronova Biopharma Norge AS | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Epanova 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 Epanova's family patents as well as insights into ongoing legal events on those patents.
Epanova's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epanova's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 04, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epanova Generics:
There are no approved generic versions for Epanova as of now.
About Epanova
Epanova is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for lowering high levels of triglycerides in adult patients. Epanova uses Omega-3-Carboxylic Acids as an active ingredient. Epanova was launched by Astrazeneca in 2014.
Approval Date:
Epanova was approved by FDA for market use on 05 May, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Epanova is 05 May, 2014, its NCE-1 date is estimated to be 05 May, 2018.
Active Ingredient:
Epanova uses Omega-3-carboxylic Acids as the active ingredient. Check out other Drugs and Companies using Omega-3-carboxylic Acids ingredient
Treatment:
Epanova is used for lowering high levels of triglycerides in adult patients.
Dosage:
Epanova is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS | CAPSULE | Discontinued | ORAL |