LOVAZA Drug Patent Profile
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When do Lovaza patents expire, and when can generic versions of Lovaza launch?
Lovaza is a drug marketed by Woodward and is included in one NDA.
The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lovaza
A generic version of LOVAZA was approved as omega-3-acid ethyl esters by GLW on April 7th, 2014.
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Questions you can ask:
- What is the 5 year forecast for LOVAZA?
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Summary for LOVAZA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 82 |
| Patent Applications: | 222 |
| Drug Prices: | Drug price information for LOVAZA |
| Drug Sales Revenues: | Drug sales revenues for LOVAZA |
| What excipients (inactive ingredients) are in LOVAZA? | LOVAZA excipients list |
| DailyMed Link: | LOVAZA at DailyMed |
Recent Clinical Trials for LOVAZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Prisma Health-Midlands | Phase 2/Phase 3 |
| H. Lee Moffitt Cancer Center and Research Institute | Phase 2 |
| James and Esther King Biomedical Research Program | Phase 2 |
Paragraph IV (Patent) Challenges for LOVAZA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LOVAZA | Capsules | omega-3-acid ethyl esters | 1 g | 021654 | 3 | 2008-11-10 |
US Patents and Regulatory Information for LOVAZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 LOVAZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LOVAZA
See the table below for patents covering LOVAZA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 453701 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004007655 | ⤷ Sign Up | |
| Denmark | 173371 | ⤷ Sign Up | |
| Sweden | 0202188 | ⤷ Sign Up | |
| Denmark | 2295529 | ⤷ Sign Up | |
| Australia | 2003249109 | A PROCESS FOR DECREASING THE AMOUNT OF CHOLESTEROL IN A MARINE OIL USING A VOLATILE WORKING FLUID | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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