Omega-3-carboxylic acids - Generic Drug Details
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What are the generic sources for omega-3-carboxylic acids and what is the scope of freedom to operate?
Omega-3-carboxylic acids
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Omega-3-carboxylic acids has eighty-four patent family members in forty countries.
There is one drug master file entry for omega-3-carboxylic acids.
Summary for omega-3-carboxylic acids
| International Patents: | 84 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 34 |
| DailyMed Link: | omega-3-carboxylic acids at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for omega-3-carboxylic acids
*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 omega-3-carboxylic acids
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mabaret Al-Asafara Hospitals | Phase 4 |
| Assiut University | Phase 4 |
| Al-Azhar University | Phase 1 |
US Patents and Regulatory Information for omega-3-carboxylic acids
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 omega-3-carboxylic acids
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for omega-3-carboxylic acids
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1755565 | CAPSULE MOLLE DE GELATINE COMPRENANT DE L'ACIDE GRAS POLYINSATURE OMEGA-3 (SOFT GELATIN CAPSULE COMPRISING OMEGA-3 POLYUNSATURATED FATTY ACID) | ⤷ Sign Up |
| Hungary | E039659 | ⤷ Sign Up | |
| Hong Kong | 1202073 | 游離酸形式的&OHgr;- 多不飽和脂肪酸的富含 組合物 (DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM -3 DPA) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
