EPANOVA Drug Patent Profile
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Which patents cover Epanova, and when can generic versions of Epanova launch?
Epanova is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.
This drug has eighty-four patent family members in forty countries.
The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.
DrugPatentWatch® Generic Entry Outlook for Epanova
Epanova was eligible for patent challenges on May 5, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 20, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for EPANOVA
International Patents: | 84 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 16 |
Patent Applications: | 316 |
Formulation / Manufacturing: | see details |
DailyMed Link: | EPANOVA at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity Date for EPANOVA
Generic Entry Date for EPANOVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for EPANOVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
IQVIA RDS Inc. | Phase 3 |
The Cleveland Clinic | Phase 3 |
Cleveland Clinic Coordinating Center for Clinical Research (C5R) | Phase 3 |
US Patents and Regulatory Information for EPANOVA
EPANOVA is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPANOVA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EPANOVA
DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SEVERE HYPERTRIGLYCERIDEMIA (500 MG/DL) IN ADULT PATIENTS AS AN ADJUNCT TO DIET
Type A gelatin capsule containing PUFA in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Type a gelatin capsule containing PUFA in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA
Type A gelatin capsule containing PUFA in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA
DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA
DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Type A gelatin capsule containing PUFA in free acid form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA
Expired US Patents for EPANOVA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | See Plans and Pricing | See Plans and Pricing |
Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPANOVA
When does loss-of-exclusivity occur for EPANOVA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7799
Estimated Expiration: See Plans and Pricing
Australia
Patent: 05215198
Estimated Expiration: See Plans and Pricing
Austria
Patent: 7720
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0507473
Estimated Expiration: See Plans and Pricing
Canada
Patent: 55064
Estimated Expiration: See Plans and Pricing
China
Patent: 29824
Estimated Expiration: See Plans and Pricing
Patent: 7690770
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 10030
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 55565
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 55565
Estimated Expiration: See Plans and Pricing
Patent: 89750
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2005019402
Estimated Expiration: See Plans and Pricing
Israel
Patent: 7462
Estimated Expiration: See Plans and Pricing
Japan
Patent: 35842
Estimated Expiration: See Plans and Pricing
Patent: 07522192
Estimated Expiration: See Plans and Pricing
Patent: 12149073
Estimated Expiration: See Plans and Pricing
Patent: 14139216
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 06008352
Estimated Expiration: See Plans and Pricing
Norway
Patent: 1821
Estimated Expiration: See Plans and Pricing
Patent: 064146
Estimated Expiration: See Plans and Pricing
Poland
Patent: 55565
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 55565
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 55565
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0606229
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1198458
Estimated Expiration: See Plans and Pricing
Patent: 070011307
Estimated Expiration: See Plans and Pricing
Spain
Patent: 44208
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 03247
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering EPANOVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2800563 | COMPOSITIONS ENRICHIES EN DPA D'ACIDES GRAS OMÉGA-3 POLYINSATURÉS SOUS FORME D'ACIDE LIBRE (DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 9636329 | See Plans and Pricing | |
Japan | 2012149073 | PHARMACEUTICAL COMPOSITION | See Plans and Pricing |
Peru | 20142459 | COMPOSICIONES ENRIQUECIDAS CON DPA DE ACIDOS GRASOS OMEGA 3 POLIINSATURADOS EN FORMA DE ACIDO LIBRE | See Plans and Pricing |
Hong Kong | 1251457 | 製備游離酸形式的ω-3多不飽和脂肪酸富含DPA的組合物的方法 (METHODS FOR MAKING DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |