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EPANOVA Drug Profile
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Which patents cover Epanova, and when can generic versions of Epanova launch?
Epanova is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and thirteen patent family members in forty-two 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.
US ANDA Litigation and 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: | 113 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | EPANOVA at DailyMed |
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 |
|---|---|
| Cleveland Clinic Coordinating Center for Clinical Research (C5R) | Phase 3 |
| Quintiles, Inc. | Phase 3 |
| Omthera Pharmaceuticals, Inc | Phase 3 |
US Patents and Regulatory Information for EPANOVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for EPANOVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | Start Trial | Start Trial |
| Astrazeneca Pharms | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPANOVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 177462 | Start Trial |
| Russian Federation | 2018116572 | Start Trial |
| Russian Federation | 2664429 | Start Trial |
| Slovenia | 2800563 | Start Trial |
| Canada | 2555064 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
